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.”
The record of this experience on her monitor makes it harder to dismiss as mere coincidence. Others have reported problems with certain anticonvulsants:
“My mother went on Dilantin in August, 2003. In September she was admitted to a rehab hospital. Her neurologist told them to give her only Dilantin, not a generic substitute.
“Later that month, she had four grand mal seizures and was taken to the emergency department at the hospital. When I got there she wasn’t expected to make it. The ER doctor told me that he did not think my mom had even had her Dilantin the past few days because her level was so low.
“The next day I learned she had been given generic phenytoin instead of Dilantin for the last few days. I am convinced that is why she suffered seizures.”
The FDA does not always respond to such reports. Will the agency ignore health professionals such as a nurse who works in a Coumadin clinic serving 3,000 patients? She reports that patients who are switched to generic warfarin often need more medication and are harder to stabilize.
We are all in favor of people saving money with generics, when they work. But we are interested in hearing from people who have had difficulties. You can email your story to pharmacy(AT SIGN)mindspring.com or write to People’s Pharmacy, Dept. Generic, P. O. Box 52027, Durham, NC, 27717-2027, and we will send it on to the FDA.
The People's Perspective on Medicine