New FDA warnings about popular medicines
One of the important issues facing the United States today is health care. Legislative and institutional reform is rapidly changing the way medicine is practiced in this country. Original clinical studies are now being shown to have serious flaws. This new research highlights the safety risks for citizens and the need for the Federal Drug Administrative (FDA) to issue new warnings/advisories about these drugs.
Some of the FDA warnings and revisions reported in 2011 were in regard to Plavix, Coumadin and Simvastatin. The FDA approved these three drugs for specific uses. However, because of numerous experts in the medical field raised doubts on beneficial use for these prescription drugs, the FDA has been reviewing the original research and approvals.
Plavix is used for plaque control in blood vessels and Coumadin is a blood thinner for clot control associated with stroke and coronary heart disease. Simvastatin (Zocar) is a statin used to control blood cholesterol, fats and triglycerides.
These new FDA analysis indicate that Plavix may be no more effective than aspirin, but has the potential to cause serious health risk for heart attack, stroke and internal bleeding. It is now recommended Plavix should not be used as a preventive drug for stroke or heart attack. But this drug may have beneficial effects following a stroke or coronary heart attack.
Coumadin is an anticoagulant used as a blood thinner to prevent clots from forming in the body's circulatory system. However, adverse reactions to this drug are rapidly because a leading cause of death in the U.S. While blood clots are cause for heart attack or stroke, Coumadin may also prevent harmful clots from forming to help reduce risk of future strokes or heart attack.
Many cardiologists today prescribe both Plavix and Coumadin following the implantation of an arterial stent. Ironically, Plavix inhibits the activity that eliminates Coumadin from the body. Some researchers believe this could increase blood levels of the anticoagulant, thus also increasing risk of bleeding due to over thinning of the blood.
Simvastatin (Zocor) is a statin-class drug used to control cholesterol, fats, and triglycerides. This drug is known to have a higher risk rate than other approved statins. Many recommend that the drug should no long be prescribed at the maximum allowed dosage amount due to an increased risk for muscle damage to occur. Muscle pain and weakness are a common side effect of all statin drugs. Researchers have proposed that as the muscle tissue breaks down, harmful proteins are released into the blood stream. This increase in blood protein levels may be the cause for kidney damage that may have life-threatening complications.
The FDA should be vigilant and constantly re-examine the effects of prescription drugs on the large patient population and, if necessary, mandate changes in dosage and appropriate usage of these and all prescription drugs.
Jim Thorpe, Pa.