80% of nitroglycerin scripts are filled with ‘unapproved’ pills

Several million cardiac patients have been taking pills never approved, or tested for safety, by the FDA.

Of the 4.4 million prescriptions for nitroglycerin written last year, an estimated 80% were filled with pills manufactured by companies not authorized to do so.

The only federally approved brand of nitroglycerin is Pfizer’s Nitrostat. Earlier this month, the FDA sent warning letters to two pharmaceutical makers, Glenmark Generics and Konec, giving them 90 days to cease production of the drug, and 180 days to stop shipping the product. Glenmark and Konec are the two largest suppliers of unapproved versions of nitro.

How could this happen? It stems from differing interpretations of an ambiguous rule.

Unauthorized manufacturers of nitroglycerin and other medications say the drugs are exempt from FDA review because they predate the 1938 Food, Drug & Cosmetic Act. The FDA rejects that notion.

So far, Konec has said it will conduct FDA-required bioequivalence tests and seek to have its drug approved as a generic. Glenmark said it’ll comply with the FDA’s request to cease production of the drug.

No shortages are expected. Pfizer said it has stepped up production of the approved version in order to meet expected increases in demand.

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