Accident & Injury Law in Texas

Doctors in the United States wrote more than 4 million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce the chest pain of angina or to stop a heart attack.

But the majority of the drugs sold had not been approved for sale or had their safety and effectiveness vetted by the Food and Drug Administration.

And many doctors, who discovered only last week that pharmacies were giving their patients unproven heart tablets, now say they have no way of knowing whether patients have suffered unnecessarily as a result.

The problem of the unapproved tablets stems from a longstanding ambiguity about the rules for drugs whose use predates the establishment of the FDA in 1938. Only one brand of nitroglycerin pills is federally approved: Nitrostat, made by Pfizer, on the market since 2000.

The FDA sent warning letters to two drugmakers ordering them to stop marketing unapproved nitroglycerin tablets. But the drugs are still being sold at pharmacies while the order takes effect.

The drugmakers said they would comply with the order but said that their tablets were safe.

The FDA said that it had not examined the quality of the products it was ordering off the market but that it had recorded problems with other unapproved nitroglycerin products in the past.

People who take unapproved nitroglycerin are advised to continue taking their tablets but to consult their doctors about replacement prescriptions.

Cardiologists regularly prescribe nitroglycerin to relieve chest pain associated with coronary artery disease. Placed under the tongue, the drug quickly dissolves into the blood, where it dilates the coronary artery, slightly decreasing blood pressure and reducing heart exertion.

When taken during an initial episode of chest pain, nitroglycerin can prevent a heart attack in 3 to 4 percent of patients, said Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic.
Many makers of various drugs, not only nitroglycerin tablets, have long contended that their medications did not require FDA review because they were grandfathered as pre-1938 drugs. But the agency is now disputing that interpretation.

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