corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism Library item: 18598

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Perrone M
FDA Questions Wider Approval of Lilly's Cymbalta
ABC News 2010 Aug 17
http://abcnews.go.com/Business/wirestory?id=11417988


Abstract:

FDA questions whether Lilly’s antidepressant Cymbalta is safe and effective for chronic pain


Notes:

(See also:
Drug Secrets: What the FDA isn’t telling.
http://www.slate.com/id/2126918/#sb2126921Traci)


Full text:

Federal health scientists are questioning whether the antidepressant Cymbalta is safe and effective enough to be approved for use against chronic pain.

The Food and Drug Administration on Tuesday posted its review of Eli Lilly and Co.‘s application to market the drug for a range of pain ailments, including lower back pain. But FDA reviewers appeared cautious about further expanding use of a powerful psychiatric drug already used by nearly 15 million patients.

FDA reviewers raised questions about the statistical methods used to study the drug and its liver side effects.

The drug is already approved to treat depression, diabetic nerve pain and fibromyalgia.

The FDA will ask a panel of outside experts on Thursday to consider whether Cymbalta should be approved for chronic pain.

Eli Lilly has been trying to gain approval for the new indication for more than two years. The company withdrew its FDA application in November 2008 after agency evaluators questioned the method and design of some of the company’s trials. The company resubmitted its application last summer with new data on Cymbalta’s use against pain caused by osteoarthritis.

Three studies submitted by Lilly showed that Cymbalta lowered patient-reported pain scores significantly more than placebo after three months.

But in its review posted online, FDA scientists said Lilly’s methodology still appeared “problematic.” Specifically, the company included positive feedback data from patients who later dropped out of the study, possibly because of side effects to the drug. According to FDA reviewers, this practice could “potentially assign good pain scores to subjects who could not tolerate the drug.”

The FDA also has concerns about widening use of a drug associated with serious liver toxicity. Cymbalta already carries a warning label about liver toxicity risks based on more than a dozen reports from patients taking the drug.

According to FDA records, use of Cymbalta has already expanded threefold from 5 million in 2005 to 14.6 million last year as the drug has picked up additional indications.

The agency will ask its panel of advisers to discuss the safety of further expanding the drug’s use. The FDA is not required to follow the group’s advice, though it often does.

A spokeswoman for Indianapolis-based Lilly said in a statement “we are confident in our data package, which is based on studying Cymbalta in more than 2,600 patients … and we look forward to discussing our data with the committee.”

Cymbalta is part of a class of drug called serotonin-norepinephrine reuptake inhibitors, which include antidepressants Effexor and Pristiq. The mechanism of action that allows Cymbalta to decrease pain is not entirely understood, though the company says it likely involves the brain chemical serotonin, which affects mood.

If approved, it would be the first antidepressant cleared for chronic pain.

The drug was Eli Lilly’s second best seller last year with sales of $3 billion, behind the anti-psychotic Zyprexa.

Shares of Lilly fell 86 cents, or 2.4 percent, to $34.71 in midday trading. In a separate development Tuesday, the company announced it would abandon studies of a potential Alzheimer’s disease treatment because patients taking the drug fared worse than those on a placebo.

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others.

Email a Friend








Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909