FDA says millions got unapproved heart pills

Doctors in the United States wrote more than four million prescriptions last year for nitroglycerin tablets, heart drugs placed under the tongue to reduce the chest pain angina or to stop a heart attack. But the majority of the drugs sold had not been approved for sale, nor had their safety and effectiveness been vetted, by the Food and Drug Administration. And many doctors, who discovered only last week that pharmacies were giving their patients unproved heart tablets, now say they have no way of knowing whether patients have suffered unnecessarily as a result. "If it's not approved and no one has tested it, we can't be sure that it's safe and effective," said Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic. If patients with angina took substandard or ineffective nitroglycerin tablets, Dr. Lever said, their pain might not subside and the problem could potentially progress to a heart attack.