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2004 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements

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Biologics:

Avastin (bevacizumab) (Posted 8/13/2004)
ORTHO Antibody to HBsAg ELISA Test System 3 (posted 1/9/2004)

Remicade (infliximab) (Posted 8/24/2004)

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Dietary Supplements:

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Drugs:

Abilify (aripiprazole) (Posted 4/12/2004)
Children's Motrin Grape Chewable Tablets (Posted 5/14/2004)
Clozaril (clozapine tablets) (Posted 4/7/2004)
Counterfeit contraceptive patches (Posted 2/6/2004)
Crestor (rosuvastatin) (Posted 6/9/2004)
Cytotec Solutions, Inc. Products (Posted 4/15/2004)
Desyrel (trazodone hydrochloride) (Posted 5/12/2004)
Domperidone (Posted 6/10/2004)
Duragesic (fentanyl transdermal system) (Posted 2/20/2004, update 4/9/2004)
Effexor and Effexor XR (venlafaxine HCl) (Posted 6/28/2004)
Geodon (ziprasidone) (Posted 8/31/2004)
Levoxyl (levothyroxine sodium) (Posted 10/04/2004)
Lovenox (enoxaparin sodium injection) (Posted 8/17/2004)
Major Twice-A-Day 12 Hour Nasal Spray (Posted 3/26/2004)
Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills (Posted 10/29/2004) New
OTC pain and fever reducers (acetaminophen / NSAIDs) (Posted 1/22/2004)
Oxandrin (oxandrolone, USP) (Posted 5/5/2004)
Paxil (paroxetine hydrochloride) (Posted 6/22/2004)
Protonix I.V. (pantoprazole sodium) (Posted 9/24/2004)
Public Health Advisory: Suicidality in Children and Adolescents Being Treated with Anti-depressant Medications (Posted 10/15/2004) New
Public Health Advisory: Antidepressant Use in Children, Adolescents, and Adults (Posted 3/22/2004)
Remicade (infliximab) (posted 10/13/2004) New
Reminyl (galantamine hydrobromide) (Posted 10/26/2004) New
Risperdal (risperidone) (Posted 8/4/2004)
Rituxan (rituximab) (Posted 10/08/2004)
Seroquel (quetiapine fumarate) (Posted 4/8/2004; UPDATE 4/22/2004)
Serzone (nefazodone hydrochloride) (Posted 6/23/2004)
Vioxx (rofecoxib) (Posted 9/30/2004)
Viramune (nevirapine) (Posted 2/2/2004)
Wellbutrin (bupropion hydrochloride) (Posted 6/22/2004)
Zelnorm (tegaserod maleate) (Posted 4/28/2004)
Zometa (zoledronic acid) Injection (Posted 9/30/2004)
Zyprexa (olanzapine) (Posted 3/22/2004)

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Medical Devices:

Absorbable Hemostatic Agents (Posted 4/2/2004)
Arjo Alenti Lift Hygiene Chair (Posted 7/13/2004)
Arjo MINSTREL Patient Lifts (Posted 5/27/2004)
Boston Scientific Express2™ (bare metal) Coronary Stent (Posted 7/23/2004)
Boston Scientific Taxus Coronary Stent (Posted 7/13/2004; UPDATED 8/6/2004)
Carl Zeiss Ophthalmic System (Posted 7/13/2004)
Faaborg Patient Lifts (Posted 3/11/2004)
Medibo Minerva Patient Lifts (Posted 9/3/2004; UPDATED 9/8/2004)
Medtronic 8870 Software Application Card Version AAA 02 (Posted 9/24/2004)
Medtronic Micro Jewell II Model 7223Cx and GEM DR Model 7271 Implantable Cardioverter Defibrillators (Posted 4/20/2004)
Nellcor CapnoProbe Sublingual Sensors (Posted 9/16/2004)
Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack (Posted 7/20/2004)
Paradigm Quick-set Plus Insulin Administration Set (Posted 5/20/2004)
PRECISE RX Nitinol Stent Transhepatic Biliary System (Posted 5/12/2004)
Pulmonetic Systems LTV Series of Ventilators (Posted 9/30/2004)
Roche Diagnostics Tecan Clinical Workstation (Posted 6/9/2004; UPDATED June 18, 2004)
Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers (Posted 7/23/2004)
Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Cannula (Posted 8/9/2004)
VITEK GPS-107 gram positive susceptibility cards (Posted 3/26/2004; UPDATED 5/14/2004)

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Other Products:

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2004 Medical Product Safety Alerts, listed in reverse chronological order (most recent first). For an alphabetical listing, return to the categories on this page. You may also search the entire MedWatch site by keyword at the top of this Safety Information page.

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Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills
Audience: Home healthcare, long-term care providers and consumers
Gillette and FDA notified healthcare professionals and consumers of a recall of Oral-B CrossAction Power and PowerMAX toothbrushes and refills. Instances have occurred where the brush head became loose in the mouth during the assisted brushing of teeth of persons with special needs, such as cerebral palsy or autism. During brushing, the loose brush head was caught in the throat or swallowed. Gillette recommended that consumers stop using these products to assist in brushing the teeth of people with special needs.

[October 27, 2004 - Firm Press Release - Gillette]

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Reminyl (galantamine hydrobromide)
Audience: Neuropsychiatric healthcare professionals and pharmacists
FDA, Janssen Pharmaceutica Products, and Johnson & Johnson Pharmaceutical Research & Development notified healthcare professionals of reports of medication errors involving confusion between Reminyl, a drug approved for the treatment of mild to moderate dementia of the Alzheimer's type, and Amaryl (glimepiride), a product of Aventis Pharmaceuticals, indicated for the treatment of non-insulin dependent (Type 2) diabetes mellitus. These reports include instances in which Reminyl was prescribed but Amaryl was incorrectly dispensed and administered instead, leading to various adverse events including severe hypoglycemia and one death.

[October 15, 2004 - Letter to Healthcare Professionals - Janssen]
[October 19, 2004 - Letter to Pharmacists - Janssen] PDF Format Adobe Acrobat [pdf] file

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Public Health Advisory: Suicidality in Children and Adolescents Being Treated with Antidepressant Medications
Audience: Neuropsychiatric healthcare professionals and consumers
The Food and Drug Administration issued a Public Health Advisory, asking manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and additional information about the results of pediatric studies. FDA also informed these manufacturers that it has determined that a Patient Medication Guide (MedGuide), which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken, is appropriate for these drug products.

[October 15, 2004 - Public Health Advisory - FDA]
[October 15, 2004 - Drug Information Page - FDA]

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Remicade (infliximab)
Audience: Rheumatologists, gastroenterologists and other healthcare professionals
FDA and Centocor notified healthcare professionals of revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for Remicade, indicated for the treatment of rheumatoid arthritis and Crohn's disease. In controlled studies of all TNFα-blocking agents, including Remicade, more cases of lymphoma have been observed among patients receiving the agents than among control group patients. Malignancies have also been observed in open-label, uncontrolled clinical studies at a rate several-fold higher than expected in the general population. Patients with Crohn's disease or rheumatoid arthritis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma. FDA has recommended a warning concerning malignancy be added to the labeling for all therapeutic agents that block TNF.

[October, 2004 - Letter - Centocor] Adobe Acrobat [pdf] file
[October, 2004 - Label - Centocor] Adobe Acrobat [pdf] file

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Rituxan (rituximab)
Audience: Oncologists, hematologists and other healthcare professionals
Biogen Idec and Genentech notified healthcare professionals of revisions to the WARNINGS section of the prescribing information due to reports of Hepatitis B virus (HBV) reactivation with fulminant hepatitis, hepatic failure, and death in some patients with hematologic malignancies. Persons at high risk of HBV infection should be screened before initiation of Rituxan. Carriers of hepatitis B should be closely monitored for clinical and laboratory signs of active HBV infection and for signs of hepatitis during and for up to several months following Rituxan therapy.

[July 12, 2004 - Letter - Genentech/Biogen Idec] Adobe Acrobat [pdf] file
[June 2004 Label - Genentech/Biogen Idec] Adobe Acrobat [pdf] file

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Levoxyl (levothyroxine sodium)
Audience: Endocrinologists and other healthcare professionals
FDA and King Pharmaceuticals notified healthcare professionals of revisions to the PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of labeling, describing reports of choking, gagging, tablets stuck in throat and dysphagia while taking Levoxyl. These reports have predominately occurred when Levoxyl tablets were not taken with water. It is recommended that Levoxyl tablets be taken with a full glass of water.

[September 17, 2004 Letter - King Pharmaceuticals] Adobe Acrobat [pdf] file
[May 2004 Label - King Pharmaceuticals] Adobe Acrobat [pdf] file

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Pulmonetic Systems LTV Series of Ventilators
Audience: Respiratory healthcare professionals and risk managers
FDA and Pulmonetic Systems, Inc. notified healthcare professionals of a Class I recall of the LTV series of ventilators, models 1000, 950, 900 and 800, designed to automatically switch to internal battery operation, allowing uninterrupted ventilation, when an external power source is removed or is no longer adequate to power the ventilator. The ventilators malfunction when switching to the internal battery, causing failure of the ventilator to breathe for the patient.

[September 30, 2004 Recall Notice - FDA] Adobe Acrobat [pdf] file

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Zometa (zoledronic acid) Injection
Audience: Oncologists, dentists, and other healthcare professionals
FDA and Novartis notified healthcare professionals of revisions the PRECAUTIONS and ADVERSE REACTIONS sections of labeling, describing spontaneous reports of osteonecrosis of the jaw mainly in cancer patients, who have received bisphosphonates as a component of their therapy. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene). 

[September 24, 2004 Letter - Novartis] Adobe Acrobat [pdf] file
[August 2004 Label - Novartis] Adobe Acrobat [pdf] file

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Vioxx (rofecoxib)
Audience: Healthcare professionals and consumers
Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx.  Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. 

[September 30, 2004 Public Health Advisory - FDA]
[September 30, 2004 Press Release - FDA]
[September 30, 2004 Questions and Answers (Q&As) - FDA]

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Medtronic 8870 Software Application Card Version AAA 02
Audience: Healthcare professionals and risk managers
FDA and Medtronic notified healthcare professionals of a Class I recall of all Medtronic Model 8870 software application cards, Version AAA 02, used in conjunction with the Model 8840 N'Vision Clinician Programmer. This software application card is used to control the administration of medication of Synchromed and Synchromed EL implantable infusion pumps. Several pump infusion modes require the entry of a time duration or interval. Medtronic has received reports of the entry of hours into the minutes field, which has resulted in deaths and injuries due to drug overdose.

[September 23, 2004 Recall Notice - FDA]

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Protonix I.V. (pantoprazole sodium)
Audience: Pharmacists, nurses and other healthcare professionals in institutional settings
Wyeth and FDA informed healthcare professionals of reports of glass vial breakage of Protonix I.V. during attempts to connect vials to spiked intravenous system adaptors. This may be a safety issue for pharmacists or nurses when preparing Protonix I.V. for Injection vials in combination with spiked intravenous system adaptors, both during manual assembly and while utilizing mechanical assistance.

[August 2004 Letter - Wyeth] Adobe Acrobat [pdf] file
[June 2004 Label - Wyeth] Adobe Acrobat [pdf] file

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Nellcor CapnoProbe Sublingual Sensors
Audience: Hospitals and risk managers
FDA and Tyco Healthcare/Nellcor notified consumers and healthcare professionals of a Class I recall for all of its CapnoProbe Sublingual Sensors, a device similar to an electronic thermometer that is used by hospitals to measure the carbon dioxide in patients' tissues. The probe and associated saline contain the bacteria Burkholderia Cepacia and other opportunistic pathogens that can cause serious infections, usually in persons who have decreased resistance to infection.

[September 15, 2004 Recall Notice - FDA]

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Medibo Minerva Patient Lifts
Audience: Hospital and nursing home administrators and risk managers
FDA and Medibo, N.V., Hanmont, Achel: Belgium notified healthcare professionals of a Class I recall of the Minerva Patient Lift (models ML-20 and ML-30), a battery operated lift designed for lifting and transport of patients. There are three mechanical problems for which the Minerva patient lift is currently being recalled. The first involves the hanger bar detaching from the lift resulting in the patient falling to the ground because of a missing spring washer. The second problem involves a bolt in the foot pedal assembly becoming loose which allows the foot pedal assembly to fall off of the lift. This results in the lift becoming unstable and the patient possibly falling. Thirdly, some units may have faulty actuator brackets on the mast assembly that can also cause the lift to become unstable.

[UPDATE September 7, 2004 - Recall notice modified to correct name of recalling firm and contact telephone numbers]

[Sept 2, 2004 Recall Notice - FDA]

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Geodon (ziprasidone)
Audience: Neuropsychiatric healthcare professionals
FDA and Pfizer notified healthcare professionals of revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Geodon. FDA has asked all manufacturers of atypical antipsychotic medications, including Pfizer, to add this Warning statement to labeling.

[August, 2004 Letter - Pfizer] Adobe Acrobat [pdf] file
[July 2004 Revised Label - Pfizer] Adobe Acrobat [pdf] file

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Remicade (infliximab)
Audience: Rheumatologists, Gastroenterologists, and other healthcare professionals
FDA and Centocor revised the WARNINGS and ADVERSE REACTIONS sections of the labeling for Remicade, indicated for the treatment of rheumatoid arthritis and Crohn's disease. Cases of leukopenia, neutropenia and pancytopenia, some with fatal outcome, and cases of CNS manifestation of systemic vasculitis, were described in patients receiving Remicade. The ADVERSE REACTIONS section was updated to include neutropenia, pericardial effusion and systemic and cutaneous vasculitis.

[August 11, 2004 Letter - Centocor] Adobe Acrobat [pdf] file
[July 2004 Revised Label - Centocor] Adobe Acrobat [pdf] file

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Lovenox (enoxaparin sodium injection)
Audience: Physicians, pharmacists, and other healthcare providers
FDA and Aventis Pharmaceuticals revised the CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of labeling, describing the need for a dosage adjustment for patients with severe renal impairment (creatinine clearance <30mL/min) who have increased exposure to enoxaparin. No specific dosage adjustment is required in patients with mild or moderate renal impairment and in low-weight patients. However, low-weight patients should be observed carefully for signs and symptoms of bleeding.

[March 2004 Letter - Aventis] Adobe Acrobat [pdf] file
[July 2004 Label - Aventis] Adobe Acrobat [pdf] file

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Avastin (bevacizumab)
Audience: Oncologists and other healthcare providers
FDA and Genentech, Inc. issued an important drug warning to healthcare providers that there is evidence of an increased risk of serious arterial thromboembolic events, including cerebrovascular accident, myocardial infarctions, transient ischemic attacks, and angina related to Avastin. The risk of fatal arterial thrombotic events is also increased. In randomized, active-controlled studies conducted in patients with metastatic colorectal cancer, the risks of a serious arterial thrombotic event was approximately two-fold higher in patients receiving infusional 5-FU based chemotherapy plus Avastin, with an estimated overall rate of up to 5%. A revised Avastin package insert containing more detailed information on arterial thromboembolic events is in development. The current Avastin package insert is provided below.

[August 12, 2004 Letter - Genentech] Adobe Acrobat [pdf] file
[April 2004 Label - Genentech] Adobe Acrobat [pdf] file

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Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula
Audience: Respiratory healthcare professionals, operating room supervisory personnel, and risk managers
FDA and Nellcor/Tyco notified healthcare professionals of a Class I recall of the Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Cannula. This recall affects 73,355 disposable units that the firm has shipped to U.S. and international customers over the last four years. The tracheostomy tube is secured in place through the tube's hub and flange assembly with the use of a holder or neck strap. The outer cannula may separate from the hub and neck flange allowing the outer cannula to travel farther into the patient's airway, leading to obstruction of the airway and subsequent lack of ventilation. Airway obstruction or failure to ventilate can lead to permanent neurological injury or death.

[August 9, 2004 Recall Notice - FDA]

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Risperdal (risperidone)
Audience: Neuropsychiatric healthcare professionals
FDA and Janssen revised the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Risperdal. MedWatch is posting a revised version of a letter originally distributed to health care professionals November 2003. FDA asked all manufacturers of atypical antipsychotic medications, including Janssen, to add this Warning statement to labeling.

[July 2004 Letter - Janssen Pharmaceutica, Inc.]
[December 2003 Revised Label - Janssen Pharmaceutica, Inc.] Adobe Acrobat [pdf] file

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Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers
Audience: Clinical laboratory specialists and healthcare professionals
FDA and Roche Molecular Systems notified healthcare professionals of a Class 1 recall of the Roche COBAS TaqMan and TaqMan 48 Analyzer, used for the measurement of Hepatitis B and Hepatitis C viruses and for other in-house diagnostic testing. The analyzers produced falsely elevated values due to the improper seating of a fiber optic cable in the analyzer instrument. FDA considers that the probability of life threatening consequences is likely to occur by the malfunctioning of these devices.

[July 22, 2004 Recall Notice - FDA]

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Boston Scientific Express2TM (bare metal) Coronary Stent
Audience: Cardiologists, operating room supervisory personnel, and risk managers
FDA and Boston Scientific Corporation notified healthcare professionals of a Class 1 recall of the Boston Scientific Express2TM (bare metal) coronary stent system. Characteristics in the design of this stent system resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement. Impeded balloon deflation can result in significant patient complications, including emergency coronary artery bypass graft surgery and death. Hospitals should immediately discontinue use of any affected units.

[July 22, 2004 Recall Notice - FDA]

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Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack
Audience: Clinical laboratory specialists, risk managers
FDA and Ortho-Clinical Diagnostics notified healthcare professionals of a Class I recall of four lots of the VITROS Troponin I Reagent Pack, a laboratory test used by professionals to measure the quantity of cardiac troponin I in human blood to aid in the diagnosis of heart attack. The recall was initiated due to random occurrences of false positive test results which could lead to unnecessary medical procedures. Clinical laboratories were instructed by the firm to stop using the product, discard any remaining material and notify the health care provider who ordered the test. FDA considers that the probability of life threatening consequences is likely to occur by use of these products.

[July 19, 2004 Recall Notice - FDA]

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Boston Scientific Taxus Coronary Stent
Audience: Cardiologists, operating room supervisory personnel, and risk managers
FDA and Boston Scientific Corporation notified healthcare professionals of a Class I recall of two lots of the Taxus drug-eluting coronary stent system (lots 6294706 and 6365192). Characteristics in the design of these two lots resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement. Impeded balloon deflation can result in significant patient complications, including emergency coronary artery bypass graft surgery and death.

[UPDATE August 6, 2004 - additional lots recalled]
[July 9, 2004 Recall Notice - FDA]

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Arjo Alenti Lift Hygiene Chair
Audience: Hospital and nursing home administrators and risk managers
FDA and Arjo Inc. notified healthcare professionals of a Class I recall of the Alenti Lift Hygiene Chair, a battery operated lift designed for lifting, moving and bathing of patients. There have been an increased number of incidents of the lifts tipping which have resulted in serious injuries to the patients. Reported causes of the incidents include lift instability on sloped floors, casters falling off of the lift while in use, patients leaning or shifting weight in the seat, and brakes not being applied. Additionally, the device labeling does not properly instruct the health care professional on how to properly secure the patient.

[July 9, 2004 Recall Notice - FDA]
[July 7, 2004 Press Release - FDA]

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Carl Zeiss Ophthalmic System
VISULAS 532s with VISULINK 532/U surgical laser instrument
Audience: Ophthalmologists, operating room supervisory personnel, and risk managers
FDA and Carl Zeiss Meditec notified healthcare professionals of a Class I recall of one lot of VISULINK 532/U that may contain a defective mirror coating. This medical device is intended for use in laser treatment of diseases of the eye, particularly in treating retinal detachments or bleeding of the retina. The faulty mirror may misdirect the laser beam to an unintended target in or on the eye resulting in retinal bleeding and/or burns due to excessive laser energy in the eye.

[July 9, 2004 Recall Notice - FDA]
[July 9, 2004 Press Release - FDA]

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Effexor (venlafaxine HCl)
Effexor XR (venlafaxine HCl)
Audience: Neuropsychiatric, obstetric and neonatology healthcare professionals
FDA and Wyeth Pharmaceuticals notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of labeling to alert healthcare providers of two important safety issues.

Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery.

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

[June 3, 2004 Letter - Wyeth] Adobe Acrobat [pdf] file
[May 2004 Effexor Revised Label - Wyeth] Adobe Acrobat [pdf] file
[May 2004 Effexor XR Revised Label - Wyeth] Adobe Acrobat [pdf] file

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Serzone (nefazodone hydrochloride) Tablets
Audience: Neuropsychiatric healthcare professionals
FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, and WARNINGS sections to encourage healthcare providers to engage in a thorough risk-benefit analysis, including consideration of the risk of hepatic failure associated with Serzone treatment, when deciding among alternative treatments available for depression. In addition, healthcare providers and consumers are cautioned about the need for close observation of patients being treated with antidepressants for clinical worsening of the symptoms of depression, for the emergence of suicidality, and for the emergence of a variety of other symptoms that may represent a worsening of the patient's condition.

[June 18, 2004 Letter - Bristol-Myers Squibb] Adobe Acrobat [pdf] file
[April 2004 Revised Label - Bristol-Myers Squibb] Adobe Acrobat [pdf] file

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Wellbutrin (bupropion hydrochloride) Tablets
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets
Audience: Neuropsychiatric healthcare professionals
FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

[May 2004 Letter - GlaxoSmithKline] Adobe Acrobat [pdf] file
[April 2004 Wellbutrin XL Revised Label - GlaxoSmithKline] Adobe Acrobat [pdf] file

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Paxil (paroxetine hydrochloride) Tablets
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets
Audience: Neuropsychiatric healthcare professionals
FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

[May 2004 Letter - GlaxoSmithKline] Adobe Acrobat [pdf] file
[April 2004 Paxil Revised Label - GlaxoSmithKline] Adobe Acrobat [pdf] file
[April 2004 Paxil CR Revised Label - GlaxoSmithKline] Adobe Acrobat [pdf] file

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Domperidone
Audience: Consumers and healthcare professionals
FDA warned healthcare professionals and breastfeeding women not to use an unapproved drug, domperidone, to increase milk production (lactation). The agency is concerned with the potential public health risks associated with domperidone. FDA took these actions because it has become aware that some women are purchasing this drug from compounding pharmacies and from foreign sources. Although domperidone is approved in several countries outside the U.S. to treat certain gastric disorders, it is not approved in any country, including the U.S., for enhancing breast milk production in lactating women and is also not approved in the U.S. for any indication.

[June 10, 2004 FDA Talk Paper - FDA]

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Roche Diagnostics Tecan Clinical Workstation
Audience: Clinical laboratory specialists and healthcare professionals
FDA and Roche Diagnostics notified healthcare professionals of a Class I Recall for the Tecan Clinical Workstation (TCW), used with Roche Diagnostics Amplicor CT/NG test for the detection of Chlamydia and gonorrhea. A software error in the workstation software may cause a mismatch among patient samples and test results resulting in false positive and false negative results. This could lead to mistreatment and unneeded exposure to antibiotics. Untreated Chlamydia and gonorrhea infections may lead to pelvic inflammatory disease, infertility, ectopic pregnancy, or other conditions.

[UPDATE June 18, 2004 - Recall information added for COBAS GUI Interface and RoboNet software]
[June 09, 2004 Recall Notice - FDA]

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Crestor (rosuvastatin)
Audience: Physicians, pharmacists, and other healthcare professionals
FDA issued a Public Health Advisory notifying healthcare professionals of a revised package insert for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to adverse event reports in patients receiving Crestor and highlight certain patient populations who may be at an increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg. These risk factors and many of the recommendations for how to minimize the risk of myopathy are already captured in the FDA approved labeling for Crestor in the U.S. FDA alerted physicians to carefully read the Crestor product label and follow the recommendations for starting doses, dose adjustments, and maximum daily doses to minimize the risk of myopathy in individual patients.

[June 09, 2004 Public Health Advisory - FDA]

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Arjo MINSTREL Patient Lifts
Audience: Hospital and nursing home administrators and risk managers
FDA and Arjo, Inc. notified healthcare professionals of a Class I recall of the MINSTREL patient lift. There are two mechanical problems associated with the lifts: the first involves the hanger bar detaching from the lift, resulting in the patient falling to the ground because of a missing spring washer; the second problem involves a bolt in the foot pedal assembly becoming loose which allows the foot pedal assembly to fall off of the lift. This results in the lift becoming unstable and the patient possibly falling. Facilities should either inspect their lifts and follow the instructions in the Field Correction/Recall letter sent to all facilities or they should take the lifts out of service until they can be inspected by an Arjo service engineer.

[May 27, 2004 Recall Notice - FDA]
[May 26, 2004 Press Release - Arjo, Inc.]

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Paradigm Quick-set Plus Insulin Administration Set
Audience: Healthcare professionals, hospital risk managers
FDA and Medtronic, Inc. notified healthcare professionals of a Class I recall of Quick-set Plus infusion sets because of problems with bending of the infusion set's cannula or unintentional disconnection of the set at the insertion site that can interrupt insulin flow to diabetics who use them. These problems have resulted in a number of serious injuries, including some hospitalizations.

[May 20, 2004 Recall Notice - FDA]
[May 18, 2004 Press Release - Medtronic, Inc.]

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Children's Motrin Grape Chewable Tablets
Audience: Pharmacists and consumers
FDA and McNeil alerted healthcare professionals that one manufacturing lot (Lot # JAM108, exp 1/06) of Children's Motrin (ibuprofen) Grape Chewable Tablets may mistakenly contain Tylenol 8-Hour extended release (acetaminophen) Geltabs. Lot # JAM108 was distributed nationwide to wholesale and retail customers between February 5 and April 1, 2004. The bottles are labeled as containing 24 tablets. The Tylenol 8-Hour product provides an adult dose of acetaminophen, and use of this adult product could provide more than the recommended dose (overdose) for children.

[May 12, 2004 Press Release - McNeil Consumer & Specialty Pharmaceuticals]

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PRECISE RX Nitinol Stent Transhepatic Biliary System
Audience: General surgeons and endovascular healthcare professionals
Cordis and FDA notified healthcare professionals of a Class 1 recall for the revised instructions for use, not cleared by the FDA, and contained in a notification mailed to Cordis' endovascular customers on March 29, 2004. Use of the stent system, indicated for treatment of obstruction of the bile duct due to malignancies, is reported to result in serious problems in some cases when used in the vascular system.

On May 4, 2004 Cordis sent a follow-up notification to customers describing nine patient injuries due to air embolism, including seizure and coma, as well as seven incidents of device malfunction in connection with the use of this system outside of its approved indication. Cordis stated that they were recalling the March 29, 2004 instructions with a strong recommendation that physicians limit their use of the PRECISE RX Stent to indicated uses only.

[May 04, 2004 Recall Notice - FDA]

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Desyrel (trazodone hydrochloride)
Audience: Neuropsychiatric healthcare professionals
FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the Desyrel labeling. Desyrel is indicated for the treatment of depression. In vitro drug metabolism studies suggest that there is a potential for drug interactions when trazodone is given with the CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir. It is likely that CYP3A4 inhibitors may lead to substantial increases in trazodone plasma concentrations with the potential for adverse effects. If trazodone is used with a potent CYP3A4 inhibitor, a lower dose of trazodone should be considered. Conversely, carbamazepine reduced plasma concentrations of trazodone when coadministered. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taken with carbamazepine.

[May, 2004 Letter - Bristol-Myers Squibb] Adobe Acrobat [pdf] file
[September, 2003 Label - Bristol-Myers Squibb] Adobe Acrobat [pdf] file

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Oxandrin (oxandrolone, USP)
Audience: Physicians, pharmacists, and other healthcare professionals
Savient Pharmaceuticals, Inc. notified healthcare professionals of an important drug interaction between Oxandrin, a synthetic derivative of testosterone, and the oral anticoagulant warfarin for systemic anticoagulation. Oxandrin is indicated as adjunctive therapy to promote weight gain and for the relief of the bone pain frequently accompanying osteoporosis. Concurrent dosing of Oxandrin and warfarin may result in unexpectedly large increases in the International Normalized Ratio (INR) or prothrombin time (PT). When Oxandrin is prescribed to patients being treated with warfarin, doses of warfarin may need to be decreased significantly to maintain a desirable INR level and diminish the risk of potentially serious bleeding.

[April 20, 2004 Letter - Savient Pharmaceuticals]

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Zelnorm (tegaserod maleate)
Audience: Gastroenterologists and other healthcare professionals
The FDA and Novartis notified healthcare professionals of an important drug warning and prescribing information for Zelnorm, a serotonin 5-HT4 receptor partial agonist indicated for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. This new information relates to a Warning for serious consequences of diarrhea and a Precaution for rare reports of ischemic colitis in post marketing use of Zelnorm.

[April 26, 2004 Letter - Novartis] Adobe Acrobat [pdf] file
[April 2004 Revised Label - Novartis] Adobe Acrobat [pdf] file
[April 28, 2004 Drug Information Page - FDA]

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Medtronic Micro Jewell II Model 7223Cx and GEM DR Model 7271 Implantable Cardioverter Defibrillators (ICD)
Audience: Cardiologists and other healthcare professionals
The FDA notified healthcare professionals of a Class I recall of implantable cardioverter defibrillators (ICDs) from Medtronic Inc. of Minneapolis, Minnesota. Some Medtronic ICDs were found to have defective high voltage capacitors that may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or a non-delivery of shock therapy. This could result in patient injury or death because patients are not receiving the appropriate therapy in time. A total of 6,268 of the affected ICDs were manufactured, of which about 1,800 are thought to be still implanted in patients worldwide. Patients with Medtronic ICDs with these model numbers should contact their physicians for further information and advice.

[April 4, 2004 Recall Notice - FDA]
[April 16, 2004 Press Release - Medtronic]

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Cytotec Solutions, Inc. Products
Audience: Consumers, pharmacists, and other healthcare professionals
FDA warned consumers not to purchase or consume products marketed as "street drug alternatives" by Cytotec Solutions, Inc., of Tampa, Fla. FDA analyses of products manufactured or distributed by Cytotec Solutions Inc., found the drugs diphenhydramine HCl, dextromethorphan, ephedrine, and the controlled substances GBL and GHB. Although this firm is no longer producing these products, they remain under investigation and FDA is working to identify and address additional distributors of the products. The agency is issuing this warning because consumers may still have these products in their possession or may be able to buy them commercially. A list of product names is included in the FDA Press Release.

[April 9, 2004 Press Release - FDA]


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Abilify (aripiprazole)
Audience: Neuropsychiatric healthcare professionals
FDA and Bristol-Myers Squibb notified healthcare professionals of revision to the WARNINGS section of labeling, describing the risk of hyperglycemia and diabetes in patients taking Abilify. FDA asked all manufacturers of atypical antipsychotic medications, including Bristol-Myers Squibb, to add this Warning statement to labeling.

[March 25, 2004 Letter - FDA]
[March, 2004 Revised label - Bristol-Myers Squibb] Adobe Acrobat [pdf] file

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Seroquel (quetiapine fumarate)
Audience: Neuropsychiatric healthcare professionals
FDA and AstraZeneca notified healthcare professionals of revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Seroquel. FDA has asked all manufacturers of atypical antipsychotic medications, including AstraZeneca, to add this Warning statement to labeling.

[UPDATE - April 22, 2004 Letter - AstraZeneca] Adobe Acrobat [pdf] file
[January 30, 2004 Letter - AstraZeneca]
[January 2004 Revised Label - AstraZeneca] Adobe Acrobat [pdf] file

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Clozaril (clozapine)
Audience: Neuropsychiatric healthcare professionals
FDA and Novartis notified healthcare professionals of revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Clozaril. FDA has asked all manufacturers of atypical antipsychotic medications, including Novartis, to add this Warning statement to labeling.

[April 1, 2004 Letter - Novartis] Adobe Acrobat [pdf] file
[December 2003 Revised Label - Novartis] Adobe Acrobat [pdf] file

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Absorbable Hemostatic Agents
Audience: Surgeons and operating room supervisory personnel
The FDA Center for Devices and Radiological Health (CDRH) issued a Public Health Notification concerning a serious adverse event that can occur with the use of an absorbable hemostatic agent, a device used to promote coagulation and stop internal bleeding during surgical procedures. Since 1996, FDA has received reports of over 110 adverse events related to absorbable hemostatic agents. Eleven of the events resulted in paralysis or other neural deficits. These events continue to occur despite specific advice and warnings in the device labeling. CDRH provided recommendations to minimize the risk of adverse events in patients receiving an absorbable hemostatic agent during a surgical procedure.

[April 02, 2004 Public Health Notification - FDA]

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VITEK GPS-107 gram positive susceptibility cards
Audience: Clinical laboratory specialists and healthcare professionals
(March 26, 2004) bioMerieux, Inc. of Hazelwood, Missouri issued a Class I recall of VITEK GPS-107 gram positive susceptibility cards, lot M83X, catalog #V4368. These cards are used with the VITEK System in clinical laboratories as a in-vitro test to determine patient's susceptibility of various bacteria to antibiotic treatment. Some of the GPS-107 cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. Use of the defective cards may pose a risk of potentially life threatening consequences due to inaccurate test results. (Updated 4/1/2004 to provide correct lot number.)

(UPDATE May 14, 2004) bioMerieux expanded its recall to include an additional lot, B28E.

[April 20, 2004 Recall Notice - FDA]
[January 28, 2004 Recall Notice - FDA]

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Major Twice-A-Day 12 Hour Nasal Spray
Audience: Pharmacists and consumers
Propharma, Inc., Miami, Florida issued a recall of Major Twice-A-Day 12 Hour Nasal Spray (Lot #K4496, Exp 10/06) because the lot was contaminated with Burkholderia cepacia bacteria. This product is a nasal decongestant containing the active ingredient oxymetazoline hydrochloride 0.05%. The entire lot was distributed nationwide to wholesalers, pharmacies, hospitals and retailers. Use of this contaminated product could cause serious or potentially life-threatening infections in patients with compromised immune systems, particularly individuals with cystic fibrosis. The lot number and expiration date are found on the bottom of the carton and the back of the bottle label.

[UPDATE March 26, 2004 Press Release - Propharma]
[March 18, 2004 Press Release - Propharma]

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Zyprexa (olanzapine)
Audience: Neuropsychiatric healthcare professionals
FDA and Lilly notified healthcare professionals of revision to the WARNINGS section of labeling, describing the increased risk of hyperglycemia and diabetes in patients taking Zyprexa. FDA has asked all manufacturers of atypical antipsychotic medications, including Lilly, to add this Warning statement to labeling.

[March 2004 Letter - Lilly] PDF version Adobe Acrobat [pdf] file
[January 2004 Revised Label - Lilly] Adobe Acrobat [pdf] file

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Public Health Advisory: Antidepressant Use in Children, Adolescents, and Adults
Audience: Neuropsychiatric healthcare professionals and consumers
The FDA asked manufacturers of the following antidepressant drugs to include in their labeling a Warning statement that recommends close observation of adult and pediatric patients for worsening depression or the emergence of suicidality when treated with these agents. The drugs that are the focus of this new Warning are: Prozac (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone); and Remeron (mirtazapine).

[March 22, 2004 Public Health Advisory - FDA]
[March 22, 2004 Drug Information Page - FDA]

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Faaborg Patient Lifts
Audience: Hospital and nursing home administrators and risk managers
The FDA notified healthcare professionals of a Class I recall of Faaborg battery operated patient lifts distributed by Moving Solutions, Inc., of Downers Grove, Ill., because of a faulty design. Excessive wear of the main bolt, which secures the lift arm to the main frame of the patient lift, will cause the bolt to break which will cause the patient to fall and could result in serious injury, even death. FDA has received one report of death related to the failure of the bolt. Facilities should stop using these lifts until the problem is corrected.

[March 09, 2004 Recall Notice - FDA]
[March 09, 2004 Press Release - FDA]

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Duragesic (fentanyl transdermal system)
Audience: Pharmacists, other healthcare professionals, and consumers
(February 20, 2004) Janssen Pharmaceutica and FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) is subject to this recall. A potential seal breach on one edge may allow drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications. Conversely, if the hydrogel contents leak out of the patch, there may not be adequate medication to treat the patients' pain. In an opioid tolerant patient, this may lead to withdrawal symptoms, which include sweating, sleeplessness and abdominal discomfort.

(UPDATE April 9, 2004) Janssen expanded its US recall to include 5 manufacturing lots. See updated information below.

[UPDATE April 7, 2004 Pharmacist Recall Notification - Janssen] Adobe Acrobat [pdf] file
[UPDATE April 2, 2004 Dear Health Care Professional Letter - Janssen] Adobe Acrobat [pdf] file
[February 17, 2004 Recall Notice - Janssen] Adobe Acrobat [pdf] file
[February 17, 2004 Product Photos - Janssen]
[February 16, 2004 Patient and Caregiver Information - Janssen]


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Counterfeit contraceptive patches
Audience: Reproductive healthcare professionals and consumers
FDA and Johnson and Johnson Co. of Raritan, NJ are warning the public about an overseas internet site selling counterfeit contraceptive patches that contain no active ingredients.The counterfeit contraceptive patches were promoted as Ortho Evra transdermal patches, which are FDA approved, and made by Johnson and Johnson's Ortho-McNeil Pharmaceutical, Inc. subsidiary. These counterfeit patches provide no protection against pregnancy. Consumers who have any of these products should not use them, but instead contact their healthcare providers immediately.

[February 4, 2004 Talk Paper - FDA]

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Viramune (nevirapine)
Audience: Infectious disease and other healthcare professionals
Boehringer Ingelheim and FDA notified healthcare professionals of new safety information added to the WARNINGS and Boxed Warning for VIRAMUNE. Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, has been reported in patients treated with VIRAMUNE. These events are often associated with rash. Women, and patients with higher CD4 counts, are at increased risk of these hepatic events. Women with CD4 counts >250 cells/mm3, including pregnant women receiving chronic treatment for HIV infection, are at considerably higher risk of these events. Prodromal signs and symptoms, risk information and monitoring recommendations have been added to the labeling.   

[February 2004 Letter - Boehringer Ingelheim] Adobe Acrobat [pdf] file
[February 2004 Revised label - Boehringer Ingelheim] Adobe Acrobat [pdf] file
[January 2004 Guidelines: Management of Rash/Hepatic Events with Viramune - Boehringer Ingelheim] Adobe Acrobat [pdf] file

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OTC pain and fever reducers (acetaminophen / NSAIDs)
Audience: Pharmacists, other healthcare professionals, and consumers
The FDA notified healthcare professionals of a national education campaign to provide advice on the safe use of over-the-counter (OTC) pain and fever reducers that contain acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs). The campaign is intended to raise consumer awareness of these safety issues and to inform healthcare providers about the role that they can play in preventing acetaminophen induced hepatotoxicity and NSAID-related gastrointestinal bleeding and renal toxicity in patients using these medicines.

[January 22, 2004 Drug Information Page - FDA]
[January 22, 2004 Science Backgrounder - FDA]
[January 22, 2004 Letter to State Boards of Pharmacy - FDA]
[January 22, 2004 Press Release - FDA]

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Antibody to HBsAg ELISA Test System 3
Antibody to HBsAg ELISA Test System 3 Confirmatory Test
Audience: Blood bank and other laboratory professionals
Ortho-Clinical Diagnostics Inc. and FDA notified healthcare professionals of reports of increased initial reactive (IR) and repeat reactive (RR) rates obtained with the Antibody to HBsAg ELISA Test System 3 donor screening assay, with false repeat reactive results being confirmed using the Antibody to HBsAg ELISA Test System 3 Confirmatory Test. Ortho is currently examining available information as to the causes of these events. The letter recommended measures to mitigate problems with the donor screening assay, and provided changes made to the instructions for use of the Antibody to HBsAg ELISA Test System 3 Confirmatory Test kit.

[December 23, 2003 Letter - Ortho-Clinical Diagnostics Inc.] Adobe Acrobat [pdf] file

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