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Updates

New Drug for Bone Disorders

Within six months of the manufacturer's submission of the application, FDA approved a new drug to treat two bone disorders: osteoporosis in postmenopausal women and Paget's disease.

Fosamax (alendronate) is the first bisphosphonate drug approved for osteoporosis, providing an alternative to estrogen and calcitonin, previously approved treatments. Fosamax was approved last Sept. 29. Other bisphosphonates were previously approved for Paget's disease.

Osteoporosis is a condition of low bone mass and reduced bone strength that leads to fractures of the spine, wrist and hip. In Paget's disease, normal bone is replaced with poor quality bone.

In two three-year studies of more than 900 patients, bone strength increased 8.16 percent in patients receiving alendronate and decreased 0.65 percent in those receiving a placebo. In addition to the drug therapy, patients received a daily dietary calcium supplement. Adverse effects associated with the drug include nausea, heartburn, flatulence, and abdominal pain.

Fosamax should be used in conjunction with an adequate diet, including enough vitamin D and calcium, and an exercise program. The drug should be taken in the morning at least a half hour--preferably a full hour--before eating or taking other medication.

The manufacturer is Merck and Co., of West Point, Pa.

New Device to Treat Aneurysms

The first detachable coil for insertion through blood vessels of the brain to treat inoperable or high-risk intracranial aneurysms was recently cleared for marketing by FDA. The Guglielmi Detachable Coil (GDC) is the first device of its type capable of being controlled during placement in the aneurysm.

An intracranial aneurysm is a weak, balloon-like defect protruding from an arterial wall on or inside the brain. The aneurysm can rupture, causing hemorrhagic stroke, an event that results in death in more than half the cases. Each year, about 10,000 patients are diagnosed with inoperable or high-risk intracranial aneurysms.

Aneurysm rupture causes sudden severe headache, which may be combined with nausea and vomiting. The patient may become unconscious. Intact aneurysm may occur without symptoms, or may cause headache, dizziness, visual problems, nausea, vomiting, and numbness.

The GDC is a soft platinum alloy micro-coil. Treatment usually requires insertion of five to six coils.

In a controlled manner, the surgeon uses a micro-catheter to thread each coil through blood vessels to the aneurysm site. Application of a very-low-voltage electric current detaches and releases the coil into the aneurysm. Once in place, the GDC coils fill the aneurysm, isolating it from circulation to reduce the likelihood of rupture and hemorrhagic stroke.

In clinical trials, only 3.7 percent of hemorrhagic stroke patients treated with the GDC had a second such stroke during the following 7.3 months. Medical literature reports a 30 to 40 percent re-rupture rate in patients with other treatment.

Among non-stroke patients treated with the GDC for very large aneurysms causing symptoms, the death rate from all causes after 11 months was 12.8 percent. Medical literature reports a 62 percent death rate over two years for such patients receiving other treatment.

Thirty percent of patients treated with the GDC had adverse events, many of which were mild or moderate. More serious events included aneurysm re-rupture, blood clot particles blocking blood vessels (thromboembolism), and perforation of the aneurysm during placement of the coils.

The GDC is manufactured by Target Therapeutics, Inc., of Fremont, Calif. It was cleared for marketing last Sept. 8.

(For information about different types of aneurysms, see "Aneurysms Difficult to Diagnose, Complex to Cure" in the October 1992 FDA Consumer.)

Medicare Extends Coverage To Some Investigational Devices

Under a new policy that became effective last Nov. 1, the Health Care Financing Administration is extending Medicare coverage to pay for "new generations" of medical devices while they are still under study for marketing approval. Typically, these are new versions of proven technologies already covered by Medicare. Reimbursement will be the same as for comparable approved devices.

Federal law prohibits Medicare from paying for "experimental" devices still in clinical trials because safety and effectiveness have not been established. Under HCFA's new policy, FDA will help the agency identify "nonexperimental" devices eligible for the extended coverage.

"All new devices need to undergo clinical trials, but most actually represent refinements and improvements to existing devices," says FDA Commissioner David A. Kessler, M.D. "This is an opportunity for teamwork between HCFA and FDA to stimulate product development and make new generations of technology available more quickly."

Medicare coverage for new generation devices will likely foster patient enrollment in clinical trials and thus may encourage innovation.

Treatment IND for Kidney Cancer Treatment

People suffering from advanced kidney cancer will have expanded access to the first somatic cell therapy available under FDA's Treatment IND (investigational new drug) regulations.

Somatic cell therapies use living cells, processed outside the source, for the prevention, diagnosis or treatment of diseases or injuries. In autolymphocyte therapy (ALT), the technology being investigated for metastatic (stage IV) renal cell (kidney) cancer, white blood cells are extracted from the patient, stimulated, and reintroduced into the patient to help augment the immune system.

Treatment INDs allow patients suffering from serious or life-threatening conditions who have exhausted established treatments or for whom no satisfactory treatment exists to obtain promising experimental drugs that have undergone sufficient clinical testing to show they may be safe and effective.

FDA granted expanded access to ALT last September based on clinical data that the activated somatic cells may decrease tumor size with few serious side effects in a small percentage of patients.

The only approved treatment for metastatic kidney cancer is Proleukin (interleukin-2). However, some patients cannot tolerate Proleukin's side effects or do not respond favorably to the drug.

Under special permission from FDA, ALT's manufacturer, Cellcor Inc., Newton, Mass., is permitted to recoup costs for the treatment. Usually, manufacturers cannot charge for a drug before it is approved. Patients and health-care professionals can obtain more information about the treatment and enrollment criteria by calling Cellcor at (1-800) 441-7901.

Thalidomide Use in AIDS Treatment

Thalidomide would become more readily available to patients with AIDS wasting syndrome under a revised research protocol being considered by FDA, AIDS buyers' clubs, and a pharmaceutical company at press time in November.

FDA had warned the buyers' clubs last September to stop selling the drug to people not enrolled in approved studies. Most buyers' clubs then said they planned to stop the practice in anticipation of the wider protocol study. Some referred callers to FDA. Because of the health risks, FDA believes the investigational drug should be used only in carefully monitored clinical trials.

Thalidomide may cause adverse effects on the patient's nervous and immune systems and is known to cause severe birth defects. Never approved in the United States, the drug was sold in other parts of the world in the 1950s and 1960s and became notorious for causing severe fetal malformations when taken by pregnant women for nausea. The drug was linked worldwide to the birth of an estimated 7,000 to 12,000 babies without properly developed arms and legs.

FDA has authorized an expanded access protocol for thalidomide clinical trials of HIV wasting syndrome so that substantially more people with the syndrome may enroll in the studies. Information on the AIDS' studies can be obtained by calling the AIDS Clinical Trials Information Service at (1-800) TRIALS-A.

FDA believes thalidomide should be used only under medical supervision and with informed consent, both of which are not usually available outside of carefully monitored clinical trials. In addition, the illegal distribution of thalidomide by buyers' clubs may hinder enrollment in clinical trials, thereby delaying the determination of whether the drug is safe or effective for treating certain conditions.

In clinical studies, thalidomide has been investigated for treating erythema nodosum leprosum, a serious inflammatory condition in patients with leprosy. The drug also is being investigated for aphthous ulcers, painful HIV-related sores in the mouth and throat, and for AIDS-related wasting syndrome.

FDA allows AIDS patients with aphthous ulcers who are not eligible for larger thalidomide clinical trials treatment to get thalidomide through their doctors by means of single-patient INDs (investigational new drug applications). This allowance is based on early data showing the drug may effectively treat the ulcers.

There already are two drugs approved for AIDS-related wasting: Marinol (dronabinol) and Megace (megestrol acetate). (See "Warding Off HIV Wasting Syndrome" in the April 1995 FDA Consumer.) In addition, FDA has granted a Treatment IND for Serostim (somatotropin) to treat AIDS wasting.

The buyers' clubs receiving the FDA warnings in September were LifeLink of Arroyo Grande, Calif., Healing Alternatives of San Francisco, and PWA Health Group of New York City.

Fish on the Web

New information on seafood has been added to the agency's World Wide Web site by FDA's Center for Food Safety and Applied Nutrition.

Featured are links to the FDA Seafood List and the Regulatory Fish Encyclopedia, which was developed to help federal, state and local officials and purchasers of seafood identify species substitution and economic deception in the marketplace.

For 27 of the more frequently consumed fish, the encyclopedia includes:

Selected chapters from the center's handbook "Foodborne Pathogenic Microorganisms and Natural Toxins" (also known as "The Bad Bug Book") are online, with hypertext links to relevant documents from the national Centers for Disease Control and Prevention and U.S. Department of Agriculture.

Also included is information on the FDA Seafood Hotline, the agency's pesticide monitoring program, and links to the FDA Import System, which includes access to FDA import alerts.

To locate the new information, go to http://vm.cfsan.fda.gov/list.html and select "Seafood" (which is flagged with a red "new" icon).

Plan to Reduce Vibrio Infections

The Interstate Shellfish Sanitation Conference (ISSC)--made up of representatives from FDA and other federal and state regulatory agencies, industry, and academia--has developed a plan to reduce risk of infection from Vibrio vulnificus, a potentially harmful bacterium found in raw or partially cooked oysters.

The plan is an interim measure while officials explore other ways to curb the bacterial infection.

Vibrio vulnificus can be life-threatening to people with serious underlying health problems such as liver disease, diabetes, cancer, or immune disorders. Such people should not eat any raw or partially cooked animal protein products, including oysters. Because some of these health problems have no symptoms, individuals may not know they are at risk. Those uncertain should check with their doctors.

The ISSC plan calls for states whose waters have been confirmed as the original source of oysters associated with two or more Vibrio vulnificus illnesses to require that oysters be refrigerated within a specified time after harvest to slow the bacterium's growth. The higher the water temperature, the sooner the oysters would have to be refrigerated.

For example, oysters taken from an affected site during a month with an average monthly maximum water temperature of more than 84 degrees Fahrenheit (29 degrees Celsius) would have to be chilled within six hours of harvesting. Oysters from cooler waters could be kept unchilled correspondingly longer. The times between harvest and cooling result from FDA research on how rapidly Vibrio vulnificus multiplies in unrefrigerated oysters after harvest.

For more information on oysters and related subjects, call the FDA Seafood Hotline, (1-800) FDA-4010. Information is also available on the agency's World Wide Web site (see "Fish on the Web" in this section).

FDA Issues Warning About Hospital Bed Side Rails

Hospital bed side rails pose a risk of trapping certain patients during use, FDA warned in a recent safety alert to health-care workers.

Since January 1990, FDA has received 102 reports of head and body entrapments involving hospital bed side rails. The 68 deaths, 22 injuries, and 12 entrapments without injury occurred in hospitals, long-term care facilities, and private homes. Although the number of reported incidents is small compared to the large number of patients who use hospital beds--well over a million, according to some estimates--appropriate precautions can further reduce accidents, the Aug. 23, 1995, alert stated.

All reported entrapments occurred in one of the following ways:

All deaths involved entrapment of the head, neck or chest, while most injuries involved fractures, cuts and abrasions to the arms and legs. The majority of deaths and injuries involved elderly patients. Patients at high risk include those who are mentally unstable, restless, lack muscle control, or a combination of these factors. Risk also increases if the bed dimensions are inappropriate for the patient's size and body weight.

FDA recommends the following to people caring for patients in hospital beds:

Injuries from hospital bed side rails should be reported to FDA's Medical Product Reporting Program, MedWatch (HF-2), Rockville, MD 20857; telephone (1-800) FDA-1088; or computer modem (1-800) FDA-7737.

Free Lupus Education Kit

A free education kit on lupus can help local organizers alert young black women to signs of this serious immune disorder.

Affecting as many as 1 in 250 black women, lupus has an incidence, prevalence and death rate three times higher in black women than in white women. (See also "Living with Lupus" in the December 1989-January 1990 FDA Consumer.)

"What Black Women Should Know About Lupus: Ideas for Community Programs" is available from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. To order a free copy, write: Lupus Kit, NAMSIC, National Institutes of Health, 1 AMS Circle, Bethesda, MD 20892-3675; telephone (301) 495-4484; TDD (301) 565-2966.

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FDA Consumer magazine (December 1995)