Patients who take nitroglycerin tablets may ask whether they are receiving an unapproved brand subject to recent FDA action, as reported in the New York Times on Friday. The FDA sent warning letters to two major manufacturers of unapproved nitroglycerin: Konec, Inc. and Glenmark Generics, Inc. The drugs are not being recalled; the manufacturers have 180 days to stop shipments.
According to the article, some manufacturers previously argued that they didn't need approval because nitroglycerin was available before the FDA was formed. The FDA says the drugs need prior approval and that some unapproved versions have "significant quality and efficacy problems." Only Pfizer has FDA approval to market nitroglycerin tablets.
The FDA recommends patients continue taking their nitroglycerin tablets but contact a physician to discuss treatment options.
New York Times story (Free)
FDA's Q&A on unapproved nitroglycerin tablets (Free)
FDA news release (Free)
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