People should stop use of either drug and discuss their treatment with their doctors.
The evidence comes from doctors who performed echocardiography to evaluate heart valve function in patients taking the drugs, FDA announced Sept. 15. About 30 percent of the patients had abnormal readings, even without symptoms. This percent is much higher than expected.
FDA did not request withdrawal of phentermine, the third widely used obesity drug. The combination of phentermine and fenfluramine, popularly known as "fen-phen," has been used off-label for obesity. (See "Mixing Diet Drugs Calls for Caution" in the Updates section of the September-October 1997 FDA Consumer.)
Colgate Total is the only toothpaste to contain the disinfectant triclosan as an active ingredient. It also contains fluoride.
Studies showed that, when used as directed in a conscientious program of oral hygiene and professional dental care, the new toothpaste performed significantly better than standard fluoride toothpaste in helping prevent plaque and gingivitis in adults. Its cavity-preventing effects were identical to toothpastes with fluoride alone.
FDA approved Colgate Total for ages 6 through adult, on July 14. However, its effects on plaque and gingivitis are not established in children.
Triclosan is found in many antibacterial soaps, but its antibacterial properties in the mouth have not been determined.
Colgate-Palmolive Co., of New York City, makes Colgate Total.
The measures include food-safety control programs for the industry, new labeling for products, and education programs for consumers and manufacturers. More than 98 percent of all fruit and vegetable juices are already pasteurized.
FDA advises people in the following high-risk groups to drink only pasteurized cider and juice:
If someone in your family is in a high-risk group and you cannot determine if a juice is pasteurized, the best choice is not to use it. Another choice is to bring the juice to a boil to kill any possible harmful bacteria.
Parents of children in day-care centers and schools that serve cider and juice may want to ask if the products are pasteurized. Children on field trips to apple cider mills or farm markets should not drink unpasteurized cider.
FDA plans to propose a new rule requiring Hazard Analysis and Critical Control Point (HACCP) safety programs at all appropriate juice processing plants. The agency is considering proposing another rule to require a statement of risk on labels of fresh apple juice products until the HACCP plans are implemented. Meanwhile, FDA has asked the industry to voluntarily begin immediately labeling fresh apple juice and cider with a statement of the risk.
Skin-Cap is imported from Spain and is marketed as a nonprescription spray, shampoo and cream for dandruff, seborrheic dermatitis, psoriasis, and other skin disorders. FDA issued an import alert in August for detention of Skin-Cap at all border entries, and the state of Florida stopped distribution of Skin-Cap from the product's primary distributor.
Consumers can call the National Psoriasis Foundation toll-free at 1-800-723-9166 for more information.
The Freehand System, approved Aug. 18, may help as many as 54,000 patients whose spinal cord injuries allow some use of the upper body. All 61 quadriplegics implanted with the medical device in clinical studies regained ability to grasp and release standard objects like forks and cans, although 20 percent needed further related surgery. Many patients reported improved daily activities and increased independence. Side effects included swelling, discomfort and skin irritation.
FDA learned that six asthma patients developed the syndrome while taking Accolate, the first nonsteroidal asthma drug, while their steroidal asthma drugs were being gradually lowered or discontinued. The new data do not show definitively that Accolate caused the syndrome, but the revised labeling urges careful monitoring while users are tapering off their steroid medications.
Churg-Strauss syndrome causes flu-like symptoms and may inflame blood vessels, especially in the lungs. Untreated, it can cause major organ damage or death.
In light of the syndrome's extremely rare occurrence, FDA believes Accolate's benefits outweigh its potential risks and recommends that patients not discontinue any asthma medication unless directed by a doctor.
(For more on asthma, see "Controlling Asthma" in the November 1996 FDA Consumer.)
The NeuroCybernetic Prosthesis System is approved for use with drugs or surgery in adults and adolescents with partial onset seizures. These seizures, which begin in one part of the brain, may remain localized or spread to the entire brain.
The July 16 approval came just 19 days after an FDA advisory panel recommended the device.
The new device has an electrical generator that is implanted under the collar bone with wires to the vagus nerve in the neck, where it delivers signals that stimulate the brain to control seizures. Doctors can change nerve stimulation settings with an external programming system, and patients can turn the device on and off by holding a magnet over it.
Approximately 1.7 million Americans have epilepsy. About 200,000 of these patients have seizures that cannot be adequately controlled by drugs or surgery. Severe, ongoing seizures can lead to death.
Clinical studies of the device included 454 patients. In the most recent study, half the patients had at least a 20 percent decrease in the number of daily seizures, one in four had a decrease of more than 50 percent, and one in five had increased seizures. Nine patients died, but clinical investigators did not believe stimulation from the device was the cause. FDA has asked the manufacturer, Cyberonics, of Houston, to provide detailed information on any further deaths.
The rule requires retailers to check photo ID's of buyers under age 27.
To order the full-color 17-by-22-inch poster in English and two smaller signs, one in English and one in Spanish, call FDA toll-free at 1-888-FDA-4KIDS. The materials also are available from the poster campaign's cosponsors.
For more information, call FDA's hot line or visit the agency's World Wide Web site at http://www.fda.gov/opacom/campaigns/tobacco.html. (See also "Saving Our Children from Tobacco" in the October 1996 FDA Consumer.)
Most drugs and biologics today are not labeled for use in children, despite a 1994 regulation making it easier for drug manufacturers to submit pediatric data voluntarily.
"When drug labels do not include adequate pediatric information, health-care providers are forced to play a guessing game that may compromise the care of their patients," says Michael A. Friedman, M.D., FDA lead deputy commissioner.
According to the proposal, manufacturers could submit pediatric data after approval if FDA has safety concerns about previous testing in children. Pediatric data would not be required if the product was likely to be unsafe or ineffective in children, if pediatric studies were impossible or highly impractical, or if reasonable efforts to develop a pediatric formulation had failed.
The public has until Nov. 13 to send written comments on the rule to: FDA Dockets Management Branch, HFA-305, Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. FDA published the proposal in the Aug. 15, 1997, Federal Register, available in some libraries and on the agency's Web site at http://www.fda.gov/cder/guidance/pedrule.htm.
FDA approved the Activa Tremor Control System July 31 to control the arm and hand shaking caused by essential tremor, a little-understood nerve disorder, and Parkinson's disease.
The manufacturer, Medtronic Inc., of Minneapolis, tested the device in 196 patients with severe tremors caused by the two conditions in the United States and Europe. In the U.S. study, on a scale of 0 to 4, tremors declined two or more levels in 67 percent of Parkinson's patients and 58 percent of patients with essential tremor. Tremors declined one level in most of the other patients. The European findings were similar.
The reduction in tremors improved daily activities for patients with essential tremor. But most Parkinson's patients continued to have problems with activities of daily living, and a few had worsening of the tremor.
FDA requires additional studies by Medtronic to determine the device's long-term safety and effectiveness and the effects of replacing broken leads and implanting multiple leads.
Using cartilage cells known as autologous cultured chondrocytes, the new product, Carticel, was approved Aug. 25 to treat injuries to the end of the thigh bone behind the kneecap, but not for patients with damage to the kneecap or lower leg bones or with arthritis.
The product is used along with other procedures, including the removal of damaged tissue and the surgical addition of tissue taken from the patient's bones to cover the defect. Thorough, extensive rehabilitation is considered critical to recovery.
Carticel is the first product approval under FDA's new document for industry, called the manipulated autologous structure guidance. The document deals with products made of living human cells that are manipulated outside the body and then returned to the patient for structural repair.
Case reports of 153 patients treated in Sweden with Carticel showed improvement in 70 percent of those followed 18 months after treatment. Biopsies on 22 treated patients showed 15 had developed hyaline cartilage, which the body uses to absorb shock and friction and which usually does not form after injury. Early data from a registry of U.S. patients treated with Carticel were consistent with the Swedish study.
FDA grants accelerated approval to products that treat serious or life-threatening illnesses when studies of the products indicate early favorable outcomes will likely predict clinical benefit. However, companies must do further studies to verify the benefits.
The sponsor of Carticel, Genzyme Tissue Repair, in Cambridge, Mass., will conduct two such randomized control studies.
FDA Consumer magazine (November-December 1997)