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FDA says three atypical antipsychotic medications may be effective in children, but carry risks.

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The Wall Street Journal (6/5, Dooren) reported that on June 5, staff from the Food and Drug Administration (FDA) said that three medications "currently approved to treat bipolar disorder and schizophrenia in adults were effective at treating the disorders in children and adolescents, but carry significant risks." The FDA is now "considering applications for AstraZeneca PLC’s Seroquel [quetiapine] and Eli Lilly and Co.’s Zyprexa [olanzapine] to treat bipolar disorder and schizophrenia in children and adolescents, and Pfizer, Inc.’s Geodon [ziprasidone] to treat bipolar disorder in children 10 to 17." On June 9-10, "an FDA panel of outside medical experts is scheduled to meet to discuss" these atypical antipsychotics, and will be "asked to vote on whether each product is safe and effective for children ages 10 to 17." According to the agency and the pharmaceutical makers, "studies showed the products were effective at treating the symptoms of bipolar and schizophrenia," but "all had side effects," including "sedation and weight gain."

The AP (6/6, Perrone) added that the "FDA released its review of the three drugs ahead of a meeting Tuesday where outside experts will weigh in on the" medications’ "risks and benefits. The agency is not required to follow the group’s advice, though it usually does." On Friday, "FDA reviewers said…they were wary of exposing youngsters to the" medicines’ "side effects, including weight gain and high blood sugar, ‘because they may be exposed for many decades.’" In documents posted online, Thomas Laughren, MD, FDA director for psychiatric products, wrote, "These risks are of particular concern in pediatric patients because of the lifelong nature of these disorders." Currently, some physicians "already prescribe the medications to children and adolescents, although regulators have not officially cleared that use."

According to Bloomberg News (6/6, Larkin), atypical antipsychotics "were introduced for adults in the mid-1990s and touted having fewer neurological side effects than older" medications. For years, the FDA "grappled with pediatric use…because of concerns that the weight gain, sleepiness, and movement disorders reported as side effects in adults may be more pronounced in children." Therefore, the agency "asked its Psychopharmacologic Drugs Advisory Committee to vote whether the companies’ studies prove their products are effective and ‘acceptably’ safe for the pediatric uses being sought." Bloomberg News pointed out that "more than half of the 589-page staff review posted" Friday focused "on Zyprexa, Lilly’s biggest product, with $4.7 billion in sales last year."

In the Wall Street Journal (6/5) Health Blog, Shirley S. Wang observed, "Recent studies of effectiveness have shown that the antipsychotics aren’t as good as previously believed." In an email to the Health Blog, Thomas Insel, MD, director of the National Institute of Mental Health, wrote, "They reduce some symptoms for some people, but they help too few people recover." Dr. Insel went on to explain that "using antipsychotics in children is a ‘tough balance’ between the risk vs. the benefits of the medicines." Specifically, "with current antipsychotics you risk either metabolic side effects or neurological side effects," Dr. Insel said, emphasizing that "in children, the balance needs to favor minimizing risks." As of right now, "only two antipsychotics, J&J’s Risperdal [risperidone] and Bristol-Myers’s Abilify [aripiprazole], are approved for use in children," Wang noted.

6 Comments

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    Eli Lilly Zyprexa can cause diabetes

    I took Zyprexa a powerful Lilly schizophrenic drug for 4 years it was prescribed to me off-label for post traumatic stress disorder was ineffective costly and gave me diabetes.
    This is a powerful drug that can damage a young person physiologically for life.

    Please take with caution and learn as much as you can about side effects.
    Eli Lilly’s #1 cash cow Zyprexa drug sale $38 billion dollars so far,has a ten times greater risk of causing type 2 diabetes over the non-user of Zyprexa.
    So,here we have a conflict of interest that this same company also is a big profiteer of diabetes treatment.

    Daniel Haszard

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    Thanks for this information. How can we get the word out on these traps for the unwary?

  3. Sailingwindward says:
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    Follow the money trail from AstraZeneca and other pharmaceutical companies to congressional campaign contributions and the answer will be clear as to why the FDA has been approved so many unproven drugs to children.

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    Do you have any suggestions about other resources, or sources, on the internet where we can shine the light on drugs like Zyprexa and companies that make them? I am looking for connections on these important health issues. Why can’t we put some pressure on Congress and the corporations?

  5. Sailingwindward says:
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    Wayne, The information is a matter of public record (well hidden public record), it takes lots of time, research, willingness and sometimes money to get the information needed. Part 2 getting the info out to people, the media, blogs, youtube, etc. Part 3 getting those people to pressure congress.
    I have followed the money in both the Enron-Loophole and the Medicare prescription drug plan and it’s dam ugly what happened in all cases this was outright bribery from the lobbyists to the congressmen in any other circumstance this would fall under the Federal RICO act on organized crime, and yet to date the Enron-Loophole is not closed all the way which is why gas & oil are going so high lately.

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    I like the concept of using social technology to take these issues to the people.That is one of my goals with this Blog. I am always interested in people who want to do something. I guess I’ll keep getting stories like this one out in my Blog and trying to collaborate with others who want to stir things up.