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| |  FDA Clears New Labeling for Pravachol; Less Frequent Liver Testing Needed PRINCETON, N.J., April 24, 1997 -- The U.S. Food and Drug Administration (FDA) has cleared new labeling for the cholesterol-lowering drug Pravachol(R) (pravastatin sodium), eliminating the recommendation for liver function testing at six weeks and for semiannual testing in patients with normal test results at 12 weeks. For patients taking Pravachol, a HMG CoA reductase inhibitor (HMG), it is recommended that liver function testing be performed prior to, and at 12 weeks following initiation of therapy or the elevation of dose. (Testing after 12 weeks would need to be performed if there is an abnormal test result or signs and symptoms of liver disease.) Currently, for all other HMG drugs, liver function testing is recommended prior to, and then at six and 12 weeks after the initiation of therapy or an elevation in dose, and periodically thereafter, e.g., semiannually. Pravachol is the only HMG to receive clearance from the FDA for less frequent liver function testing. The new labeling is based on safety data from the Pravastatin Primary Prevention Study (also known as the West of Scotland Coronary Prevention Study), a landmark five-year clinical trial which demonstrated the effectiveness of Pravachol in reducing the risk of a first heart attack and death from heart disease in 6,595 men with elevated cholesterol and no history or symptoms of heart disease. According to the results of the study, Pravachol reduced the risk of a first heart attack by 31 percent; reduced the risk of death from cardiovascular disease by 32 percent; and reduced the need for surgery to clear blocked arteries, such as bypass surgery and angioplasty, by 37 percent. Pravachol is also the only HMG proven to reduce the risk of heart attack in both patients with and without established coronary heart disease. To date, Pravachol has been studied in placebo controlled clinical trials in nearly 30,000 patients. "Routine liver function testing can be problematic for physicians and a worry for patients. The FDA clearance of the new Pravachol labeling will mean less frequent liver function testing, which translates to cost and time savings for insurers, physicians and patients," said Daniel J. Rader, MD, Director, Preventive Cardiology, University of Pennsylvania Health System. "It also confirms the overall safety of Pravachol and further emphasizes that people with high cholesterol who are at risk for heart disease should not avoid treatment because of concerns about liver safety." More Americans die from heart disease than from any other cause. The statistics alone provide compelling evidence of the devastation of the disease. This year, approximately 1.5 million Americans will suffer a heart attack. Of these people, 500,000 will die as a result of heart attack. About two-thirds of heart attacks are first heart attacks and nearly one-third of these are fatal. Approximately 17 million Americans with high cholesterol but no history or symptoms of heart disease are considered at risk for a first heart attack. In addition, approximately four million Americans have high cholesterol and established heart disease and are at risk for coronary heart disease events, such as heart attack. Pravachol therapy is well tolerated by most patients. The most common side effects include mild skin irritation and transient rash and gastrointestinal upset. Pravachol should not be used by people with active liver disease or liver problems, in women who are pregnant or breast feeding, or people who are allergic to any component of the medication. Bristol-Myers Squibb licensed pravastatin from its discoverer, Sankyo Company, Inc., of Japan. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies from cardiovascular, metabolic and infectious diseases, central nervous system and dermatologic disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products.
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