DrugBuyers.Com: Health Risks of New Anti-Psychotic Meds

The diabetes is probably a consequence of the weight gain and while it is a more serious side effect than obesity, diabetes can take quite a while to develop and would probably not be found in any Phase III trials prior to drug approval. FDA's Phase IV is monitoring for adverse side effects while a drug is in use. That is where they should notice the diabetes risk. Weight gain was observed in the Phase III trials.

The FDA often accepts known side effects in approved medications by balancing harm against benefit. I was told by a M.D. in 1999 that Respirdal causes less weight gain than Zyprexa ... which matches what this article says. If the diabetes risk is confirmed, FDA will probably change the product insert warnings and advise doctors to screen these patients for diabetes. Diabetes is a slow-developing side effect. Weight gain would usually be a warning signal. These side effects are much less of a health threat than things that can cause sudden death. The second generation antipsychotics will stay on the market because weight gain and an increased risk of diabetes are nothing compared to the irreversible neurological damage that was often seen with the first generation antipsychotics, and the new drugs have allowed many people with schizophrenia to hold steady jobs instead of sitting at home on disability as they did with Thorazine.

Compare this to the phen-fen situation where drugs used to treat obesity were found to sometimes cause sudden death. That was unacceptable from a harm/benefit perspective.

Here the benefits almost surely outweigh the risks, which are slow-developing in any case and possibly preventable. It's a simple matter to monitor the weight gainers for diabetes and try to prevent diabetes with diet and exercise. Unlike the laboratory blood tests for liver function needed for many drugs, diabetes screening can be performed with simple tests in most any doctor's office.

There are surely very few drugs with no known adverse side effects. I can't think of one.

Trampy

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