Finally we are seeing some recognition of this potential interaction in the press releases. And it is being used as a marketing point.
FDA Clears New Labeling for Pravachol(R) Pravastatin Sodium)
Labeling Addresses Reduced Potential for Cytochrome P450 3A4 Drug Interactions
PRINCETON, N.J., June 9 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has cleared enhanced labeling for Pravachol(R) (pravastatin sodium), an HMG-CoA reductase inhibitor, which addresses the drug's reduced potential for interactions with certain medicines. Pravachol, marketed by Bristol-Myers Squibb (NYSE: BMY, is metabolized differently than other drugs in its class. As a result of its different biochemical properties, Pravachol is not metabolized by the cytochrome P450 3A4 system to a clinically significant extent. Therefore, it has reduced potential to interact with some commonly-prescribed medications such as diltiazem, which is used to control blood pressure and itraconazole, which is prescribed to treat infections.
The cytochrome P450 3A4 system contains enzymes that metabolize drugs so that they can eventually be eliminated from the body. Many of the other drugs in the HMG class are metabolized by the cytochrome P450 3A4 system. As recently as last year, the FDA addressed the issue of the differences between HMGs, otherwise known as "statins," and the potential for drug interactions in an FDA Talk Paper dated December 19, 1997.
There are a number of frequently prescribed medications which state in their labeling that they are either metabolized by or inhibit the cytochrome P450 3A4 system. These medications include erythromycin, Prozac (fluoxetine), and Viagra (sildenafil). Even certain foods such as grapefruit juice can cause interactions when taken in combination with medicines that are metabolized by the cytochrome P450 3A4 system.
"The issue of interactions between medications, whether taken in combination with other drugs or certain foods, has become increasingly important," said Daniel J. Rader, MD, director, Preventive Cardiology, University of Pennsylvania Medical Center, Philadelphia. "This new labeling provides both physicians and patients with significant information about Pravachol."
In general, the effects of drug interactions can range from mild to severe and may include weakness, fatigue, muscle aches, and rash. These effects can often be confused with common medical problems, such as arthritis pain, or the side effects from taking an individual medication. It is very important for patients to contact their healthcare provider as soon as possible if they experience any of these symptoms.
Pravachol is the most widely studied medication of its kind and is the only drug in its class proven to reduce the risk of a heart attack in patients with and without established coronary heart disease. To date, Pravachol has been studied in more than 30,000 patients in placebo-controlled clinical trials, including the West of Scotland Coronary Prevention Study (WOSCOPS), the Cholesterol and Recurrent Events (CARE) Study, and most recently, the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) study. Importantly, the FDA recently cleared a significant new indication for Pravachol for reducing the risk of stroke or transient ischemic attacks, otherwise known as "miniature" strokes, in patients who have had a heart attack and have normal cholesterol levels (total cholesterol less than 240 mg/dl; LDL cholesterol 101-180 mg/dl), and to reduce the risk of recurrent heart attack and undergoing myocardial revascularization procedures in this patient population.
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 nursing, or people who are allergic to any component of the medication. Muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor.
The risk of myopathy with another HMG-CoA reductase inhibitor is increased with concurrent therapy with erythromycin, cyclosporine, niacin, and fibrates. The combined use of pravastatin and fibrates should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.
Bristol-Myers Squibb licensed Pravachol 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 for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological 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. |
