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Two Firms Ordered to Stop Making Unapproved Nitroglycernin Tablets

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Millions of heart patients have been treated with unapproved nitroglycerin tablets. Earlier this month, the Food & Drug Administration (FDA) ordered Konec Inc. and Glenmark Generics Inc. to stop making and shipping the unapproved drugs.

Drug makers like Konec and Glenmark have marketed unapproved drugs for years, claiming they were grandfathered in when the FDA was established in 1938. However, the FDA disputes this interpretation. According to a report in The New York Times, the agency has recently been cracking down on such drugs.

On March 16, the agency sent warning letters to Konec and ordering them to stop producing the unapproved nitroglycerin tablets within 90 days, although they can continue to ship them for another six months.

Nitrostat, made by Pfizer, is the only nitroglycerin pill currently on the market that has FDA approval. According to the Times, Pfizer expects to be able to meet the entire U.S. demand for nitroglycerin tablets.

The FDA has not asked Konec or Glenmark to recall the unapproved nitroglycerin tablets. According to The New York Times, some major pharmacies, including CVS and Walgreens, plan to continue selling the drugs because the FDA warning letter stipulated that the nitroglycerin could continue to be shipped for another six months.

Nitroglycerin tablets are placed under the tongue to reduce chest pain in angina or to stop a heart attack. Taking an ineffective or defective nitroglycerin tablet could cause angina to progress to a heart attack. At least four million prescriptions – close to 80% of all those written – were filled last year for nitroglycerin tablets that were not approved by the FDA.

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