Baycol Pulled from the Market

Recently, the anti-cholesterol medication cerivastatin (Baycol) was voluntarily pulled from the market by the manufacturer because it has been linked with the deaths of 31 persons in the United States. The deaths were caused by rhabdomyolysis, an acute condition in which muscle is destroyed and released into the bloodstream. The condition causes severe pain and, in some patients, may lead to potentially fatal kidney or other organ failure.

While all of the popular cholesterol-lowering medications have been linked to very rare reports of rhabdomyolysis, cerivastatin has been linked to significantly more fatal cases than its competitors. The U.S. Food and Drug Administration (FDA) knows of 31 deaths since cerivastatin was approved for use in the United States in 1997. About 700,000 Americans have used cerivastatin.

According to the FDA, the rhabdomyolysis side effect of cerivastatin was reported most often in elderly patients, at higher dosages, and especially when the drug was used in combination with another cholesterol-lowering medication, gemfibrozil. In 12 of the 31 deaths in the United States, the patients were taking both medications.

The FDA warns that patients who are taking cerivastatin should call their physician about switching to a different cholesterol medication. Patients taking cerivastatin who experience muscle pain and are also taking gemfibrozil should immediately stop the medication and contact their physician. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, fever, dark-colored urine, nausea and vomiting. For more information, contact the FDA at 888-INFO-FDA (888-463-6332) or the manufacturer at 800-758-9794.

Cryosurgical Device to Treat Menorrhagia

The U.S. Food and Drug Administration (FDA) has granted marketing approval for Her Option Uterine Cryoblation Therapy System. The cryosurgical device is used for endometrial ablation in premenopausal women with menorrhagia from benign causes.

The therapy system involves a slender probe attached to a cooling unit. The probe is inserted through the cervix into the uterus. The tip of the probe is brought to a very low temperature to freeze and eliminate the uterine lining responsible for the excessive bleeding. Her Option is the first FDA-approved technique that uses hypothermia to destroy the endometrium, while other available uterine ablation technologies use extreme heat or electricity. Because the procedure can be controlled through the use of ultrasound guidance, a thorough level of ablation may be safely achieved.

In clinical trials of Her Option, no serious adverse effects were documented. For more information on Her Option, visit the CryoGen Web site athttp://www.cryogen-inc.com.

New Treatment for Alzheimer's Disease

The U.S. Food and Drug Administration has approved galantamine hydrobromide (Reminyl) for the treatment of mild to moderate Alzheimer's disease. According to the manufacturer, galantamine is derived from the bulbs of daffodils.

Galantamine is available in tablets of 4 mg, 8 mg and 12 mg. Patients should take the medication twice a day, preferably with meals. The approved recommended starting dosage is 8 mg per day in two divided doses, increasing to 16 mg after at least four weeks. The medication may be increased to 24 mg after an additional four weeks.

Data from four placebo-controlled, double-blind clinical trials show that galantamine can have a beneficial effect on patients' daily functioning and ability to think. Many patients' symptoms initially improved or stabilized, and even when symptom improvement began to decline, the patients who received galantamine remained better than those patients who were treated with placebo.

In clinical trials, adverse effects associated with galantamine were primarily gastrointestinal. Side effects that occurred in at least 5 percent of patients included nausea, vomiting, anorexia, diarrhea and weight loss.