The Dangers of Defective Prescription Drugs
The U.S. Food and Drug Administration diligently regulates and monitors the dangers of prescription and non-prescription drugs in America. And every year the FDA forces drug manufacturers to recall hundreds of medications from pharmacy shelves. Since 2000, the FDA has issued recalls for an average of 300 prescription and over-the-counter drugs because of safety concerns – each year. A hand full of these are responsible for thousands of deaths or injuries.
As outlined by the FDA, there are several types of medicinal defects that the regulatory agency screens for such as unavoidable and avoidable known side effects, medication errors, product quality defects, and preventable adverse events including injury and death. The FDA admits that the number of new drugs and the complexity of clinical trials compels the organization to approve some drugs before they can thoroughly review them.
The FDA explains that the pre-approval of certain drugs allows more Americans to enjoy the benefits of cutting edge medicines. But this also means that many defective drugs will be widely available to the public before sufficient safety information is compiled putting many people at risk of serious side effects.
The Vioxx® Worldwide Recall
The prescription pain killer Vioxx® was the target of the largest recall in history when it was publicly disclosed on September 30, 2004, that the drug was linked to an alarming increase of heart failure risk in regular users. A member of the now infamous family of COX-2 inhibitors, Vioxx® is a non-steroidal, anti-inflammatory pain medication used to quell symptoms of menstrual, arthritis, and other chronic muscle and joint pain. Originally approved by the FDA in May of 1999, Vioxx® was touted as a wonder drug for pain management even though it was then known to cause heartburn, stomach ulcers or bleeding, nausea, diarrhea, high blood pressure, fatigue, vomiting, dark urine, and black stools. Vioxx® is now alleged to be the cause of untold deaths throughout the world. Manufactured by Merck & Co., Inc., Vioxx® was prescribed to an estimated 84 million users worldwide.
Questions About Celebrex®
Celebrex®, a prescription pain medicine similar to Vioxx® has recently come under fire with serious questions of safety. Investors of Pfizer, Inc., the makers of Celebrex®, filed a class action lawsuit against the manufacturer after a government-led clinical trial that ended in December 2004 showed an increased risk of heart failure in patients taking regular doses twice daily over an extended period of time. Pfizer has not been forced to recall Celebrex® from pharmacies because results from other documented clinical studies show the drug to be relatively safe and effective. Regardless of the discrepancy in findings, Celebrex® sales have dramatically decreased as patients and doctors alike grow increasingly wary of the side effects of drugs in the COX-2 inhibitor class. Other known side effects of Celebrex® include stomach ulcers, gastrointestinal bleeding, abdominal pain, dyspepsia, and diarrhea.
Prempro® Risks Prompt Recall
In July of 2002, scientists of the National Heart, Lung and Blood Institute in Maryland abruptly halted the Women’s Health Initiative (WHI) study of postmenopausal hormone replacement therapy upon findings of serious associated health risks. Results of the exhaustive study showed that hormonal therapy using drugs such as Prempro®, which combine estrogen with progestin, significantly increased a patient’s risk of breast cancer and heart failure. Findings of this landmark trial warned that women taking Prempro® could expect a 26% increased risk of breast cancer, a 29% increased risk of cardiovascular disease, and a frightening 41% increased chance of stroke. Similar warnings from the American Heart Association and the American Medical Association prompted Wyeth Pharmaceuticals, the maker of Prempro® to recall the defective drug.
Baycol® Defects Outweigh Benefits
Baycol®, a prescription drug used to lower people’s cholesterol levels was recalled from the U.S. market in August 2001 due to numerous deaths associated with its use. Baycol®, produced by Bayer Pharmaceutical, is a statin drug that was supposed to reduce the risk of heart failure by suppressing cholesterol manufacture in the body. Unfortunately, taking Baycol® regularly was also linked to the occurrence of rhabdomyolysis in many patients. Rhabdomyolysis is an acute and potentially fatal disease that destroys skeletal muscle and causes severe muscle pain and fatigue. Reports of serious side effects of Baycol®, including death were over 10 times more frequent than other statin drugs. At the time of its recall, over 100 Baycol®-related deaths had been report to the FDA.
Rezulin® Recalled
Rezulin® was approved by the FDA in 1997 to treat the effects of Type II diabetes, which is the most common form of the insulin disorder. Diabetes is an affliction that hinders the body’s ability to regulate sugar levels in the blood. When Rezulin® was created, it was the first medication to effectively manage insulin production and was viewed as the answer to the debilitating complications of diabetes. Because Rezulin® promised such hopeful results the FDA quickly ushered Parke-Davis, the drug’s manufacturer, through the approval process. By the time Rezulin® was recalled just three years later in 2000, nearly 400 people had died and hundreds of patients experienced severe liver damage. Category Archive | Find a Lawyer
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