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The FDA is warning consumers that a product, Better Than Formula Ultra Infant Immune Booster 117, sold over the Internet as a dietary supplement, should not be fed to infants.
NSP Research Nutrition of Mt. Clemens, Mich., sells the product as a dietary supplement. However, as a result of its labeling claims, the FDA is concerned that the product may be used as an infant formula. The term "Better Than Formula" in the product name describes this product as a substitute for, or alternative to, other infant formulas.
In addition, the "mixing instructions and directions" printed on the label state, "As with adults, infants should have small feedings every 2 to 3 hours throughout the day and should never be overfed." This statement appears to represent the product for use as a meal and not as a dietary supplement. There are many other promotional claims that appear to describe this product as an infant formula.
Under the Federal Food, Drug, and Cosmetic Act, "infant formula" is a food that claims to be for special dietary use solely as a food for infants because it is suitable as a substitute for human milk. Better Than Formula Ultra Infant Immune Booster 117 has not been reviewed as an infant formula by the FDA. If it is used as an infant formula, there are no assurances that its nutritional value and safety as an infant formula are known. In addition, the label lists a number of ingredients that have not been evaluated for safe use in infant formula.
No illnesses or injuries to date have been reported to the agency, but consumers are advised to contact their health care providers if they have any concerns about possible health problems or illness of their babies.
The FDA has issued a final rule requiring that bar codes be placed on the labeling of most prescription drugs and certain over-the-counter drugs. The measure, issued in February 2004, is designed to support the widespread adoption of information systems that have reduced medication error rates by as much as 85 percent in some hospitals.
In hospitals currently using bar codes, patients receive a bar-coded identification bracelet. A health care professional scans the bar codes on the patient and on the drug. The information system then verifies that the right patient is getting the right drug at the right time, and in the right dose and method of administration.
In accordance with the FDA rule, each bar code must contain the drug's National Drug Code number, a unique 10-digit identifier for human drugs. The code indicates the product, its labeler, vendor, and the package size. Companies may also include information about lot numbers and expiration dates. The final rule applies to most drug manufacturers, repackers, relabelers, private label distributors, and blood establishments.
New medications covered by the rule are required to have bar codes within 60 days of their approval. Most products that were previously approved will have to comply with the new requirements within two years.
The FDA is warning the public not to consume Green Hornet or any other products that claim to provide "safe legal highs" or that are marketed as "street drug alternatives" by Cytotec Solutions Inc. of Tampa, Fla. Products by this company have been promoted and sold on the Internet and in stores as legal versions of illicit street drugs. The other products included in this warning are Trip2Night, Invigorate II, Snuffadelic, Liquid Speed, Solar Water, Orange Butterfly, and Schoomz. Although Cytotec Solutions is no longer producing these products, they remain under investigation and the FDA is working to identify and address additional distributors.
The liquid product called Green Hornet is marketed as an herbal version of the illegal street drug "Ecstasy."
The FDA recently became aware of reports of bad side effects experienced by four teen-agers after consuming Green Hornet. The product contained high levels of the drugs diphenhydramine and dextromethorphan, ingredients found individually in numerous over-the-counter cough and cold medicines. The teen-agers were rushed to a hospital emergency room after they experienced seizures, excessive heart rates, severe body rashes, and high blood pressure.
FDA analyses of additional products manufactured or distributed by Cytotec Solutions Inc. also have found the drug ephedrine and the controlled substances GBL and GHB.
The FDA considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug marketed in violation of the Federal Food, Drug, and Cosmetic Act. Also, any product containing undeclared active drug ingredients violates the law.
The FDA has issued draft guidance on developing drugs to treat the side effects of vaccination against smallpox, a disease caused by the variola virus.
Routine vaccination for smallpox in the United States ended in the 1970s when the disease stopped occurring naturally. But because smallpox is a potential agent of terrorism, large-scale vaccination could be necessary in an emergency.
The smallpox vaccine is made from a virus called vaccinia, a "pox"-type virus related to smallpox. It contains the "live" vaccinia virus--not dead virus, like many other vaccines. When given before exposure to variola virus, the live vaccinia vaccine substantially protects most people against smallpox for at least several years. Also, if given within a few days after initial exposure, the vaccine may prevent or lessen the impact of smallpox infection.
But the vaccine can cause serious complications, such as severe infection at the site of vaccination or other areas of the skin. The vaccine can also cause the virus to spread to other parts of the body or to other people. Other side effects of the vaccine include rashes, inflammation of the brain and heart, and smallpox infection of a fetus.
Groups at increased risk for complications include people with suppressed immunity, pregnant women, people with a history of eczema and other chronic skin diseases, and possibly people who have heart disease.
The FDA's draft guidance is available online.
The FDA has taken action against four foreign Internet sites found to be selling counterfeit contraceptive patches that provide no protection against pregnancy.
The sites are: www.rxpharmacy.ws, www.generic.com, www.usarxstore.com, and www.europeanrxpharmacy.com. These sites also sold other products that were purported to be the same as FDA-approved drugs, but none of these products should be considered safe or effective. The FDA is investigating these other products as well, and urges consumers who have bought any of these products not to use them and to contact their health care providers immediately.
The U.S.-based Internet service provider for these four sites cooperated with the FDA to shut down access to the sites. The FDA cannot be certain that no other Internet sites are selling the same counterfeit products.
The counterfeit contraceptive patches were promoted as Ortho Evra transdermal patches, which are FDA-approved and made by Ortho-McNeil Pharmaceutical Inc. of Raritan, N.J.
The FDA-approved patch is one and three-quarters inches square, made of a thin, beige-colored film, and comes packaged in a sealed, opaque, white pouch with the product label attached to one side of the pouch. The lot number and expiration date are printed on the attached label and on the back side of the pouch.
The counterfeit product is one and a half inches square, brown in color, made of woven material, and has five holes that appear as red dots on the middle of the top side of the patch. It also has an orange square resembling gauze under the plastic liner on the back side of the patch. The product comes in a resealable plastic bag without identifying materials, lot numbers, expiration date, or any other labeling information.
Photos contrasting the legitimate contraceptive patch with the counterfeit can be viewed on this Web site.
Consumers interested in buying safe and effective drugs online should only make purchases from sites that bear the Verified Internet Pharmacy Practice Sites (VIPPS) seal. Visit the VIPPS Web site for more information about the verification program and a list of reputable online pharmacies.
Cancer of the mesothelium--a membrane that covers and protects most of the body's internal organs--is usually associated with a history of asbestos exposure and affects the lining of the chest. About 2,000 new cases are diagnosed each year. By the time symptoms appear, the disease is often advanced, with people living nine to 13 months on average after diagnosis.
In February 2004, the FDA approved Alimta (pemetrexed), the first drug for a rare type of cancer called malignant pleural mesothelioma.
Alimta works by blocking enzymes thought to play a role in the rapid growth of lung tumors. The drug received a priority review and was approved for use with another cancer treatment called cisplatin. In a clinical trial, people receiving Alimta and cisplatin lived three months longer than those given cisplatin alone (12 months versus nine months). Alimta must be given with vitamin B-12 and folic acid to lower the chance and the severity of side effects.
The most common side effects are low white blood count, nausea, vomiting, fatigue, rash, and diarrhea.
Alimta will be distributed by Eli Lilly and Company of Indianapolis.
Adults and children who take antidepressants should be monitored for worsening depression and thoughts of suicide--especially at the beginning of treatment or when doses are changed, the FDA says.
In March 2004, the agency asked drug manufacturers to strengthen warnings on the labels of 10 drugs: Wellbutrin (bupropion), Celexa (citalopram), Prozac (fluoxetine), Luvox (fluvoxamine), Remeron (mirtazapine), Serzone (nefazodone), Paxil (paroxetine), Zoloft (sertraline), Lexapro (escitalopram), and Effexor (venlafaxine).
The FDA has been closely reviewing the results of antidepressant studies. Although it is not yet clear whether antidepressants contribute to suicidal thinking and behavior, the FDA is advising health care providers that worsening symptoms could be due either to the underlying disease or to drug therapy.
Health care providers, caregivers, patients, and their families should also be alert for certain behaviors associated with antidepressants, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, and mood disorders marked by agitation, excitability, or elation (hypomania and mania). Physicians should be particularly vigilant when treating people who have bipolar disorder.
The public health advisory containing the new label warnings is available online.
Canada, Mexico, and the United States have finalized an agreement to increase communication, collaboration, and the exchange of information in the areas of drugs, biologics, medical devices, food safety, and nutrition. The three countries have signed the Trilateral Cooperation Charter, a document that describes how they will work together more closely to protect and promote the public health of all people in North America.
"Advancing and protecting the public health is this agency's mission," said former FDA Commissioner Mark B. McClellan, M.D., Ph.D. "[The] agreement is the culmination of years of hard work with our colleagues from Canada and Mexico, and ... demonstrates our mutual dedication toward achieving that goal on our shared continent."
The charter serves the mutual interests of all three countries and provides a forum and a framework for participants to discuss effective means for achieving their shared public health mission.
The charter lists key priorities for cooperation among the three countries in 2004. These include enforcement actions against fraudulent weight-loss products and other health fraud cases, better emergency response and preparedness for public health emergencies, and coordinating the work of analytical laboratories that support investigations of fraudulent or counterfeit products and other public health risks.
The new charter took effect on Feb. 27, 2004, and is available online.
The FDA has approved a miniaturized heart pump for children ages 5 to 16 who are awaiting a heart transplant. While similar devices have been approved for use in adults, this is the first one to be approved for use in children.
The DeBakey VAD Child, a ventricular assist device, was approved in February 2004 under the humanitarian device exemption (HDE), which makes devices available on a limited basis for patients with rare medical conditions. The device is designed to help the left ventricle of the heart pump blood. Use of the device may allow children with severe left ventricle failure to survive long enough to receive a heart transplant.
An HDE is a special regulatory marketing approval available for medical devices to treat conditions that affect fewer than 4,000 people annually in the United States. It is estimated that fewer than 100 children a year will be candidates for the new device.
The device is manufactured by MicroMed Technology Inc. of Houston.
A new Department of Health and Human Services Task Force on Drug Importation will help determine how drugs might be imported safely and will examine the potential impact on the health of Americans, on medical costs, and on the development of new medicines.
The task force, announced by HHS Secretary Tommy G. Thompson in February 2004, will collect information from a wide variety of health care interests, including supporters and opponents of importation. The task force will then offer recommendations to Thompson on how best to address questions posed by Congress on drug importation. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 directed HHS to complete a comprehensive study of importation by December 2004.
Thompson named Surgeon General Richard H. Carmona, M.D., M.P.H., to serve as the task force's chairman. "Under Dr. Carmona's leadership, this task force will fully examine the issues surrounding drug importation to determine how to assure consumers that such imported drugs are safe and effective," Thompson said. "We haven't been able to provide those safety assurances as required by law and with available resources. The task force will study if drugs can be imported safely and, if so, what resources would be needed to ensure safety."
Twelve additional members of the task force include representatives with knowledge or involvement in drug importation issues from across HHS, as well as from other parts of the federal government. The FDA is represented on the task force by Acting FDA Commissioner Dr. Lester M. Crawford and Amit K. Sachdev, acting deputy commissioner for policy.
The task force schedule includes five meetings, one each with representatives from consumer groups; professional health care providers; health care purchasers, including representatives of cities and states; industry representatives; and international stakeholders. Additionally, the schedule includes an opportunity for the general public to comment.
A public docket, 2004N-0115, to accept comments for the record is available on this Web site.
Patients who experience debilitating consequences of chronic kidney disease and parathyroid cancer now have a first-of-its-kind treatment option.
Sensipar (cinacalcet) was approved in March 2004 to treat secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. In secondary hyperparathyroidism, elevated levels of parathyroid hormone are associated with changes in calcium and phosphorus metabolism, bone pain, fractures, and an increased risk for cardiovascular death.
The drug also was approved to treat hypercalcemia, an elevation in calcium levels in the blood, that results from a rare cancer of the parathyroid glands. Elevated levels of serum calcium can cause mental confusion, lethargy, dehydration, nausea, vomiting, constipation, and kidney damage.
Nearly all of the more than 300,000 kidney dialysis patients in the United States experience hyperparathyroidism.
Treatment with Sensipar, manufactured by Amgen Inc. of Thousand Oaks, Calif., lowers blood levels of parathyroid hormone as well as the amount of calcium and phosphorus in the blood.
The FDA has announced that Moving Solutions Inc. of Downers Grove, Ill., is recalling its patient lifts because of a faulty design. Patient lifts are mechanical sling-like devices used in hospitals and nursing homes to move people from one place to another, as from a bed to a bath.
Excessive wear of the main bolt of Moving Solutions' lift causes the bolt to break. When that happens, the lift arm is no longer secured to the lift, and the patient will fall. The lift arm could also fall on the patient, which could result in serious injury and even death. The FDA has received one report of a death related to the failure of the bolt.
This recall involves all FAABORG model battery-operated patient lifts distributed by Moving Solutions. Some 856 lifts have been distributed throughout the United States. Facilities should stop using these lifts until the problem is corrected.
FAABORG, located in Denmark, is the manufacturer. Moving Solutions is the initial U.S. distributor, though there may be other distributors.
Former FDA Commissioner Mark B. McClellan, M.D., Ph.D., is the new administrator of the Centers for Medicare & Medicaid Services (CMS) at the Department of Health and Human Services.
Dr. Lester M. Crawford has been named acting FDA commissioner.
McClellan became the 18th Commissioner of Food and Drugs in November 2002. A native of Austin, Texas, McClellan was a professor, physician, and health care economist at Stanford University before moving to Washington, D.C., in 1998 to work in the Clinton administration.
McClellan, who became Medicare administrator on March 25, 2004, received his medical degree from the Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology in 1992. He received a doctorate in economics from MIT a year later.
McClellan replaces Thomas Scully, who resigned in December 2003.