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Updates

Second Alzheimer's Drug OK'd

Aricept (donepezil) is a "cholinesterase inhibitor" that increases levels of a neurotransmitter important to memory, judgment, ability to reason, and other cognitive functions. The drug was approved last Nov. 25. Tacrine (cognex) was approved in 1993 to treat the disease.

Alzheimer's disease affects an estimated 4 million Americans.

In a 30-week trial of 473 patients, those treated with Aricept improved on two assessment scales compared with those on a placebo. A second 15-week study confirmed these results. One scale gauged memory, attention, language, and reasoning. The other was a physician's interview-based evaluation to confirm treatment benefit.

In the trials, most patients tolerated typical side effects of diarrhea and nausea. Other possible side effects include a slowed heartbeat and fainting spells.

Eisai America Inc., Teaneck, N.J., and Pfizer, New York City, market Aricept.

(For more on the disease, see "Despite New Clues, Alzheimer's Mystery Remains Unsolved" in the March 1992 FDA Consumer.)

FDA Proposal Aims to Protect
Animals, Humans from Diseases

These animal diseases are known as transmissible spongiform encephalopathies (TSEs), which are characterized by a long incubation period and a relatively short clinical course of neurological signs, leading to death. A major concern is that one type of animal TSE, bovine spongiform encephalopathy (BSE), could in the future be identified as the cause of a new TSE in humans.

In March 1996, the British government announced a possible link between BSE and 10 cases of a variant form of Creutzfeldt-Jakob disease, a degenerative nerve disorder in humans. That same month, U.S. national livestock organizations and professional health groups announced a voluntary moratorium on the use of ruminant protein in ruminant feed.

Although there has never been a reported case of BSE in the United States, FDA proposed the new rule as a precautionary measure. "It will add another level of safeguards to protect the U.S. against the potential risk from these diseases," said Donna E. Shalala, Secretary of Health and Human Services.

FDA's proposal would ban nearly all potential sources of ruminant and mink protein in feed for ruminants. Bovine blood and ruminant-derived milk and gelatin would be excepted, however, as FDA has no information suggesting these proteins are potential carriers of TSEs.

FDA published the proposal in the Jan. 3, 1997, Federal Register. The agency also published the fact sheet "Bovine Spongiform Encephalopathy and Creutzfeldt-Jakob Disease, Public Health Service Actions to Ensure Against Health Risks" [Note: For information on these publications, visit FDA's Center for Veterinary Medicine on this Website.] Single copies can be ordered by writing to FDA, HFI-40 , Rockville, MD 20857.

Leukemia Drug Approved for Prostate Cancer

Studies showed that Novantrone (mitoxantrone), in combination with steroids, can reduce the intense pain that occurs as cancer cells multiply and spread to the bone. The drug combination also was shown to stabilize or reduce reliance on analgesic pain relievers.

FDA's Nov. 13 approval of Novantrone's new use came less than six months after the manufacturer applied for the new use. The application was one of the first following FDA's announcement of a new plan to speed cancer drug approvals.

Prostate cancer is the second leading cause of cancer deaths in the United States. Of the 310,000 new cases that were expected to be diagnosed last year, more than 40,000 of them will likely become resistant to hormone therapy.

In clinical trials, the Novantrone-steroids combination significantly reduced pain in 38 percent of patients, compared with 21 percent of those treated with steroids alone. Patients responding to Novantrone had an average eight months of pain relief, compared with two months for those given steroids alone. However, survival rates for both groups were the same.

Immunex Corp., Seattle, markets Novantrone.

(For more on prostate cancer, see "Prostate Cancer: New Tests Create Treatment Dilemmas.")

Toll-Free Number Gives
Cosmetics, Colors Information

The line gives information on cosmetics- and colors-related recalls and other current public health issues. It also provides general information on such topics as cosmetic labeling and ingredients, hair dyes, aromatherapy, and sun care, and tells how to report adverse reactions. For additional information, callers can request that related documents be faxed or mailed to them.

The telephone number is (1-800) 270-8869. Callers must use a touch-tone telephone to access the information line, which can be reached 24 hours a day.

Ivermectin Approved
For Two Parasitic Diseases

Strongyloidiasis is common in many tropical countries and is occasionally acquired in some areas of the United States. Infection is usually confined to the small intestine. It can persist for many years, causing abdominal pain, diarrhea, and elevated levels of white blood cells. In people with weakened immune systems, the infection can spread through the body and be fatal.

Onchocerciasis, commonly known as river blindness, is most often found in Africa and South and Central America. The parasite is transmitted by the bite of a black fly, which deposits immature forms of the parasite under the skin. There, the worms mature and the adult females produce more larvae. The immature worms migrate under the skin, causing intense itching. They can also migrate to the eyes, causing inflammation and blindness.

Ivermectin is better tolerated than other drugs approved to treat these conditions, and it is more effective than the previously approved treatment for onchocerciasis. In clinical studies, a single dose of ivermectin cured between 64 and 100 percent of patients with strongyloidiasis who had normal immune systems. In studies of onchocerciasis, a single dose of the drug reduced the number of larvae under the skin an average of 83 percent at three days and 99.5 percent at three months. Adverse reactions to the drug differ depending on which disease is being treated but can include skin rashes, itching, dizziness, diarrhea, and nausea.

Merck & Co. Inc., of West Point, Pa., sells ivermectin in the United States under the trade name Stromectol. (Elsewhere it is marketed as Mectizan.) Before its approval on Nov. 25, 1996, ivermectin had been available here for limited human use as an investigational drug.

Ivermectin has been used worldwide since 1987 to treat river blindness. More than 5.2 million people have received the drug through the World Health Organization's Onchocerciasis Control Program and Merck's Mectizan Donation Program.

(See also "Treating Tropical Diseases" in the January-February 1997 FDA Consumer.)

First Rx Drug for Severe Mouth Sores

The agency approved the drug, Aphthasol (amlexanox oral paste, 5 percent), Dec. 17. In clinical studies, Aphthasol reduced ulcer healing time by a day to a day and a half, compared with a placebo or no treatment. Pain was relieved as the ulcers healed. Some participants reported stinging or burning where the medicine was applied, and, less frequently, nausea and diarrhea.

While people with AIDS acquire especially virulent aphthous ulcers, the new drug's safety and effectiveness in individuals with weakened immunity has not been assessed at this time.

Users should apply Aphthasol paste directly to their ulcers four times a day, following oral hygiene after meals and before bedtime. If the ulcers have not healed in 10 days, patients should visit their dentists or health-care providers.

Aphthasol is manufactured by Block Drug Co. Inc., Jersey City, N.J.

FDA Offers Quick Info
On Blood Product Recalls

The agency's Center for Biologics Evaluation and Research has established a 24-hour toll-free number--(1-888) CBER-BPI--and an automated electronic mailing list. Both provide current information on recalls and market withdrawals of therapeutic products derived from blood, such as immune globulins and clotting factors to treat hemophilia. In a recall, a product is taken off the market because it violates a federal law. In a market withdrawal, a product is removed from the market by the manufacturer for some other reason.

These new systems augment CBER's existing methods of notification, which include the FAX Information System (1-888-CBER-FAX), a consumer information line (1-800-835-4709), and a link from FDA's home page on the World Wide Web.

Public Can Comment
On Device Proposal

Written comments on the proposal, published in the Dec. 19, 1996, Federal Register, may be sent to the FDA Dockets Management Branch, HFA-305, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. The Federal Register document is available at some libraries and on FDA's World Wide Web site at http://www.fda.gov/cdrh/fr1219af.html.

Under the proposal, experimental devices could be granted "treatment use" status, meaning they could be used to treat or diagnose only patients whose illness poses a significant threat of death within months or premature death if the course of disease is not altered quickly. The proposal would ensure that data gathered from the treatment could be used to evaluate product safety and effectiveness. It also would ensure integrity of the clinical studies and prevent commercialization of the device during this phase.

Normally, a sponsor must obtain an Investigational Device Exemption, or IDE, from FDA to use an experimental device on human patients. Only patients enrolled in the studies can be treated with the device. Then, in the marketing application, the sponsor uses the study data to show product safety and effectiveness.

Under FDA's proposal, patients would not have to be enrolled in a study. But a sponsor desiring "treatment use" for an experimental device would have to submit a Treatment Use IDE application to FDA, showing that:

• The device is intended to treat or diagnose a serious or immediately life-threatening disease or condition.

• No comparable or satisfactory alternative device or other therapy is commercially available.

• The device is under investigation in an approved IDE or that such studies have been completed.

• The manufacturer is pursuing marketing approval.

Brochures Available

• Losing Weight Safely (FDA) 96-1247
• Protect Your Child from Poisons in Your Home (FDA) 96-1262

To order single copies, write to FDA, Rockville, MD 20857. To order 2 to 100 copies, write to FDA, HFI-40, at the same address, or fax your order to (301) 827-5308. Include the publication number.

Correction