Heart Drug Recalled Over Patients’ Complaints of Chest Pains
For years Dr. Harry Lever, a cardiologist, had warned his patients about the heart drug metoprolol succinate, the generic version of the popular Toprol XL. Many of his patients complained about chest pains and other symptoms while taking the drug, but as soon as he switched them from metoprolol succinate to another heart drug, their symptoms were relieved. Dr. Lever, propelled by the many complaints of his patients, decided to draw the attention of the FDA by writing a letter to the agency and later traveling to Washington DC to stand in front of Congress. Unfortunately, Dr. Lever did not get the response he wanted but feels some vindication has two Indian pharmaceutical companies recently recalled over 100,000 bottles of metoprolol succinate for its failure to properly work to control high blood pressure.
Indian Pharmaceutical Companies Face Chronic Lack of Oversight of Drugs
This isn’t the first time that an Indian company has been forced to recall a generic drug in the past few years. In fact, some Indian companies have been banned permanently from exporting products to the U.S. Specifically, Wockhardt was recently banned when the FDA found terrible conditions in the company’s manufacturing plant. Nevertheless, the recall of metoprolol succinate represented just a small fraction of the total number of prescriptions for the drug in 2013. For concerned doctors like Dr. Lever, this isn’t enough action towards protecting patients from dangerous consequences of taking some poorly regulated generic drugs, particularly those deriving from India. The FDA says that it is currently investing the generic drug market, which represent 80% of the total prescription drugs prescribed each year. However, despite the investigation the FDA says that it maintains its long-held position that generic drugs are safe and effective.
Doctor Takes Matters Into His Own Hands to Protect Patients from Harm
Some have described the FDA’s investigation and regulation of generic products a “black box” because no one is quite sure of the decision making process behind the approval of certain drugs. However, Dr. Lever is not taking any risks with his heart patients and warns them to avoid Indian-based heart medications because of the experiences of many of his patients. Although the FDA is an important agency charged with the task fo protecting patients from harmful drugs, the agency must also open its “black box” to gain the assistance of doctors and other medical professionals and experts who know firsthand the dangers of some generic drugs.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.