The agency considers the products to be drugs because their names reflect that they are intended for the same use as the anti-obesity drugs fenfluramine and phentermine, which in combination are commonly referred to as "fen-phen."
FDA warned consumers last November about "herbal fen-phen." The agency believed that an increase in use of these alternative products might follow from the September withdrawal based on safety concerns about fenfluramine (Pondimin) and another prescription anti-obesity drug, dexfenfluramine (Redux). In addition, promotion of these products over the Internet and through weight-loss clinics, print ads, and retail outlets is on the rise.
The main ingredient in most herbal fen-phen products is ephedra, also called Ma Huang. Ephedra is an amphetamine-like compound with potentially powerful stimulant effects on the nervous system and heart. Since 1994, FDA has received more than 800 reports of adverse events associated with ephedrine alkaloid-containing products, ranging from high blood pressure and headaches to heart attacks and death.
Many ephedra-containing herbal fen-phen products also contain Hypericum perforatum, often called St. John's Wort or "herbal Prozac," which has not been studied under carefully controlled trials.
Other herbal fen-phen products contain 5-hydroxy-tryptophan. This compound is closely related to L-tryptophan, which was pulled from the market after being linked to 1,500 cases, including about 38 deaths, of a rare blood disorder.
Labels also must identify these products as dietary supplements (for example, "Vitamin C Supplement") and when products have botanical ingredients, the part of the plant used must be identified, according to final FDA rules in the Sept. 23, 1997, Federal Register.
The rules, which take effect March 23, 1999, will implement several key provisions of the Dietary Supplement Health and Education Act of 1994.
The Supplement Facts panel must provide information about:
"High potency" will be allowed to describe both individual vitamins and minerals or multinutrient products. When describing an individual vitamin or mineral, it will mean that 100 percent or more of the Daily Value for the nutrient is present in each serving. For multinutrient products, it will mean that one serving provides more than 100 percent of the Daily Value for two-thirds of the vitamins and minerals present.
"Antioxidant" may be used with the already defined claims "good source of" and "high" to describe a nutrient for which a Reference Daily Intake value has been established (for example, vitamin C) and the nutrient is shown by scientific evidence to inactivate free radicals or to prevent free-radical-initiated chemical reactions in the body after a sufficient quantity of the nutrient has been absorbed.
The hypertension drug, Posicor (mibefradil dihydrochloride), joins antibiotics such as erythromycin and antifungals such as ketoconazole, which have long been associated with severe risks when taken with Seldane, Seldane-D, or generic versions containing the antihistamine terfenadine.
The new labeling also warns against taking the antihistamine at the same time as these drugs:
FDA is in the process of removing all terfenadine products from the market because of the approval of a safer alternative, Allegra (fexofenadine hydrochloride). (See "Antihistamine Poses Possible Safety Risk" in the Updates section of the April 1997 FDA Consumer.) Both Allegra and Seldane are manufactured by Hoechst Marion Roussel Inc.
FDA urges health-care providers to report any terfenadine-related adverse events to the manufacturer by calling 1-800-633-1610 or to FDA's MedWatch program by calling 1-800-FDA-1088.
Under the Mammography Quality Standards Act of 1992, FDA has strengthened the interim rules by which it has certified and inspected almost all 10,000 U.S. mammography facilities. According to the final rules:
To obtain names and locations of FDA-certified facilities, call the Cancer Information Service at 1-800-4-CANCER or visit http://www.fda.gov/cdrh/dmqrp.html on FDA's Web site.
Rezulin (troglitazone), approved by FDA in January 1997, is used in combination with insulin or sulfonylurea in patients with adult-onset diabetes mellitus whose blood glucose levels are not adequately controlled by these other therapies alone. (See "Diabetes Demands a Triad of Treatments" in the May-June 1997 FDA Consumer.)
The 35 reports of liver injury, as of Oct. 21, 1997, ranged from mildly elevated blood levels of the liver transaminase enzymes to liver failure leading to one liver transplant and one death. It is not yet known if the drug alone caused the liver injury or if other medical factors contributed.
FDA and the drug's manufacturer, Parke-Davis, recommend checking patients' serum transaminase levels routinely for the first one to two months of Rezulin treatment, every three months for the rest of the first year, and periodically after that. Liver function tests should be done if a patient develops symptoms of liver dysfunction, such as nausea, vomiting, abdominal pain, fatigue, loss of appetite, or dark urine.
Patients should stop taking Rezulin if they develop jaundice or their laboratory tests indicate liver injury.
About 2 percent of patients are expected to have to stop taking Rezulin because of elevated liver enzymes. If the drug is stopped, few, if any, of these patients will develop permanent liver damage.
Health-care providers should report any Rezulin-related adverse events, especially those that suggest liver injury, to Parke-Davis by calling 1-800-223-0432, or to FDA's MedWatch program by calling 1-800-FDA-1088.
McNeil Consumer Products Co., of Fort Washington, Pa., announced recently it would:
The agency asked pharmacies last September to remove these two kits from their shelves: the "Lei-Home Access HIV Test," advertised on the Internet as the "Personal HIV Test Kit," and the "In-home Hepatitis A Test Kit."
The only HIV home test approved by FDA is the Home Access HIV-1 Test System, made by Home Access Health Corp., Hoffman Estates, Ill. Users send a blood sample obtained from a finger prick to a laboratory for testing. Confidential results are given over the phone, with a trained counselor available.
FDA has not approved a hepatitis A test kit for use in the home. Hepatitis A, usually transmitted by food, causes a mild, rarely serious, liver disease.
Consumers who used either of the unapproved kits should consult their doctors for retesting.
The new drug, Combivir, combines AZT (zidovudine) and 3TC (lamivudine), two drugs commonly prescribed with one another in "drug cocktails" as treatment.
Patients take one pill twice a day. Patients may need to take up to eight pills a day when taken separately.
AZT and 3TC are members of the nucleoside analog class of drug compounds, and both interfere with the replication of HIV, the virus that causes AIDS. Side effects of these drugs include: nausea, diarrhea, anemia, low white blood cells, pancreatitis, and neuropathy. Combivir was approved on Sept. 26, 1997, and is manufactured and marketed by Glaxo Wellcome of Research Triangle Park, N.C.
Beginning Sept. 30, 1998, labels of latex-containing medical devices will have to state, "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions." Similar labeling will be required on medical devices containing dry natural rubber and medical device packaging that contains latex.
Also, the rule will prohibit use of the claim "hypoallergenic" on labels of latex-containing medical devices. As now used on devices with reduced latex levels, the claim implies that such products are safe for latex-sensitive people. But even reduced amounts of latex can cause allergic reactions in susceptible people.
During the past decade, FDA received more than 1,700 reports of severe allergic reactions, including 16 deaths in children with spina bifida, related to medical devices containing latex. Health-care workers and children with spina bifida and other conditions requiring multiple surgeries are at greatest risk of allergic reaction because of their constant exposure to latex-containing devices. For the general public, the risk of allergic reaction is less than 1 percent.
FDA published the rule in the Sept. 30, 1997, Federal Register.
The agency's Center for Devices and Radiological Health approved 48 premarket approval applications in fiscal year 1997, five more than in 1996 and 18 more than in 1995. Key approvals included the first implant to restore partial hand movement in quadriplegics, a deep brain stimulator to help control tremors from Parkinson's disease, a nerve stimulator to reduce severe epileptic seizures, a temporary skin substitute for severe burns, and two fetal bladder stents to treat urinary tract obstruction in unborn babies. The center also cleared the first laser system for treating tooth decay.
Average review time for premarket approval applications was 16.6 months, down from 25.9 months in 1996, with 17 applications approved within 180 days or less. Average review time to clear 510(k) devices--those similar to existing products--was 97 days, down from 110 days in 1996, with 98 percent having an initial review decision within 90 days or less during the first three quarters of the fiscal year.
The center eliminated its approval application backlogs and continued, for the second year, a "zero" backlog of 510(k) clearances. Approval time for 70 percent of investigational device exemptions was 30 days or less, the quickest ever.
Consumers should make sure any laser surgery they undergo is done only with approved lasers or in an FDA-monitored clinical study. Unapproved lasers pose a risk of serious eye injury.
FDA has approved only two lasers as safe and effective for eye surgery. One is manufactured by Summit Technology Inc., of Waltham, Mass., the other by VISX Inc., of Santa Clara, Calif. Several others are in FDA-sanctioned clinical trials.
The lasers treat nearsightedness with photorefractive keratectomy (PRK), a procedure in which the surgeon reshapes the cornea with ultraviolet light bursts from the laser.
At press time, U.S. marshals, on behalf of FDA, had seized unapproved lasers from these sites:
Photon Data laser seized Aug. 28
Nicholas Caro, M.D.--one laser seized Sept. 2.
If made final, the rule would permit FDA to stop a company from conducting or continuing a study if women or men were being inappropriately excluded based only on the risk of damage to their reproductive organs or to the health of potential offspring. It would not apply to certain studies, such as those designed to look only at healthy volunteers or to test drugs for use exclusively by one gender, such as prostate cancer drugs.
FDA wants to expand access to new treatments for life-threatening diseases, believing that patients and their doctors can themselves weigh the risks and benefits of such treatments when given complete information during the informed consent process.
The agency hopes that diversity in drug studies will provide better information about how the drug will affect the people who will use it.
The proposed rule, published in the Sept. 24, 1997, Federal Register, provided a public comment period that ended Dec. 23.
FDA approved the Sacral Nerve Stimulation System last Sept. 29 to treat urge incontinence. This sudden, uncontrollable loss of urine is due to involuntary bladder wall contractions, which may result from such nerve conditions as spinal cord injury, stroke, and multiple sclerosis, or from other bladder problems. The device requires major surgery and is for use only when less invasive treatments, such as drugs and diet changes, fail. Of the 5 million adults, mainly women, who experience urge incontinence, 20 percent may benefit from the new treatment.
The battery-operated device consists of a pacemaker-size generator for implanting in the abdominal wall and a wire lead for attaching to the nerves near the sacrum, the large bone at the bottom of the spine. The generator sends electric impulses along the lead to the sacral nerves to help control bladder contractions.
After six months into clinical studies of 86 implanted patients, 47 percent of patients were dry, and an additional 28 percent had 50 percent fewer leakage episodes. Results were similar after 12 months and 18 months. In safety studies of 157 implanted patients, about a third had problems requiring at least a second surgery. Doctors could usually resolve the most common problem, pain, by repositioning the device.
The manufacturer, Medtronic Inc., of Spring Lake Park, Minn., must do a five-year study of the device to determine long-term effects.
Internet users can now directly access such documents as warning letters, inspection operation manuals, monthly import detention lists, medical device reports, and other often-requested materials without having to go through the time and paperwork of filing a traditional FOI request. Users can reach the Electronic Freedom of Information Reading Room directly from the FDA homepage.
FDA has also revised its homepage to include a greatly expanded index and special menus for such groups as consumers, health professionals, and industry.
The Innovations in American Government Awards Program, sponsored by the Ford Foundation and Harvard University's John F. Kennedy School of Government, recognized the agency for its efforts to speed the review of, and access to, new medicines. In addition to cutting approval times nearly in half, the agency has doubled the number of new drugs approved in a year.
The Nutrition Facts panel, now found on virtually all food labels, was tapped for the Presidential Design Achievement Award because of its useful, consumer-friendly design. The award recognizes exemplary achievements in federal design in such areas as architecture, interior design, urban planning, and graphic design.
FDA Consumer magazine (January-February 1998)