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Diabetes Drugs and Heart Risk

New Studies Link Avandia, but Not Actos, to Heart Attacks

Actos, Avandia: New Drug Class, New Side Effects continued...

Solomon notes that no drug is absolutely safe.

"Actos and Avandia are very potent at reducing blood sugar, and people with diabetes need something," he says.

Solomon argues for deep change in the FDA's drug approval process:

  • Early safety concerns should trigger "strong and clear regulatory actions."
  • As a condition of drug approval, manufacturers should commit to timely postmarketing surveillance studies or randomized clinical trials in high-risk patient groups not included in the earlier clinical efficacy studies.
  • After several drugs are approved for an indication, new drugs must be approved based on solid clinical endpoints (reductions in disease or death) rather than on markers such as blood sugar levels.
  • Continued marketing of a drug should hinge on whether that drug proves as safe and effective as it seemed when approved.
  • The risk-benefit calculation for every drug should be clearly defined so that it is obvious when a drug's risks outweigh its benefits.

The Singh and Lincoff studies, and the Solomon editorial, appear in the Sept. 12 issue of the Journal of the American Medical Association.

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