Word: rezulin
(lookup in dictionary)
(lookup stats)
Dates: all
Sort By: most recent first
(reverse)
Consider what happened with Rezulin, the diabetes drug that was taken off the market last week. The FDA approved the medication in 1997 after tests on 3,000 people showed that it could help control Type 2 (formerly adult-onset) diabetes, which affects 15 million Americans. Although some test subjects developed abnormal liver reactions, no one suffered permanent damage, and no one died. Now that millions have taken Rezulin, however, it has been linked to at least 90 cases of liver failure, 63 of which resulted in death...
When serious complications first started showing up, the FDA strengthened the warning labels on Rezulin and recommended regular liver tests for all patients using it. But not everyone got tested, and it was impossible to predict who would suffer a bad reaction. Then last year the FDA approved two new drugs (Actos and Avandia) that are chemically related to Rezulin but appear to be safer. Rezulin began looking like more trouble than it was worth...
...been a tough week for the Food and Drug Administration. On Tuesday, the Supreme Court dealt a decisive blow to the agency's authority, ruling the FDA does not have regulatory power over tobacco. And Wednesday, after the diabetes drug Rezulin was linked to 63 deaths and 90 cases of liver failure, the FDA finally convinced pharmaceutical giant Warner-Lambert to pull it from the market. The agency will face inevitable questions: Why would the FDA approve a drug with known toxic side effects? Can consumers trust their safety to the agency's testing standards...
...important to know the history of Rezulin before leveling any charges, says TIME medical writer Christine Gorman. "All prescription drugs have risks and benefits, and Rezulin was no different," she says. "Patients with liver problems had to be watched very carefully while taking this drug, but it helped a lot of people with diabetes." And that cost-benefit ratio played into the FDA's timing; the agency did not pull Rezulin until other, less toxic drugs became available...
...that clearly wasn't enough. Though the panel decided to keep Rezulin on the market, its thumbs-up came with a warning to the FDA to limit the drug's use to patients who are failing other treatments. And the ruling made it clear, implicitly at least, that without adequate follow-up, the agency's streamlined approval process could be a fast track to disaster...