Eli Lilly & Co.has had an FDA expert panel meeting canceled over its application to expand the use of its antidepressant, Cymbalta.
Abilify by Bristol Myers Squibb was just approved by the FDA for treatment of autism-related irritability and acting out. It is among a group of antipsychotics that cause weight gain in users.
Atypical antipsychotics used in young patients for the first time led to a weight gain of anywhere from 11 to 19 pounds in just 11 weeks and an increase in cholesterol and triglycerides, making some question whether the drugs are a long-term solution for young people with psychiatric disorders.
While Risperdal is already approved for use in adolescents, three other makers of powerful atypical anti-psychotics are seeking FDA approval for use in the young. The drugs are effective in some, but others say they can be fatal and are known to cause weight gain and increase the risk of diabetes.
When seven-year-old Gabriel Myers hanged himself in a foster care home, Florida immediately conducted an audit on how many kids, like Gabriel, were on mind-altering drugs. Up to three times the general population are put on psychiatric drugs with the numbers increasing to one-in-three among teens in group homes.
When Florida began requiring physicians to obtain approval from the state before prescribing antipsychotics to children under the age of six, something dramatic happened - prescriptions dropped 75 percent. The same trend is being seen nationwide.
In one of the largest imaging studies on whether depression runs in families - researchers find that a thinning in the right hemisphere of the brain appeared to be linked to a risk of depression.
Symbyax will be used for patients who have bipolar depression that is resistant to treatment. It also helps Lilly get around the patent expiration for Prozac.
Eli Lilly will have to pay the federal government more than $1.4 billion to settle an off-label marketing scheme for its prescription drug, Zyprexa. The settlement is the largest amount paid by a single defendant in the history of the Department of Justice and was initiated by six former Lilly drug marketing representatives who became whistleblowers over the aggressive off-label marketing for the antipsychotic.
If schizophrenia runs in a family, bipolar disorder most likely does as well (and vice versa), suggests new research. A new study, published online in the January issue of the journal The Lancet, suggests both disorders share common genetic causes.
In a routine pediatric safety review on Tuesday, an outside panel of experts unanimously requested more long-term data on the side effects of prescribing powerful antipsychotic drugs to children including Risperdal and Zyprexa.
Seroquel's new extended release formula will have an extended patent, and presumably bring expanded profits for AstraZeneca, despite the controversy about the drug's side effects.
A federal district court judge granted a motion to unseal hundreds of confidential documents about Zyprexa, Eli Lilly’s popular antipsychotic drug. The decision came as part of another ruling granting class-action status to a case brought by pension funds, labor unions and insurance companies that want Eli Lilly to reimburse them for millions of dollars overspent on Zyprexa.
Published studies uncover a genetic component to schizophrenia that had never before been seen. For a disease that has seen few breakthroughs, these discoveries will help target therapies and earlier diagnosis.
With a new stronger authority, the FDA will now mandate that the conventional antipsychotics carry the same black box warning as atypical antipsychotics, used on elderly patients with dementia to quiet agitation, and behavioral problems.
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