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The FDA has issued a public health advisory on the cholesterol-lowering drug Crestor (rosuvastatin calcium) to inform people about a possible risk of serious muscle damage from a condition called rhabdomyolysis that could occur with use of the drug. This advisory is part of an ongoing agency effort to provide people with earlier access to emerging safety information about their medicines so they can make more informed choices about their health care.
Extensive review of the available data indicates that patients taking recommended doses of Crestor have a similar risk of rhabdomyolysis as patients on other statin cholesterol treatments. Rhabdomyolysis is a rare but well-known side effect of all statins. Various types of kidney failure also have been reported in patients treated with Crestor, as well as other statins.
At the same time that the FDA issued the advisory, Crestor's manufacturer, AstraZeneca Pharmaceuticals of Wilmington, Del., revised the package insert for the drug, based on discussions with the agency. These changes re-emphasize recommendations made in the original label about the need for physicians to consider using lower starting doses of the drug in some individuals as a means of reducing the risk of rhabdomyolysis.
Overall, the FDA believes that the potential benefits of statin drugs when used as labeled and indicated for the treatment of elevated cholesterol outweigh their potential risks and provide an important treatment option for millions of Americans at risk for heart disease. The agency will continue to evaluate the scientific data on Crestor and other statin drugs and, when appropriate, will modify the particular drug's labeling.
The FDA has issued a public health advisory regarding Tysabri (natalizumab), a drug approved in November 2004 to reduce the frequency of multiple sclerosis (MS) attacks in people with relapsing forms of MS.
The drug manufacturer, Biogen Idec of Cambridge, Mass., voluntarily suspended marketing of Tysabri in February 2005 due to two serious adverse events reported with its use. Two confirmed cases, including one fatal, of progressive multifocal leukoencephalopathy (PML) in people receiving Tysabri for MS were reported to the FDA.
PML is a rare progressive nerve disease that can occur in people whose immune systems are suppressed. It often results in irreversible neurologic deterioration and death. Although the relationship between Tysabri and PML is not clear, because of the serious nature of PML, the FDA concurred with the manufacturer that it voluntarily withdraw the drug from marketing and suspend the use of Tysabri in clinical trials until more is known.
No previous cases of PML have been reported in the approximately 3,000 people who have taken Tysabri in clinical trials. The two serious adverse events occurred in people taking the drug in postmarketing studies required by the FDA. Both patients had been taking Tysabri for more than two years.
People being treated with Tysabri should discontinue its use and contact their physicians to discuss appropriate alternative treatments. The FDA is working with the manufacturer to determine the best methods for assessing people who have received Tysabri in order to assure their safety and understand the connection, if any, between Tysabri and PML. The FDA will provide further information as it becomes available.
In March 2005, the FDA approved Symlin (pramlintide acetate), an injectable medicine to control blood sugar for adults with type 1 and type 2 diabetes. Symlin is the only therapy for treating type 1 diabetes other than insulin. People with type 2 diabetes already have several other types of oral therapies available.
Symlin is to be used only in combination with insulin to help lower blood sugar during the three hours after meals. It is meant for patients who cannot achieve adequate blood sugar control on intensive insulin therapy alone. So-called "tight" control of blood sugar is desirable in all patients with diabetes to reduce the risk of blindness, kidney disease, vascular disease, and other long-term problems that diabetes can cause.
The safety and effectiveness of Symlin were studied in about 5,000 people. Side effects include nausea, vomiting, abdominal pain, headache, fatigue, and dizziness. Because of three areas of concern, there will be a medication guide and a risk minimization action plan for the use of Symlin. First, the principal risk is hypoglycemia, an abnormally low concentration of sugar in the blood. This risk is greatest in people with type 1 diabetes and people with slow stomach emptying (gastroparesis), a long-term complication of diabetes. Second, there is a potential for medication errors, specifically, mixing Symlin with insulin in the same syringe, which can alter the activity of the insulin. Finally, the potential for off-label use in people where the benefit-risk profile has not been characterized or demonstrated is also of concern and will be monitored by the sponsor.
Symlin has not been evaluated in children. The therapy should not be used if people cannot tell when their blood sugar is low, have gastroparesis, or are allergic to pramlintide acetate, metacresol, D-mannitol, acetic acid, or sodium acetate.
Symlin is manufactured by Amylin Pharmaceuticals Inc. of San Diego.
The FDA has approved the first generic version of Alza Corp.'s Duragesic Patch (fentanyl transdermal system). The approval, granted to Mylan Technologies Inc. of St. Albans, Vt., is expected to give patients a lower-cost alternative of this pain management system.
The patch is applied to the skin and delivers fentanyl, an opioid pain medication used to treat people with severe chronic pain that cannot be managed with alternative analgesics. The drug is slowly absorbed into the body, providing pain relief for up to three days.
The original fentanyl transdermal system was approved in 1990. It is approved for managing chronic pain in people who require continuous opioid analgesia for pain that can't be managed by acetaminophen-opioid combinations, non-steroidal analgesics, or as-needed dosing with short-acting opioids.
Fentanyl is a Schedule II controlled substance under the Controlled Substances Act, which is the highest level of control for drugs with a recognized medical use.
U.S. Surgeon General Richard H. Carmona warns that pregnant women and women who may become pregnant should abstain from alcohol to eliminate the chance of giving birth to a baby with the harmful effects of fetal alcohol spectrum disorders (FASD). This warning updates a 1981 Surgeon General's Advisory that suggested pregnant women should limit the amount of alcohol they drink.
A variety of birth defects caused by prenatal alcohol exposure comprise FASD. They may include mild and subtle changes, such as a slight learning disability or physical abnormality, through full-blown fetal alcohol syndrome (FAS), which can include severe learning disabilities, growth deficiencies, abnormal facial features, and central nervous system disorders.
Researchers first recognized FAS in 1973. The discovery led to widespread public education and awareness initiatives informing women to limit the amount of alcohol they consume while pregnant.
"We do not know what, if any, amount of alcohol is safe," says Carmona. "But we do know that the risk of a baby being born with any of the fetal alcohol spectrum disorders increases with the amount of alcohol a pregnant woman drinks, as does the likely severity of the condition." When a pregnant woman drinks alcohol, so does her baby, according to Carmona.
Studies indicate that a baby could be affected by alcohol consumption within the earliest weeks after conception, even before a woman knows she is pregnant, the surgeon general says. For that reason, the warning to abstain from alcohol includes women who may become pregnant.
A number of resources are available to assist health care and social services professionals in advising their patients to refrain from drinking alcohol during pregnancy. These can be found at:
Following an FDA investigation, U.S. Marshals seized $13,500 worth of two adulterated and misbranded dietary supplements that contained ephedrine alkaloids from a company in western Pennsylvania.
The products seized in February 2005 included specific lots of SciFit Procut and Thermogen II located at ATF Fitness Products Inc. in Oakmont, Pa.
FDA investigators determined that the seized products either contained prohibited ephedrine alkaloids or claimed to contain ephedrine or ephedrine alkaloids but did not. Alkaloids are a class of compounds derived from plants that can have potent pharmacologic effects.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA may remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use when there are no recommendations in the labeling. In February 2004, the FDA made such a finding for dietary supplements containing ephedrine alkaloids, and in April 2004, the agency published a final rule that prohibited their sale.
The FD&C Act also prohibits firms from marketing dietary supplements that are misbranded; that is, containing label information that is false or misleading, such as claiming to contain ingredients that are not actually present.
In response to ongoing concerns about manufacturing quality, the FDA and the Department of Justice recently seized some lots of Paxil CR (paroxetine) and Avandamet (metformin/rosiglitazone) tablets. Both drugs are manufactured by GlaxoSmithKline Inc. (GSK) of Research Triangle Park, N.C.
Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and type 2 diabetes (Avandamet), failed to meet the standards laid out by the FDA that ensure product safety, strength, quality, and purity.
"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," says John M. Taylor, FDA associate commissioner for regulatory affairs. "American consumers deserve the best health care products on the market today, and companies that are not adhering to these standards cannot assure FDA and American consumers of the quality of their products."
The FDA is not aware of any harm to consumers by the products subject to this seizure and it does not believe that these products pose a significant health hazard to consumers. The agency urges people who use these two drugs to continue taking their tablets and to talk with their health care provider about possible alternative products for use until the manufacturing problems have been corrected.
Among the violations noted during the FDA's latest inspection of GSK's manufacturing practices was the finding that the Paxil CR tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient. Additionally, the FDA found that some Avandamet tablets did not have an accurate dose of an active ingredient in this product.
The FDA is warning consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by a Canadian company, Globus Media of Montreal. The use of these products could result in false results, according to the FDA.
The following were listed as illegal:
The FDA has not approved or evaluated the performance of any of Globus Media's products, and consumers cannot know with any degree of certainty that test results from these kits are accurate. For example, a person who is not infected with HIV, the virus that causes AIDS, may test positive for HIV using one of these tests. And worse, someone infected with HIV may test negative and not seek medical treatment and could spread the virus to others.
The kits have been offered for sale on several Web sites, including www.htkit.com and www.hstkits.com. The kits usually are delivered overnight with instructions inside the packaging. The name of the kit appears on the instructions, although the manufacturer, packer or distributor may not be accurately identified.
Anyone who has used one of these test kits should be retested using valid test methods.
Only one HIV home collection test system is approved by the FDA and legally sold in the United States as either The Home Access HIV-1 Test System or The Home Access Express HIV-1 Test System. This kit is manufactured by Home Access Health Corp. of Hoffman Estates, Ill. No home-use test kits intended for diagnosing syphilis and dengue fever are approved for sale in the United States.
In March 2005, the FDA issued a public health advisory about the potential cancer risk associated with Elidel (pimecrolimus) and Protopic (tacrolimus). Both products are applied to the skin to control eczema by suppressing the immune system.
The FDA advised health care professionals to prescribe Elidel and Protopic only as directed and only after other eczema treatments have failed. The agency is also adding a "black box" warning to the professional labeling for the products and is developing a medication guide for patients.
These actions follow recommendations made by the FDA's Pediatric Advisory Committee during its Feb. 15, 2005, meeting. At this meeting, findings of cancer in three different animal species were reviewed. The data showed that the risk of cancer increased as the amount of the drug given increased. The data also included a small number of reports of cancers in children and adults treated with Elidel or Protopic.
The manufacturers of the products have agreed to conduct research on whether there is an actual risk of cancer in humans. The FDA advises physicians to weigh the risks and benefits of these drugs and to consider the following about Elidel and Protopic:
The FDA has approved the first intravenous human plasma-derived product to treat rare complications of smallpox vaccination.
Vaccinia Immune Globulin Intravenous (Human) (VIGIV) is made from the pooled plasma of donors who received booster immunizations with the licensed smallpox vaccine Dryvax. This plasma contains increased levels of protective antibodies against the vaccinia virus, the live virus used in the smallpox vaccine. The vaccinia virus does not cause smallpox.
Because the smallpox vaccine is made with this live virus--even though it is a weakened virus--it can occasionally cause infections in susceptible vaccinated people or those in close contact with them. People with weakened immune systems or certain skin conditions, such as eczema, are susceptible to vaccine complications. The most common side effects from the smallpox vaccine, such as a sore arm, fever, and body rashes, are self-limiting and do not require treatment. VIGIV would be used only for rare, serious vaccine complications, such as severe skin infection.