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Generic Version of Heart Drug, Toprol XL, Recalled

Jun 25, 2014

A cardiologist at the renowned Cleveland Clinic has long warned of problems with the generic version of the heart medication, Toprol XL. In the past two months, Indian-manufactured, generic versions of the drug have been recalled. Generically, the medication is known as metoprolol succinate.

Dr. Harry Lever told The New York Times that he has been warning people against using generic versions of Toprol XL after patients taking the generic version began complaining of chest pain and other symptoms following a switch from the AstraZeneca brand version. Typically, the generic versions involved were made in India and, when patients were switched back to the brand or another generic version, their symptoms disappeared, according to Dr. Lever.

The physician wrote about his concerns to the U.S. Food and Drug Administration (FDA) in 2012 and, in 2014, he went to Washington D.C. to try to gain Congressional assistance. Although he has not been able to definitively prove the generics are to blame, he told The New York Times, “You see enough people and you get a feel, but it’s anecdotes…. It’s not science.” Toprol XL, and its generics, is a beta-blocker prescribed for the treatment of high blood pressure and cardiac issues.

Now, two of India’s larger drug makers, Wockhardt and Dr. Reddy’s Laboratories, have both announced recalls of generic Toprol XL in the past two months, according to Reuters. In both cases, the medications were not dissolving properly, which means that they were likely not working as they should, wrote the The New York Times. Wockhardt is now banned from exporting drugs to the United States that were manufactured in two of its India-based plants where inspectors from the FDA discovered significant issues.

The FDA is looking into the quality of generic medications, which comprise most—80 percent—of all U.S. prescriptions, noted The U.S. Food and Drug Administration. Meanwhile, FDA commissioner, Dr. Margaret A. Hamburg, visited India to discuss her worries associated with drug safety and India-manufactured drugs. The agency is also looking at all extended-release products as they are more challenging to manufacture and, in early 2014, the FDA asked researchers to review the efficacy of generic Toprol XL, according to The New York Times.

“The doctors in this country need to know what’s going on, because we’re ultimately writing the prescriptions and we’re responsible,” Dr. Lever said. “There’s been this assumption that one generic is the same as another. Not in this case,” he told The New York Times.

Christopher C. Kelly, FDA spokesman, acknowledged in a statement that “there have been challenges in consistently manufacturing” metoprolol succinate. Kelly said the FDA had routinely monitored manufacturing of metoprolol succinate and that, in 2013, the agency conducted a “multidisciplinary investigation” of the efficacy and quality of every version of the drug in the U.S. According to the agency, every version, including the two recalled versions, were—at that time—bioequivalent to the brand version.

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