|
|
|
FDA Home Page | Search
FDA Site | FDA A-Z Index | Contact
FDA
Topics in This Issue:
Restylane (hyaluronic acid), approved by the FDA in December 2003, is the third injectable product available to treat facial wrinkles. Restylane is different than the other approved products in that its effects last longer, about six months.
Studies showed that Restylane, classified as a medical device by the FDA, is safe and effective for filling moderate-to-severe wrinkles around the nose and mouth. Most people needed one injection to get optimal correction, while about one-third of people tested needed more than one injection to get a satisfactory result.
The two other injectable products approved by the FDA are collagen injections for correcting soft tissue deficiencies such as wrinkles and acne scars, and botulinum toxin (Botox Cosmetic) for treating frown lines between the eyebrows. The effects of both treatments last as long as four months.
Restylane is manufactured by Q-Med AB of Uppsala, Sweden.
Health care professionals have been alerted by the FDA to watch out for a counterfeit product labeled as Prolene polypropylene mesh, which is used in hernia repair and other surgery. The authentic Prolene mesh is manufactured by Ethicon Inc. of Somerville, N.J.
Preliminary testing of the counterfeit Prolene indicates that some samples are not sterile. Although the FDA has not received reports of excess infections with the counterfeit product, the agency is concerned about its sterility.
The FDA continues to test the material and is investigating whether the product is being marketed. In the meantime, the agency recommends that health care professionals carefully examine all polypropylene mesh products and not use any suspected of being counterfeit. The counterfeit mesh is labeled with lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07). It can be further identified by one of the following:
View the "Public Health Notification on Counterfeit Polypropylene Mesh."
Since 1993, the FDA has received 95 reports of fires that involved electrically powered hospital beds. The agency has prepared a list of safety tips for hospitals and other medical facilities to help prevent such fires.
The majority of the reports involved fires ignited by such causes as the overheating of the bed motor or capacitors, arcing at the plug and wall plate, and missing components in the wiring of the bed. The remaining reports identified smoke or flames that came from the bed, but no conclusion was reached as to the cause of the fire. Smoking in bed was the cause of one fire reported to the FDA.
The safety tips, released in December 2003, apply to both electrically powered and manual health care beds and to adjustable medical beds. One list of tips is for clinical staff and another list is for mechanical maintenance staff.
The FDA is seeking additional information on fires involving hospital beds. Some medical facilities are required to report problems with medical devices, including hospital beds, to the FDA. Health care providers employed by these facilities should use their established procedures for reporting hospital bed fires to the agency. All other health care providers may submit their reports to MedWatch, the FDA's voluntary reporting program.
The reports can be submitted by phone at (800) FDA-1088; by fax at (800) FDA-0178; by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or to MedWatch online.
Two tests approved by the FDA in December 2003 will help identify people with an increased risk of developing blood clots in their legs and elsewhere. The tests--called Factor V Leiden kit and Factor II (prothrombin) G20210A--identify hereditary abnormalities in two proteins involved in blood clotting. Five to 10 percent of Americans have at least one of these genetic abnormalities. Left untreated, blood clots can cause death.
To do the tests, millions of identical copies of a person's Factor V or Factor II gene segment are made using a process called polymerase chain reaction (PCR). A fluorescent tag then binds to the DNA and is used to measure the presence or absence of the clotting mutation.
The tests represent a significant advance in technology. The FDA has cleared other genetic tests in the past, but these are the first tests that are specific for these particular mutations.
The DNA-based tests are manufactured by Roche Diagnostics Corp. of Indianapolis.
The FDA can now require certain research that will improve the quality of health care for children. This authority was granted to the agency under a new law known as the Pediatric Research Equity Act. Signed by President Bush in December 2003, the law allows the FDA to require drug firms to conduct pediatric studies of drugs when needed to ensure that the drugs are safe and effective when used in children.
"The Pediatric Research Equity Act of 2003 will allow FDA to close the knowledge gap when it comes to treating children," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. "FDA will now have clear authority to require pediatric studies of drugs when other approaches are not sufficient to ensure that drugs are safe and effective for children."
Prior to the act, studies of drug effects in children were done infrequently, and doctors had to rely on adult test results when prescribing drugs to children.
"Prescription drugs can do more than ever to cure diseases, including illnesses in children," says McClellan. "But it is not good medicine to assume that children can be treated like little adults. Parents and health professionals deserve confidence that medicines used to treat children are safe and effective. FDA will use this important new law to require pediatric studies, when necessary, to give parents and doctors the confidence they deserve."
A first-of-its-kind tablet is the latest addition to the selection of oral contraceptives available to women. Ovcon 35, approved by the FDA in November 2003, is a spearmint-flavored tablet that can be chewed or swallowed whole.
Ovcon 35 contains a progestin (norethindrone) and an estrogen (ethinyl estradiol), ingredients found in contraceptive products that are already marketed. Directions for use tell women that if the pill is chewed and then swallowed, they should drink an 8-ounce glass of liquid immediately afterwards so that the full dose of medication reaches the stomach and no residue is left in the mouth.
Risks associated with Ovcon 35, manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., are similar to those of all birth control pills and include an increased risk of blood clots, heart attack, and stroke. The product labeling also warns that cigarette smoking by women, especially those older than 35, increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.
Men with advanced cases of prostate cancer now have an additional treatment option. In November 2003, the FDA approved Plenaxis (abarelix), a drug given as an injection. Plenaxis lowers the male hormone testosterone, a key factor involved in most prostate cancer growth.
Because of an increased risk of serious and potentially life-threatening allergic reactions, use of Plenaxis is restricted to advanced prostate cancer patients who have no alternative therapy. The drug is distributed directly to physicians and hospital pharmacies enrolled in a risk management program. Plenaxis is not distributed through retail pharmacies.
The effectiveness of Plenaxis in lowering testosterone production was demonstrated in a study of 81 men with advanced prostate cancer. The study showed that the men could avoid surgical castration by undergoing at least 12 weeks of treatment. Some men also experienced other benefits, such as decreased pain. But three of the men experienced serious allergic reactions, one of which included loss of consciousness.
Because of the risk of low blood pressure and fainting as part of the allergic reaction, men being treated with Plenaxis should be monitored for at least 30 minutes after receiving a dose of the drug in their health provider's office. The most common side effects of Plenaxis are hot flashes, sleep disturbances, back pain, breast enlargement or pain, and constipation.
Plenaxis is marketed by Praecis Pharmaceuticals Inc. of Waltham, Mass.
A draft FDA guidance document released in January 2004 should give those seeking marketing approval for breast implants--particularly those filled with silicone gel--a better understanding of the information that should be provided for the FDA to evaluate the safety and effectiveness of these medical devices. The guidance document includes modified recommendations for mechanical testing, determining modes and causes of rupture, clinical studies, post-approval requirements, and labeling.
"This revised guidance is our view on the information needed to provide a reasonable assurance of safety and to allow women and physicians to make informed decisions about silicone implants," says Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs.
The January guidance document updates a previous version published in February 2003, which has been useful to sponsors and the FDA in preparing and reviewing premarket approval applications. By updating the document, the FDA is more clearly identifying the type and amount of scientific data that will allow the FDA to evaluate whether these products are safe and effective.
Joseph A. Levitt, J.D., retired from the FDA on Dec. 31, 2003, after serving as director of the agency's Center for Food Safety and Applied Nutrition (CFSAN) for six years. Robert E. Brackett, Ph.D., was appointed director, effective Jan. 1, 2004.
"As a staff attorney, Commissioner's chief of staff, deputy center director, and center director, Joe has clearly had a unique and lasting impact on the health of Americans," FDA Commissioner Mark B. McClellan, M.D., Ph.D., said in announcing the change. "With a career-long commitment to improving America's health and strengthening FDA, Joe leaves our food and nutrition center as a world-class organization, ready to meet the challenges ahead."
Brackett was recruited to the FDA in 2000 and has been crucial to strengthening CFSAN's scientific expertise in food safety and counterterrorism. "As our food and nutrition center faces more challenges and responsibilities than ever--as well as better science to meet them--FDA is indeed fortunate to be able to call upon Dr. Bob Brackett," McClellan added.