Generic Drugs Save Money But Do They Save Lives?Posting Date: 07/19/2004 Generic drugs are frequently offered as a solution to the high cost of prescription medicine. They are supposed to be identical to their brand name counterparts. But how good are they, really? The FDA maintains generics are excellent. For decades we agreed and recommended them. The federal agency has stringent guidelines before brand name substitutes are approved. But once a generic makes it to market, there is limited follow-up to ensure quality control. The agency analyzes about 300 ?finished dosage forms? annually, including both branded and generic medicines. That comes to about 0.00001 percent of the 3 billion prescriptions filled in community pharmacies annually. The FDA would have to get very lucky to detect a problem based on such a small sample. Instead, the agency counts on physicians, pharmacists and patients to report problems. Despite assurances, many readers have reported difficulties with generic drugs: ?Several years ago I was diagnosed with persistent atrial fibrillation. My doctor prescribed Betapace, which controlled the irregular heartbeat beautifully. ?Recently, however, I ran out of my usual mail-in prescription. I got a new prescription from my cardiologist and had it filled at the local pharmacy (a 30-day supply to tide me over). ?I did not request the brand name, so the prescription was filled with generic sotalol. Soon my heartbeat became so erratic that I went to see my cardiologist. She had me wear an event monitor for 30 days to see what was happening. ?During that time my regular prescription for Betapace arrived, and I switched back from the generic to the brand name drug. My erratic heartbeat went back to its usual nice steady rhythm almost immediately. When I returned to the doctor, she agreed the whole thing was probably due to the generic substitution.? Related Stories |
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