Monthly Archives: February 2008

FDA rejects injectable Zyprexa – Regulators seek more data after some side effects seen in testing

Indianapolis Star

By John Russell

Eli Lilly and Co. has hit a roadblock in its efforts to extend the life of its top-selling product, the schizophrenia drug Zyprexa, which loses its patent protection against generic rivals in three years.

The Food and Drug Administration rejected Lilly’s application to sell a once-a-month injectable version of Zyprexa, the Indianapolis drug maker said Thursday. The move surprised Wall Street, pushing Lilly’s stock down 90 cents, or nearly 2 percent, to close at $50.93.

Several analysts had expected the new form of Zyprexa would ring up robust sales in coming years to help offset the loss of daily Zyprexa, which had sales last year of $4.7 billion.

Catherine Arnold, a drug analyst at Credit Suisse in New York, had projected that long-acting Zyprexa would deliver $500 million a year in sales for Lilly starting in 2010…

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Lilly Prepares for Zyprexa Case

Associated Press

NEW YORK (Associated Press) – Eli Lilly and Co. finally heads to court next week to fight the long-standing accusation that it failed to warn doctors and patients about complications tied to its top-selling drug Zyprexa.

Lilly will face the state of Alaska in a trial in Anchorage that centers on Medicaid patients who use Zyprexa, an anti-psychotic that treats schizophrenia and bipolar disorder. Alaska is the first of nine states suing Lilly over Zyprexa to head to trial.

Alaska sued Lilly two years ago, claiming the drug maker failed to warn the state, doctors, patients and even the Food and Drug Administration about Zyprexa’s risks.

Lilly officials say the drug helps tame the most serious mental illnesses by eliminating hallucinations and allowing patients to function in society. But Zyprexa also has been linked to weight gain and high blood-sugar levels, both of which contribute to diabetes.

The state said in its complaint that Medicaid patients have suffered serious health problems after taking Zyprexa, forcing Alaska to cover additional treatment…

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Lilly Faces Initial Zyprexa Trial – Alaska’s Civil Suit Might Set Pattern for Other Actions

Wall Street Journal

By AVERY JOHNSON

Eli Lilly & Co. is set to square off next week in the first trial over its schizophrenia drug Zyprexa, defending a civil suit by the state of Alaska that will be closely watched by state and federal prosecutors investigating the drug company.

The trial’s outcome — or even evidence introduced along the way — could influence fragile settlement talks under way with the U.S. Attorney for the Eastern District of Pennsylvania and state attorneys general. An unfavorable verdict for Lilly might also embolden other states to file suit.

Plaintiffs and prosecutors have alleged for years that the Indianapolis drug maker failed to adequately warn that its powerful antipsychotic drug could lead to inordinate weight gain and diabetes. Lilly, which has sold about $35 billion of Zyprexa since its 1996 launch, has set aside $1.2 billion to settle with about 31,000 private claimants. But an additional 1,200 private suits are pending, and the company hasn’t been able to strike a deal with public-sector plaintiffs.

Alaska accuses the company of failing to warn patients of Zyprexa’s side effects, and of making deceptive claims in marketing the drug. Its 2006 complaint, filed by the state’s attorney general, also alleges that Lilly improperly marketed Zyprexa “off-label” to the state’s Medicaid recipients, costing Alaska more than it should have to reimburse patients. The state’s Medicaid program spent about $40 million on Zyprexa in the past five years, about a third of it for off-label uses…

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Cheyenne was heavily medicated-Psychiatrist testifies he prescribed three drugs at first session

Southern Standard (Tennessee)

By James Clark

Regardless of what killed Cheyenne Delp on June 26, 2004, she was a child under the influence of heavy medication the day she died.

The medicine Cheyenne was prescribed was so powerful, she had to undergo an EKG to determine if her heart was healthy enough for her to take Imipramine, a heavy duty anti-depressant.

Dr. Saran Mudumbi, who said his specialty is child psychiatry, testified Monday that he prescribed the assortment of drugs for Cheyenne because her behavior was out of control, according to her guardian, Sherri Mathis.

“She was aggressive to other children and was kicked out of school because of it,” said Dr. Mudumbi, who went on to contend Cheyenne suffered from paranoia, depression and anxiety. “She was thinking other people were against her, trying to get her.”…

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NJ Legislator: Probe Antipsychotics, Kids & Medicaid

Pharmalot 

By Ed Silverman

New Jersey’s Medicaid program spent more than $73 million on antipsychotic medications for children less than 18 years old between 2000 and 2007, according to state records, even though the drugs weren’t approved by the FDA for treating kids. And a state official acknowledges the drugs may have been prescribed for conditions other than schizophrenia and bipolar disorder, the approved uses. As a result, a state legislator is calling for an investigation and is formulating legislation.

“There are horror stories about these meds and there’s a reason they’re not prescribed for kids,” says New Jersey assemblyman Pat Diegnan, who adds that he plans to draft a bill to change the practice and to hold talks with the New Jersey attorney general’s office, which recently formed a task force to examine interactions between pharma and docs. “The entire issue is frightening and the state should be taking a closer look at this. I’m concerned about the casual prescribing by doctors and the enormous amount of money being spent.”

The disclosure comes amid growing debate over antipsychotics. At issue are fears that children are misdiagnosed; drugs are inadequately studied; some docs presribe the pills too readily, and drugmakers promote the meds improperly. As reported previously, a growing number of states are suing various drugmakers over marketing that led Medicaid programs to pay unnecessarily for the meds.

Florida, for instance, is reviewing whether antipsychotics were prescribed improperly for ADHD. “There are no studies that have shown they (atypicals) are safe, or for that matter, that they are effective for children,” Ronald Brown, a Temple University pediatric psychology professor who headed an American Psychological Association committee that examined the issue, told The St. Petersburg Times last year. “The bottom line is that the use of psychiatric medications far exceeds the evidence of safety and effectiveness.”…

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State AG sues two drug companies

Helena Independent Record

By CHARLES S. JOHNSON

Attorney General Mike McGrath has sued two national pharmaceutical companies and accused them of manufacturing certain prescription drugs that were “in defective condition and unreasonably dangerous.”

McGrath filed the complaint in state district court in Helena Wednesday against Janssen Pharmaceutica Inc. and AstraZeneca Pharmaceuticals LP over their prescription drugs Risperdal and Seroquel, respectively. These medicines were intended to treat adult schizophrenia and short-term treatment of acute mania associated with bipolar disorder.

He charged that the two companies “have engaged in false and misleading marketing, advertising and sales campaigns to promote these drugs for non-medically indicated uses.” McGrath said the companies “successfully deceived physicians, citizen-users and others in the medical community” about the safety of these drugs compared to other antipsychotic drugs in order to carve out a greater market share.

This false promotion of these two atypical antipsychotic drugs have led to some Montanans who faced “serious injuries, illnesses, diseases or death,” McGrath said.

He said the two companies illegally marketed and promoted Risperdal and Seroquel for uses not approved by the U.S. Food and Drug Administration, including treatment of dementia, sleep disorders, depression, attention deficit disorder, autism, depression, mood disorders and others.

That unlawful marketing and promotion turned Risperdal into one of the best-selling prescription drugs last year, with $4.2 billion in sales, McGrath said. Likewise, Seroquel captured 24 percent of the market in 2006, with $3.4 billion in sales to make it AstraZeneca’s top-selling prescription drug, he said…

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McGrath files suit against 2 drug firms

Billings Gazette

By CHARLES S. JOHNSON

HELENA – Attorney General Mike McGrath has sued two national pharmaceutical companies and accused them of manufacturing certain prescription drugs that were “in defective condition and unreasonably dangerous.”

McGrath filed the complaint in state district court in Helena on Wednesday against Janssen Pharmaceutica Inc. and AstraZeneca Pharmaceuticals LP over the prescription drugs Risperdal and Seroquel. The medicines were intended to treat adult schizophrenia and provide short-term treatment of acute mania associated with bipolar disorder.

He charged that the two companies “‘have engaged in false and misleading marketing, advertising and sales campaigns to promote these drugs for nonmedically indicated uses.” McGrath said the companies “successfully deceived physicians, citizen-users and others in the medical community” about the safety of these drugs compared with other antipsychotic drugs to carve out a greater share of the market.

Such promotion of the two atypical antipsychotic drugs have led to some Montanans who have faced “serious injuries, illnesses, diseases or death,” McGrath said. A spokesman for AstraZeneca said the company would have no comment on the lawsuit until it had a chance to review McGrath’s complaint. The State Bureau was unable to reach a spokesman for Janssen…

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