FDA: Millions of Unapproved Nitroglycerin Tablets Distributed

According to an article in the New York Times, U.S. doctors wrote more than four million prescriptions for nitroglycerin tablets last year, but many of the drugs sold were not approved for sale, nor had their safety and effectiveness been determined by the FDA.

Nitroglycerin tablets are heart drugs that are placed under the tongue in order to reduce chest pain angina or to stop a heart attack. The tablets in question are manufactured by Glenmark Generics and Konec Inc. The only FDA-approved nitroglycerin tablet is marketed by Pfizer Inc.

The FDA sent letters to Glenmark Generics and Konec Inc. ordering them to stop marketing the unapproved tablets. The companies agreed to comply with the order, but argued that their tablets were safe.

According to the article, many doctors only recently discovered that pharmacies were giving their patients the unapproved nitroglycerin tablets and are concerned that patients might have suffered unnecessarily as a result. The FDA is urging patients who take the unapproved nitroglycerin tablets to continue taking them but consult their doctors about replacement prescriptions.

To view the original New York Times article, click here.