The medication - sublingual nitroglycerin tablets - is placed under the tongue to relieve chest pain or to stop a heart attack. Some 80 percent of the 4.4 million prescriptions written in 2009 were filled with unapproved drugs, according to a national healthcare research firm.
Food and Drug Administration (FDA) officials stated the unapproved nitroglycerin tablets have not been proven safe and effective, and the FDA has not reviewed the quality and labeling of these products. Without naming any manufacturers, the statement also said the FDA has seen significant quality and efficacy problems with some unapproved nitroglycerin products.
“If it’s not approved and no one has tested it, we can’t be sure that it’s safe and effective,” Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic, said in an interview with The New York Times. If patients with angina took substandard or ineffective nitroglycerin tablets, Lever said, their pain might not subside and the problem could potentially progress to a heart attack.
Pfizer Inc. markets the single federally approved nitroglycerin pill, Nitrostat, which has been available since 2000, and has agreed to increase production. The FDA plans to work with patient organizations and health professionals to ensure they’re aware an approved product is available.
Consumers are being advised by the FDA to continue using the unapproved products and to consult their doctors about replacement prescriptions. The FDA is not issuing a recall, the products will remain on drug store shelves and continue to be sold.
Warning letters have been sent to the two leading suppliers of the unapproved drugs, Konec Inc. of Tucson, Ariz., and Glenmark Generics Inc. of Mahwah, New Jersey, giving them 90 days to stop making the drugs and six months to stop shipping them. Konec Inc. has stated the company will take the steps needed to follow the FDA approval process. The Mubai, India–based parent firm of Glenmark Generics has stated the company will stop manufacturing unapproved nitroglycerin tablets.