U.S. lawmakers should investigate the Food and Drug Administration's handling of side effects linked to Eli Lilly's antipsychotic medication, Zyprexa, an agency whistleblower said on Tuesday.
FDA scientist Dr. David Graham told a congressional hearing the drugmaker and the agency knew "for a long time" about the risk of weight gain from Zyprexa that could trigger diabetes.
While such side effects were eventually added to the drug's prescribing instructions, Graham testified it was not clear how the agency handled the information or made the decision to alter the label.
"FDA did its typical dragging its feet on post-marketing safety issues," he told Reuters after the U.S. House of Representatives Energy and Commerce subcommittee hearing.
Graham did not review Zyprexa, but said that, after his 2004 public testimony criticizing the FDA's actions on Merck'w withdrawn Vioxx painkiller, other agency staffers came to him with concerns.
More at Reuters
FDA scientist Dr. David Graham told a congressional hearing the drugmaker and the agency knew "for a long time" about the risk of weight gain from Zyprexa that could trigger diabetes.
While such side effects were eventually added to the drug's prescribing instructions, Graham testified it was not clear how the agency handled the information or made the decision to alter the label.
"FDA did its typical dragging its feet on post-marketing safety issues," he told Reuters after the U.S. House of Representatives Energy and Commerce subcommittee hearing.
Graham did not review Zyprexa, but said that, after his 2004 public testimony criticizing the FDA's actions on Merck'w withdrawn Vioxx painkiller, other agency staffers came to him with concerns.
More at Reuters
1 comment:
It isn't just Zyprexa though. It's also Seroquel and Risperdal, though Risperdal to a lesser extent. I have been on Seroquel for bipolar disorder since 2001, before it was even approved for that illness. I have gained quite a bit of weight and have to have a diabetes test every year. The only problem with Zyprexa, Seroquel, and Risperdal is that there aren't really viable alternatives. Sure there's Geodon, but that's been proven to make most people worse instead of better, even though it was billed as a miracle drug when it came out. And Abillify is new, but in bipolars it can cause mania, not prevent it. Or you could go old school and try Haldol, Thorazine, or Clozapine, but those have not been proven to work on bipolar disorder, and their side effects are just as bad, if not worse, than Zyprexa et al, in most cases. The mentally ill are caught in the middle. Do we worry about weight gain and diabetes or do we worry about tardive diskenesia and other similar side effects in addition to being so drugged you cannot function? Personally, I choose to worry about diabetes. That is treatable. Once you get tardive diskensia there is no going back.
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