- Tamiflu (oseltamivir phosphate) Capsules
and for Oral Suspension
- Audience: Pediatricians, Primary Care
Providers, and other Healthcare professionals
Roche Laboratories and FDA notified healthcare professionals
of new preclinical safety data that have implications for the
use of Tamiflu in very young children. Preclinical findings in
juvenile rats have raised concerns regarding the use of Tamiflu
in infants less than 1 year of age. A single dose of 1000 mg/kg
oseltamivir phosphate (about 250 times the recommended dose in
children) in 7-day-old rats resulted in deaths associated with
levels of oseltamivir phosphate in the brain approximately 1500
times those seen in adult animals. It is likely that these high
exposures are related to an immature blood-brain barrier. The
clinical significance of these preclinical data to human infants
is uncertain. Given the uncertainty in predicting the exposures
in infants with immature blood-brain barriers, it is recommended
that Tamiflu not be administered to children younger than 1 year.
[December 2003 Letter - Roche
Pharmaceuticals] ![Adobe Acrobat [pdf] file](/peth04/20041108204457im_/http://www.fda.gov/medwatch/images/pdf.gif)
[October 2001 Package Insert -
Roche Pharmaceuticals]
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- Topamax (topiramate) Tablets/Sprinkle
Capsules
- Audience: Neurologists and other Healthcare
professionals
Ortho-McNeil and FDA revised the WARNINGS and PRECAUTIONS sections
of the prescribing information, notifying healthcare professionals
that Topamax causes hyperchloremic, non-anion gap metabolic acidosis
(decreased serum
bicarbonate). Measurement of baseline and periodic serum bicarbonate
during topiramate treatment is recommended.
[December 2003 Letter - Ortho-McNeil]
[December 2003 Full, revised
label, highlighted - Ortho-McNeil]
Previous MedWatch alert
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- Hospital Bed Fires
- Audience: Hospital risk managers
and administrators
The FDA Center for Devices and Radiological Health issued
a Public Health Notification with information on reports
of fires involving electrically powered hospital beds since
1993. The notification includes a list of safety tips. The
safety tips apply to both electrically powered and manual
healthcare beds, and to adjustable medical beds. They may
be particularly useful for older model beds. One list is
intended for the clinical staff and the other for staff responsible
for bed maintenance.
[December 18, 2003 Public
Health Notification -
FDA]
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- Permax (pergolide mesylate)
- Audience: Neurological and other
healthcare professionals
FDA and Lilly modified the WARNINGS and PRECAUTIONS sections
to inform healthcare professionals of the possibility of patients
falling asleep while performing daily activities, including
operation of motor vehicles, while receiving treatment with
Permax, a dopamine agonist, indicated
as adjunctive treatment to levodopa/carbidopa in the management
of the signs and symptoms of Parkinson's disease. Many patients
who have fallen asleep have perceived no warning of somnolence.
Healthcare professionals should be alerted to the potentially
serious risks associated with these events and should carefully
evaluate their patients for the presence of somnolence.
[December 15, 2003 Letter -
Eli Lilly]
[October 2003 Label, highlighted -
Eli Lilly]
Previous MedWatch alerts:
[February 2003 Letter - Lilly]
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- AneuRx Stent Graft System
- Audience: Interventional Radiologists,
Cardiovascular healthcare professionals and Risk Managers
The FDA Center for Devices and Radiological Health issued a Public Health Notification
with updated information on the mortality risks associated with the AneuRx Stent Graft System, when implanted for the prevention of abdominal aortic aneurysm rupture. This information was based on an analysis of the extension of an investigational premarket study, which began in March of 1996, with a subgroup of 942 patients followed
through October 24th, 2002. Based on the findings of the study, it was recommended that the AneuRx Stent
Graft be used only in patients who meet the appropriate risk-benefit profile
and who can be treated in accordance with the instructions for use.
[December 17, 2003 Public
Health Notification -
FDA]
Previous MedWatch alerts:
[April 30, 2001 Letter - FDA] PDF
Format
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- Acetaminophen,
Dixon's 325 mg Analgesic Tablets
- Audience: Pharmacists and consumers
Magno-Humphries, Inc., in cooperation with the FDA, voluntarily
recalled one lot (504 bottles) of Dixon's®, APAP Acetaminophen
325 mg Analgesic Tablets, an over-the-counter drug product
sold in 100 Tablet bottles with lot number 319687, Expiration
Date 03/05. The tablets contained in the mislabeled bottles
are 500 mg Acetaminophen, instead of 325 mg Acetaminophen.
Overdoses of acetaminophen can lead to severe health problems
including liver toxicity and liver failure. The acetaminophen
was sold under the Dixon's® label at retail stores and
pharmacies nationwide beginning in August 2003.
[December 4, 2003 Recall
Notice -
FDA]
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- ComfortGel Nasal Masks
- Audience: Hospital Risk Managers,
respiratory care professionals
The FDA Center for Devices and Radiological Health posted
a Class I recall notice for the ComfortGel Nasal Masks by
Respironics, Inc. Murrysville, PA. These masks are used on
patients being treated for obstructive sleep apnea or for
respiratory failure and are used in conjunction with CPAP
devices. These devices work by exhausting all of the exhaled
CO2 out of an exhalation port built into the mask.
The user instructions inform the patient that the mask contains
an exhalation port and does not require the use of a separate
exhalation device. However, the product was distributed without
the exhalation port. Without the port in the breathing circuit,
it is likely that the patient will experience increased CO2 re-breathing
and associated oxygen deficiency. In some cases, suffocation
may result.
[December 4, 2003 Device
Recall - FDA]
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- Arava (leflunomide)
- Audience: Rheumatoid specialists
and other healthcare professionals
Aventis Pharmaceuticals and FDA updated the prescribing information
for Arava (leflunomide),
indicated for the treatment of
active rheumatoid arthritis.
In postmarketing experience worldwide, rare, serious hepatic
injury, including cases with fatal
outcome, have been reported during treatment with Arava.
Most cases occurred within 6 months of
therapy and in a setting of multiple risk factors for hepatotoxicity.
Rare postmarketing reports of severe infections, including
sepsis, which may be fatal, were also
received. Most of the reports were confounded by concomitant
immunosuppressant therapy
and/or comorbid illness, which, in addition to rheumatoid
disease, may predispose patients to
infection.
[October, 2003 Letter -
Aventis]
[June, 2003 Revised, highlighted
label -
Aventis]
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- Ultane (sevoflurane)
- Audience: Anesthesia healthcare
professionals
Abbott Laboratories issued a "Dear Healthcare Professional" letter
concerning reports of fire or extreme heat in the
respiratory circuit of anesthesia machines when Ultane
is used in conjunction with a desiccated CO2 absorbent,
which can result in patient injury. Ultane
is indicated for induction and maintenance of general anesthesia
in adult and pediatric patients for inpatient and outpatient
surgery.
The letter provided suggestions to reduce the risk of occurrence of these adverse
events. Abbott, in collaboration with the FDA,
is investigating
the causative and preventive factors surrounding the issues
of fire, extreme heat,
and potential breakdown products associated with the use
of Ultane and desiccated CO2 absorbents.
[November 17, 2003 Letter -
Abbott]
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- PROLENE Polypropylene Mesh
- Audience: Surgeons, surgical staff,
hospital risk managers, and other healthcare professionals
(November 3, 2003) Ethicon, Inc. issued an alert about counterfeit polypropylene
mesh product labeled as PROLENE. PROLENE mesh is a nonabsorbable mesh used in
the repair of hernias and other fascial deficiencies. Physicians, nurses and
all other healthcare professionals should carefully examine all PROLENE flat
mesh product and not use any product that is suspected to be counterfeit. Ethicon
issued photo comparisons of authentic vs counterfeit Prolene product.
[UPDATED December 19, 2003 and May 7, 2004 Public
Health Web Notification - FDA]
[November 3, 2003 Letter - Ethicon]
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CYPHER Sirolimus-Eluting Coronary Stent
- Audience: Cardiology healthcare
professionals
(October 29, 2003) FDA issued a
FDA Public Health Web Notification to inform healthcare professionals
of sub-acute thromboses (SAT) and hypersensitivity reactions
with use of the Cordis CYPHER Coronary
Stent.
As of October
20, 2003, FDA has received more than 290 reports (>260 US and >25 outside
US) involving sub-acute
thrombosis (SAT) associated with the CYPHER stent. More than 60 reports of
SATs were associated with patient death and the remaining reports were associated
with patient injury requiring medical or surgical intervention. FDA also received
more than 50 reports, including some deaths, that Cordis considers possible
hypersensitivity reactions. The symptoms reported include: pain, rash, respiratory
alterations, hives, itching, fever, and blood pressure changes.
[UPDATE November 25, 2003 Public
Health Web Notification -
FDA]
[October 29, 2003 Public
Health Web Notification - FDA]
[October 29, 2003 Talk Paper - FDA]
Previous MedWatch alerts:
[July 7, 2003 Letter
- Cordis Corporation]
[July 8, 2003 FDA
News - FDA]
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-
- Public Health
Advisory - Suicidality in Pediatric Patients Treated with
Antidepressants for Major Depressive Disorder
- Audience: Mental health professionals,
pediatricians, and other healthcare professionals
The FDA notified healthcare professionals of
reports of the occurrence of suicidality (both suicidal ideation and suicide
attempts) in clinical trials for various antidepressant drugs in pediatric patients
with major depressive disorder (MDD).
FDA has completed a preliminary review of such reports for 8 antidepressant
drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine,
sertraline, and venlafaxine) studied under the pediatric exclusivity provision,
and has determined that additional data and analysis, and also a public discussion
of available data, are needed. FDA plans to hold an advisory committee meeting
before the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee
of the Anti-Infective Drugs Advisory Committee on February 2, 2004.
[October 27, 2003 Public Health Advisory -
FDA]
[October 27, 2003 Talk
Paper -
FDA]
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- Misys Healthcare Systems laboratory information system software
- Audience: Clinical laboratory administrator
and risk managers
December 18, 2003: The
FDA Center for Devices and Radiological Health posted a Class
I recall notice for Misys Healthcare Systems laboratory information
system software, used to manage patient specimens in the
laboratory for the diagnosis and treatment of a patient.
Version 5.3 of the software has demonstrated a defect that could result when
the information system uses 3 specific functions together, i.e. Rapid Order,
Calculations, and Autofiling.
Use of the defective laboratory information system software could result in
the release of laboratory test reports without quality assurance validation
and without abnormal results flags for critical values and abnormal results.
October 22, 2003 (NOTE: The following paragraph
is outdated and incorrect, and has been replaced by the notice
above) The
FDA Center for Devices and Radiological Health posted a Class
I recall notice for Misys Healthcare Systems laboratory information
system software, used to manage patient specimens in the
laboratory for the diagnosis and treatment of a patient.
Versions 5.2, 5.23, and 5.3 of the software have demonstrated
a defect that could result in quality assurance information
not being included in the patient report. Use of the defective
laboratory information system software could allow the release
of potentially life-threatening results directly to patients
without quality assurance validation.
[Corrected December 18, 2003
Recall Notice -
FDA]
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- Valcyte (valganciclovir HCl tablets)
- Audience: Transplantation and other
healthcare professionals
FDA and Roche notified healthcare professionals of the findings
of an active comparator study of Valcyte and ganciclovir
in heart, liver, kidney, and kidney-pancreas transplant patients
at high risk for CMV disease. Based on those findings: (1)
Valcyte is indicated for the prevention of CMV disease in
kidney, heart, and kidney-pancreas transplant patients at
high risk, (2) Valcyte is not indicated for
use in liver transplant patients, and (3) The safety and
efficacy of Valcyte for the prevention of CMV disease in
other solid organ transplant patients, such as lung transplant
patients, have not been established.
[September 30, 2003 Letter -
Roche]
[September 2003 Revised label - Roche] PDF
Format
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- Viread (tenofovir disoproxil fumarate)
- Audience: Infectious Disease and other healthcare professionals
Gilead Sciences, Inc. notified healthcare professionals of a high rate
of early virologic failure and emergence of nucleoside reverse transcriptase
inhibitor (NRTI) resistance associated mutations observed in a clinical study
of HIV-infected treatment-naïve patients receiving a once-daily triple NRTI regimen containing didanosine
enteric coated beadlets (Videx EC, Bristol-Myers Squibb), lamivudine (Epivir, GlaxoSmithKline), and
tenofovir disoproxil fumarate (Viread, Gilead). Based on these results, Tenofovir DF in combination with didanosine and lamivudine is not recommended when considering a new treatment regimen for therapy-naïve or experienced patients with HIV infection.
Patients currently on this regimen should be considered for treatment modification.
[October 14, 2003 Letter -
Gilead Sciences] PDF
Format
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- Lariam (mefloquine hydrochloride)
- Audience: Pharmacists, infectious
disease specialists and consumers
FDA and Roche Laboratories notified healthcare professionals
of the introduction of the Lariam Medication Guide
(MedGuide). The Lariam MedGuide was developed in collaboration
with the FDA to help travelers better understand the risks of
malaria, the risks and benefits associated with taking Lariam
to prevent malaria, and the rare but potentially serious
psychiatric adverse events associated with use of the drug. As
required by law, a Lariam Medication Guide is supplied to patients
each time Lariam is dispensed. Patients should be instructed
to read the MedGuide when Lariam is received.
[September, 2003 Dear Healthcare
Professional Letter -
Roche] PDF
Format
[September, 2003 Dear Pharmacist
Letter -
Roche] PDF
Format
[September 30, 2003 Lariam
Medication Guide -
Roche Laboratories] PDF
Format
[August, 2003 Full,
revised label -
Roche] PDF
Format
[July 9, 2003 Press
Release - FDA]
Previous MedWatch alerts:
[September, 2002 Letter to Physicians - Roche] PDF or HTML format
[September, 2002 Letter to Pharmacists - Roche] PDF or HTML format
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- CoaguChek PT test strips
- Audience: Primary Care providers
and consumers
The FDA Center for Devices and Radiological Health posted a Class I recall notice for CoaguChek PT test strips, used by patients in the home and by professionals in medical settings to determine blood clotting time of patients taking anti-coagulants, and to diagnose some disease conditions. Some of the foil pouches in which the test strips are packaged were improperly sealed allowing moisture and air to enter the pouch. These products give false results when exposed to moisture for more than a few minutes.
[October 8, 2003 Recall
Notice - FDA]
[September 30, 2003 Office of
In Vitro Diagnostic Device Evaluation and Safety (OIVD) - FDA]
[September 30, 2003 Product
Recall Update for Health Professionals - Roche Diagnostics] PDF
Format
[September 30, 2003 Product
Recall Update for Patients - Roche Diagnostics] PDF Format
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- Keppra (levetiracetam) Tablets
and Oral Solution
- Audience: Pharmacists, Neurologists,
and other healthcare professionals
FDA and UCB Pharma advised healthcare professionals of
the risk of dispensing errors between KEPPRA (levetiracetam),
an antiepileptic, and KALETRA (lopinavir/ritonavir), an antiretroviral.
Patients with epilepsy who do not receive their antiepileptic
drug due to a dispensing error would be inadequately treated
and could experience serious consequences, including status epilepticus.
[September, 2003 Letter -
UCB Pharma] PDF
Format
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- Roxanol (morphine sulfate)
Concentrated Oral Solution
- Audience: Pharmacists
and other healthcare professionals
NOTE: A corrected "Dear Healthcare Professional" letter
was issued October 22, 2003.
Elan Pharmaceuticals issued a "Dear
Healthcare Professional"
October 6, 2003 reporting serious adverse events and deaths
resulting from accidental overdose of high concentration morphine
sulfate oral solutions. In most of these cases, morphine oral
solutions ordered in milligrams
(mg) were
mistakenly interchanged for milliliters (mL) of the product,
resulting in 20-fold overdoses. Procedures for proper ordering and
dispensing were included in the "Dear
Healthcare Professional" letter.
UPDATE
[October 22, 2003 Corrected Letter -
Elan Pharmaceuticals] PDF
Format
[June 13, 2003 Letter -
Elan Pharmaceuticals]
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- FD&C Blue No. 1 (Blue 1) in enteral feeding solutions
- Audience: Critical care specialists
and other healthcare professionals
FDA alerted healthcare professionals of several reports of toxicity,
including death, associated with the use of FD&C Blue No.
1 (Blue 1) in enteral feeding solutions. In these reports, Blue
1 was intended to help in the
detection and/or monitoring of pulmonary aspiration in patients
being fed by an enteral feeding tube. Reported episodes were
manifested by blue discoloration of the skin, urine, feces, or
serum and some were associated with serious complications such
as refractory hypotension, metabolic acidosis and death. Case
reports indicate that seriously ill patients, particularly those
with a likely increase in gut permeability (e.g., patients with
sepsis), may be at greater risk for these complications.
[Sept 29, 2003 Public
Health Advisory -
FDA]
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- VIDAS Chlamydia Assay (CHL)
for In-Vitro Diagnostic Use
- Audience: Clinical
Microbiologists, Hospital Laboratory Staff and Risk Managers
The FDA Center for Devices and Radiological Health posted a
Class I recall notice for this in-vitro diagnostic product, used
in the laboratory on specimens collected from either symptomatic
or asymptomatic patients
for the qualitative detection of Chlamydia infections. The recalling
firm is bioMerieux,
Durham, N.C. A raw material, bovine
serum albumin, contained in the VIDAS (CHL) reagent strip, is
causing an accelerated degradation
of the product’s performance and creating the potential
for false negative results to be reported. Continued use of the
defective assay could result in a moderate to high risk of serious
adverse health consequences or death.
[Sept 26, 2003 Recall
Notice -
FDA]
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- Prandin (repaglinide)
- Audience: Endocrinologists, pharmacists
and other healthcare providers
Novo Nordisk and FDA revised the PRECAUTIONS/Drug Interaction
section of the prescribing information to inform healthcare professionals
of a drug-drug interaction between repaglinide (PRANDIN), a short-acting
insulin secretagogue, and gemfibrozil (Lopid) a lipid-lowering
agent used to treat dyslipidemia.
A study that evaluated the co-administration of gemfibrozil
with PRANDIN in healthy subjects found a significant increase in repaglinide
blood levels. Concomitant use may result in enhanced and prolonged
blood glucose-lowering effects of repaglinide. For patients
already on PRANDIN and gemfibrozil, blood glucose levels should
be monitored and PRANDIN dose adjustment may be needed.
[Sept, 2003 Letter -
Novo Nordisk] PDF
Format
[August, 2003
Revised, highlighted label - Novo
Nordisk] PDF
Format
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- Orlaam (levomethadyl acetate
hydrochloride)
- Audience: Pharmacists and drug dependency
healthcare professionals
Roxane Laboratories, Inc. is discontinuing the sale and distribution
of ORLAAM, a synthetic opioid agonist solution indicated for
the management of opiate dependence, reserved as second-line
therapy for the treatment of opiate-addicted patients who fail
to show acceptable response to other adequate treatments for
opiate addiction. ORLAAM was removed from the European market
in March 2001 following reports of severe cardiac-related adverse
events, including QT interval prolongation, Torsades de Pointes
and cardiac arrest. Other first-line treatment options are available
for the management of opiate dependence, including methadone
and buprenorphine. Roxane extimates that the current inventory
of this product will be depleted by February 2004 and encouraged
healthcare providers to transfer patients to alternative treatments
as soon as possible prior to the product’s unavailability.
[Sept 2, 2003 Letter -
Roxane Laboratories, Inc]
Previous MedWatch alerts:
[April 19, 2001 Letter -
Roxane Laboratories, Inc] PDF
Format
[April 20, 2001 Talk
Paper - FDA]
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- ProbeTec ET Instrument
- Audience: Clinical Microbiologists,
Hospital Laboratory Staff and Risk Managers
The FDA Center for Devices and Radiological Health posted a
Class I recall notice for the ProbeTec ET Instrument, an
in-vitro diagnostic medical device used for the detection of
Chlamydia and gonorrhea in symptomatic and asymptomatic
patients. The recalling firm is Becton Dickinson of Sparks,
Maryland. A component of the in-vitro diagnostic device was
incorrectly installed causing false positive and false negative
results. Continued use of the defective instrument could result
in a moderate to high risk of serious adverse health
consequences, including death.[August 21, 2003
CDRH Recalls Page - FDA]
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- Reyataz (atazanavir sulfate)
- Audience: Infectious
Disease and other healthcare professionals
BMS and FDA notified clinicians caring for HIV-infected
patients of important new safety data concerning the coadministration
of Reyataz (atazanavir sulfate) and Viread (tenofovir disoproxil
fumarate.) Clinicians should use caution when administering unboosted Reyataz
with tenofovir DF. Unboosted Reyataz may be less effective due to decreased
atazanavir concentrations in patients taking Reyataz and tenofovir DF. As a
result the coadministration of unboosted Reyataz with tenofovir DF may lead
to loss or lack of virologic response and possible resistance to Reyataz.
[August 8, 2003 Letter - BMS]
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Zenapax (daclizumab)
- Audience: Transplantation healthcare
professionals
FDA and Roche revised the WARNINGS, PRECAUTIONS,
ADVERSE REACTIONS, and CLINICAL STUDIES
sections of the prescribing information to include important
new safety information describing the increased mortality
seen in a cardiac transplant study and other updated information
regarding hypersensitivity reactions. Other sections of the ZENAPAX
labeling impacted by the addition of the information from the cardiac
transplant study have also been revised.
[August 2003 Letter -
Roche]
[July 2003 Revised,
highlighted label -
Roche]
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Serevent Inhalation Aerosol (salmeterol
xinafoate)
Serevent
Diskus (salmeterol
xinafoate inhalation powder)
Advair Diskus (fluticasone propionate and salmeterol inhalation
powder)
- Audience: Pulmonary
specialists and other healthcare professionals
The FDA announced the addition
of new safety information and warnings to the labeling for
drug products that contain salmeterol, a long-acting bronchodilator
used to treat asthma and chronic obstructive pulmonary disease
(COPD). The
new labeling includes a boxed warning
about a small, but significant, increased risk of life-threatening
asthma episodes or asthma-related deaths observed in patients
taking salmeterol in a recently completed large U.S. safety
study.
[August 2003 Letter -
GlaxoSmithKline]
[August 14, 2003 Talk
Paper - FDA]
[August 2003 Revised label, Serevent -
GlaxoSmithKline]
[August 2003 Revised label,
Serevent Diskus - GlaxoSmithKline]
[August 2003 Revised label, Advair
Diskus - GlaxoSmithKline]
Previous MedWatch alerts
[January 23, 2003 MedWatch Safety Alert]
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Pyrazinamide plus Rifampin for Treatment of Latent
Tuberculosis Infection (LTBI)
- Audience: Infectious Disease
and other healthcare professionals
The Centers for Disease Control and Prevention (CDC) notified
healthcare professionals of revised recommendations against
the use of rifampin plus pyrazinamide for treatment of latent
tuberculosis infection, due to high rates of hospitalization
and death from liver injury associated with the combined use
of these drugs.
[August 8, 2003 Letter -
CDC]
[August 8, 2003 MMWR
Article - CDC]
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Ziagen (abacavir)
- Audience: Infectious Disease
and other healthcare professionals
GlaxoSmithKline (GSK) notified healthcare professionals of
a high rate of early virologic non-response observed in a GSK-sponsored
clinical study of therapy-naive adults with HIV infection receiving
once-daily three-drug combination therapy with lamivudine (Epivir,
GSK), abacavir (Ziagen, GSK) and tenofovir (Viread, TDF, Gilead
Sciences). Based on these results: Abacavir and lamivudine
in combination with tenofovir should not be used as a triple
antiretroviral therapy when considering a new treatment regimen
for naive or pre-treated patients.
[July, 2003 Letter -
GlaxoSmithKline] PDF Format
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Genotropin (somatropin [rDNA origin] for injection)
- Audience: Pediatricians, endocrinologists
and other healthcare professionals
Pharmacia and FDA revised the
CONTRAINDICATIONS
and WARNINGS sections of the prescribing information
for Genotropin, indicated for the long-term treatment of pediatric
patients who have growth failure. Fatalities have been reported
with the use of growth hormone in pediatric
patients with Prader-Willi syndrome with one or more of
the following risk factors: severe obesity, history of respiratory
impairment or sleep apnea, or unidentified respiratory infection.
Male patients with these factors may be at increased risk.
[May 30, 2003 Letter - Pharmacia]
[April 2003 Full, revised label - Pharmacia]
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Nortrel 7/7/7 - 28 Day Oral Contraceptive (norethindrone and ethinyl
estradiol tablets, USP)
- Audience: Pharmacists, reproductive
health professionals, and consumers
Barr Laboratories announced a voluntary recall of
3 lots of its Nortrel 7/7/7 – 28 day (norethindrone and
ethinyl estradiol tablets, USP) oral contraceptive product.
The recall involves Lot Numbers 290122001, 290122002 and 290122003
and is being implemented because two individuals notified the
company that the color-coded tablets in their product blister
cards were in an improper sequence. Any woman who has received
a Nortrel 7/7/7 – 28 day blister card with tablets in
the wrong sequence could be at an increased risk of pregnancy.
In addition, changes to the menstrual cycle, including delayed
bleeding, irregular bleeding or spotting, may occur.
[July 9, 2003 Press Release - Barr
Laboratories] PDF Format
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Topamax (topiramate) Tablets/Sprinkle Capsules
- Audience: Neurologists, Pediatricians,
and other Healthcare professionals
Ortho-McNeil and FDA revised the WARNINGS and PRECAUTIONS
sections of the prescribing information to provide updated information
about oligohidrosis (decreased sweating) and hyperthermia, which
have been reported in topiramate-treated patients. Oligohidrosis
and hyperthermia may have potentially serious sequelae, which
may be preventable by prompt recognition of symptoms and appropriate
treatment.
[July 9, 2003 Letter - Ortho-McNeil]
PDF Format
[June, 2003 Revised label - Ortho-McNeil]
PDF Format
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CYPHER Sirolimus-Eluting Coronary Stent
- Audience: Cardiologists
Cordis Corporation issued a letter to inform healthcare
professionals of a rare but potential risk of thrombosis associated
with the use of the CYPHER Sirolimus-Eluting Coronary Stent.
The letter provides clarification on the safe use of the product
in accordance with the scientific evidence that led to product
approval.
The CYPHER stent was approved in April 2003 for patients undergoing
angioplasty procedures. Since the product’s introduction
it is estimated that over 50,000 patients have received a CYPHER
stent. To date, FDA has received 47 Medical Device Reports (MDRs)
of stent thrombosis occurring at the time of implantation or
within a few days of implantation.
[July 7, 2003 Letter
- Cordis Corporation]
[July 8, 2003 FDA
News - FDA]
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Esprit Ventilator Model V1000
- Audience: Hospital Risk Managers,
respiratory care professionals
The FDA Center for Devices and Radiological Health
posted a Class I recall notice for the Esprit Ventilator Model
V1000 by Respironics California, Inc., of Carlsbad, California.
Material used to construct three check-valves in this ventilator
predisposed the valves to premature failure. There have been
two patient injuries resulting in partial or complete failure
to permit ventilation.
[July 2, 2003 Device
Recall - FDA]
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- Health Nutrition (RMA Labs) Viga or Viga for Women
Tablets
- Audience: Healthcare
professionals and consumers
Health Nutrition (RMA Labs) warned consumers not
to purchase or consume the products known as Viga or Viga for
Women Tablets. These products, which are being marketed as dietary
supplements, contain the unlabeled drug ingredient sildenafil,
which may pose possible serious health risks to some users.
Viga is sold in bottles of 30 tablets, and in packet of 4 tablets
(ten packets in one small box). VIGA for women is sold in bottle
of 20 tablets. Both products are distributed by Health Nutrition
(RMA Laboratories Inc) and sold without medical prescription.
The interaction between nitrates and sildenafil can result
in profound and life-threatening lowering of blood pressure.
The use of nitrates in any form is an absolute contraindication
for sildenafil users. The potential for this product to be
taken by unknowing nitrate users is real, since erectile dysfunction
is often a concurrent condition in patients with diabetes,
hypertension, hyperlipidemia, smokers and patients with ischemic
heart disease.
[June 24, 2003 Press
Release - Health Nutrition (RMA Labs)]
Previous related MedWatch alerts
-
Best Life Viga Tablets (Posted 5/29/2003)
Vinarol Tablets (Posted 4/9/2003)
-
Previous related FDA Alerts
-
FDA
Warns Consumers Against Taking Some NVE, Inc. Supplements
(June 20, 2003)
-
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-
-
Lipitor (atorvastatin)
- Audience: Pharmacists
and consumers
(May 23, 2003) FDA announced that Albers Medical
Distributors, Inc voluntary recalled 3 lots of 10 mg 90-count
bottles of the cholesterol-lowering drug Lipitor and is warning
healthcare providers and others that these three lots of counterfeit
Lipitor represent a potentially significant risk to consumers.
FDA's investigation into this matter is continuing.
(June 9, 2003) Albers expanded their original voluntary recall
to include all lots of Lipitor that Albers purchased, which
were packaged by Med-Pro.
[UPDATE June 9, 2003 - Press Release
- Albers Medical Distributors, Inc.] PDF
Format
[UPDATE June 3, 2003 - Talk
Paper - FDA]
[May 23, 2003 Talk
Paper - FDA]
[May 22, 2003 Press Release - Albers
Medical Distributors, Inc.]
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-
-
Viga Tablets (Best Life International)
- Audience: Healthcare
professionals and consumers
Best Life International warned consumers not to purchase
or consume the product known as Viga. This product, which is
being marketed as a dietary supplement, contains the unlabeled
drug ingredient sildenafil, which may pose possible serious
health risks to some users. Viga is sold in bottles of 30 tablets
which are distributed by Best Life International Inc. This product
is being promoted for increasing desire, confidence and sexual
performance. The product is sold without medical prescription.
The interaction between nitrates and sildenafil can result
in profound and life-threatening lowering of blood pressure.
The use of nitrates in any form is an absolute contraindication
for sildenafil users. The potential for this product to be
taken by unknowing nitrate users is real, since erectile dysfunction
is often a concurrent condition in patients with diabetes,
hypertension, hyperlipidemia, smokers and patients with ischemic
heart disease.
[May 23, 2003 Press Release - Best
Life International]
-
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-
-
Risperdal (risperidone)
- Audience: Neuropsychiatric
healthcare professionals
Janssen Pharmaceutica and FDA revised the WARNINGS
section of the prescribing information for Risperdal (risperidone),
indicated for the treatment of schizophrenia. Cerebrovascular
adverse events (e.g., stroke, transient ischemic attack), including
fatalities, were reported in patients in trials of risperidone
in elderly patients with dementia-related psychosis. In placebo-controlled
trials, there was a significantly higher incidence of cerebrovascular
adverse events in patients treated with risperidone compared
to patients treated with placebo. RISPERDAL has not been shown
to be safe or effective in the treatment of patients with dementia-related
psychosis.
[April 16, 2003 Letter - Janssen
Pharmaceutica]
[March, 2003 Full, revised label
- highlighted changes - Janssen Pharmaceutica] ![Adobe Acrobat [pdf] file](/peth04/20041108204457im_/http://www.fda.gov/medwatch/IMAGES/PDF.GIF)
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-
-
INTERGEL Adhesion Prevention Solution
- Audience: Gynecological
healthcare professionals
GYNECARE Worldwide (a Johnson & Johnson Company)
and FDA Center for Devices and Radiological Health (CDRH) announced
the voluntary market withdrawal of “GYNECARE INTERGEL
Adhesion Prevention Solution” from the global market and
are urging customers to immediately stop using this device.
Post-market reports include late-onset post-operative pain and
repeat surgeries following the onset of pain, non-infectious
foreign body reactions, and tissue adherence. In some patients
a residual material was observed during the repeat surgery.
This product has been distributed in the following countries;
Austria, Canada, Egypt, England, France, Germany, Greece, Ireland,
Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Republic
of Singapore, Saudi Arabia, Scotland, South Africa, Spain, Sweden,
Switzerland, United Arab Emirates and the United States.
[April 16, 2003 Statement - FDA /
CDRH]
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-
-
Vinarol Tablets
- Audience: Healthcare
professionals and consumers
Ultra Health Laboratories, Inc. and Bionate International,
Inc. warned consumers not to purchase or consume a product known
as Vinarol tablets, promoted for increasing desire, confidence
and sexual performance. This product, marketed as a dietary
supplement and sold over the counter as well as via the Internet,
contains the unlabeled prescription drug ingredient, sildenafil,
which may pose possible serious health risks to some users.
The interaction between nitrates and sildenafil can result in
profound and life-threatening lowering of blood pressure. The
use of nitrates in any form is an absolute contraindication
for sildenafil users. The potential for this product to be taken
by unknowing nitrate users is real, since erectile dysfunction
is often a concurrent condition in patients with diabetes, hypertension,
hyperlipidemia, smokers and patients with ischemic heart disease.
[April 4, 2003 Press Release - Ultra
Health Laboratories, Inc.]
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-
-
Lindane (gamma-hexachlorocyclohexane)
- Audience: Primary
Care providers, Pharmacists, and consumers
FDA issued a Public Health Advisory concerning the
use of topical formulations of Lindane Lotion and Lindane Shampoo
for the treatment of scabies and lice. A boxed warning emphasizes
that it is a second-line treatment, updates information about
its potential risks, especially in children and adults weighing
less than 110 pounds, and reminds practitioners that reapplication
of Lindane Lotion or Lindane Shampoo is not the appropriate
treatment, if itching continues after the single treatment.
A Medication Guide, designed to inform patients of the risks
of Lindane products and provide instructions for appropriate
use of the drugs, must now be dispensed by the pharmacist with
each new prescription.
[March 28, 2003 Public
Health Advisory - FDA]
[March 2003 Label
- Lindane Shampoo]
[March 2003 Label
- Lindane Lotion]
[March 2003 Medication
Guide - Lindane Shampoo]
[March 2003 Medication
Guide - Lindane Lotion]
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Medwatch
-
Procrit (epoetin alfa)
- Audience: Pharmacists
and Oncological healthcare professionals
FDA and Ortho Biotech Products alerted healthcare
providers and consumers about the existence of three lots of
counterfeit product labeled as Procrit (epoetin alfa):
P007645 - 40,000 units/mL, Expiration 10-2004
P004677 - 40,000 units/mL, Expiration 02-2004
P004839 - 40,000 units/mL, Expiration 02-2004
The counterfeit Procrit has been found to be contaminated with
bacteria and therefore represents a significant potential hazard
to consumers. FDA testing has demonstrated that some counterfeit
product contains no active ingredient.
[March 11, 2003 Press
Release - FDA]
[March 8, 2003 Letter - Ortho Biotech]
Past MedWatch alerts:
[June 6, 2002 Letter - Ortho
Biotech] PDF Format
[June 7, 2002 Update - Ortho
Biotech] PDF Format
[October 22, 2002 Update
- Ortho Biotech]
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-
-
Avonex (Interferon beta-1a)
- Audience: Neurologists
and other healthcare professionals
Biogen and FDA revised the WARNINGS, PRECAUTIONS,
ADVERSE REACTIONS, PATIENT INFORMATION, and CLINICAL STUDIES
sections of the prescribing information to include important
new safety information and a patient Medication Guide. Updated
safety information includes a cautionary note regarding use
in patients with depression and other severe psychiatric symptoms.
Post-marketing reports of depression, suicidal ideation and/or
development of new or worsening of pre-existing psychiatric
disorders, including psychosis, and reports of anaphylaxis,
pancytopenia, thrombocytopenia, autoimmune disorders of multiple
target organs, and hepatic injury manifesting itself as elevated
serum enzyme levels and hepatitis were added to the labeling.
An FDA-approved Patient Medication Guide, providing important
patient safety information and comprehensive instructions for
patient self-administration of Avonex, was added.
[March 7, 2003 Letter - Biogen] PDF
Format
[February 2003 Full
Revised Label - Biogen] PDF
Format
[February 2003 Medication
Guide - Biogen] PDF
Format
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-
Permax (pergolide mesylate)
- Audience: Neurologists
and other healthcare professionals
Lilly and FDA revised the WARNINGS section of the
prescribing information to inform healthcare professionals of
reports of cardiac valvulopathy involving one or more valves
in patients receiving Permax therapy.
[February 2003 Letter - Lilly]
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Rapamune (sirolimus)
- Audience: Transplantation
surgeons and other healthcare professionals
Wyeth, in cooperation with FDA, notified healthcare
professionals of post-marketing reports of bronchial anastomotic
dehiscence, including fatal cases, in lung transplant patients
treated with Rapamune in combination with tacrolimus and corticosteroids.
The safety and efficacy of Rapamune as immunosuppressive therapy
has not been established in lung transplant patients.
[February 2003 Letter - Wyeth] PDF
Format
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Serzone (nefazodone HCl)
- Audience: Neuropsychiatric
healthcare professionals and Pharmacists
Bristol-Myers Squibb notified healthcare professionals
of medication errors due to name confusion between Serzone,
indicated for the treatment of depression, and Seroquel, a product
of AstraZeneca, indicated for the treatment of schizophrenia.
The overlapping strengths (100 mg and 200 mg), the dosage form
(tablets), the dosing interval (BID), and the fact that these
two products are stocked close together in pharmacies were critical
in causing these medication errors.
[December 9, 2002 Letter -
Bristol-Myers Squibb] PDF
Format
Past MedWatch alerts:
[May 20, 2002 Letter - AstraZeneca]
(Seroquel alert)
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Serevent (salmeterol xinafoate)
- Audience: Pulmonary
specialists and other healthcare professionals
GlaxoSmithKline notified healthcare professionals
of important new safety information on use of Serevent in patients
with asthma. Recent findings from an interim analysis of a large
Serevent safety study have prompted further review of the potential
association between Serevent and rare, but potentially serious,
respiratory adverse events.
[January 23, 2003 Letter - FDA] PDF
Format
[January 23, 2003 Talk
Paper - FDA]
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Ancom Anti-Hypertensive Compound Tablets
- Audience: Pharmacists,
other healthcare professionals, and consumers
(January 17, 2003) Herbsland Inc. recalled all 100
tablet bottles of Ancom Anti-Hypertensive Compound Tablets,
an unapproved new drug labeled to contain several prescription
drug ingredients, including reserpine, diazepam, promethiazine,
and hydrochlorothiazide. The sale of a product with this combination
of ingredients poses possible serious health risks including
sedation, depression, and potentially life-threatening abnormalities
of the blood. This recall includes all lot codes of the product
remaining on the market. Ancom Tablets were sold without prescriptions
to consumers through distributors and retail stores located
in the New York City metropolitan area, specifically Manhattan,
Brooklyn, and Queens. Nationwide sales are also possible as
this product was sold via the Internet.
(UPDATE March 18, 2003) Ancom Tablets were sold without prescriptions
to consumers at Tai Chien's retail establishment in New York
City. Product was also sold to a distributor in Puerto Rico.
At least one illness has been reported to date.
[March 18, 2003 Press
Release - Tai Chien Inc.]
[January 17, 2003 Press
Release - Herbsland, Inc.]
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Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate
tablets)
Premarin (conjugated estrogens tablets, USP)
- Audience: Reproductive
healthcare professionals
FDA and Wyeth revised the prescribing information
to include a boxed warning, which states that estrogens and
estrogens plus progestin therapies should not be used for the
prevention of cardiovascular disease.
The boxed warning includes risk information from the Women's
Health Initiative (WHI) study. The study reported increased
risks of myocardial infarction, stroke, invasive breast cancer,
pulmonary emboli, and deep vein thrombosis in postmenopausal
women during 5 years of treatment with conjugated equine estrogens
(0.625 mg) combined with medroxyprogesterone acetate (2.5 mg)
relative to placebo. Because of these risks, estrogens with
or without progestins should be prescribed at the lowest effective
doses and for the shortest duration consistent with treatment
goals and risks for the individual woman.
[January 6,2003 Letter - Wyeth] PDF
Format
[January 2003 Prempro/Premphase Full
Revised Label - Wyeth]
[January 2003 Premarin Full Revised
Label - Wyeth]
[January 2003 Drug
Information Page - FDA/CDER]
Past MedWatch Alerts:
[August 2002 MedWatch
Safety Alert]
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