Evaluating the Safety of Diabetes Drugs.
- Resource Type
- Article
- Authors
- Misbin, Robert I.
- Source
- Diabetes Care. Oct2005, Vol. 28 Issue 10, p2573-2576. 4p.
- Subject
- *DRUG development
*PHARMACOLOGY
*PHARMACY
*CLINICAL trials
*PLACEBOS
- Language
- ISSN
- 0149-5992
This article describes the process by which the U.S. Food and Drug Administration (FDA) evaluates safety data relating to diabetes drugs. Problems had been facing FDA for years. In 2004 came the recognition that widely used antidepressants were associated with suicide in young patients, and then came the withdrawal of Vioxx. Drugs in diabetes and metabolism have not been spared. The obesity drug Meridia and the lipid-lowering agent Crestor are two of the five drugs whose safety was challenged by FDA epidemiologist Dr. David Graham in testimony before a U.S. Senate committee. Unique among drug withdrawals is the diabetes drug phenformin, which was declared an imminent hazard and was removed from the market in 1977 because of lactic acidosis. One lesson that should be learned from these examples is that it is hazardous to make firm conclusions about the safety of a new drug. The approval of a new drug is based on safety data from a few thousand patients treated under the intense medical supervision of a clinical trial. Diabetes drugs have typically been approved based on trials involving a few thousand patients. Although some important information is derived from short-term trials, the most important pre-approval safety data come from results of phase 3 trials. These trials generally last from 16 to 52 weeks and compare various doses of the test drug to placebo or to another drug that has already been approved. Phase 3 trials are useful for identifying safety issues that are reasonably common but not large enough to detect adverse events that are rare. In many cases, phase 3 trials generate signals that need to be evaluated further. The FDA may require that approval of a new drug be contingent on the manufacturer's commitment to do additional safety studies after approval.