Maker Pushed Zyprexa for Dementia, Without Evidence: Report
The maker of the anti-schizophrenia drug Zyprexa allegedly marketed the drug for "off-label" use in patients with dementia, despite lacking evidence that it worked for that purpose, the Bloomberg news service reported Friday, citing internal company documents.
Some four years after Eli Lilly & Co. told the U.S. Food and Drug Administration that its studies found no evidence that Zyprexa helped elderly dementia patients, in 1999 the company began pitching the drug for use in such patients, Bloombergreported.
In fact, the studies found that elderly people with Alzheimer's disease and other forms of dementia who took Zyprexa faced a "significantly greater" risk of death than those who didn't take the drug, according to the news service.
In 2005, the FDA began requiring warning labels on Zyprexa and similar "antipsychotics," noting that the drugs increased the risk of death among elderly dementia patients, Bloomberg said.
Lilly's documents have been released as part of lawsuits against the drug maker by insurers and pension plans, according to Bloomberg. The plaintiffs are seeking up to $6.8 billion in damages, alleging the company ignored the drug's health risks and marketed Zyprexa for off-label use to increase sales.
Lilly pleaded guilty earlier this year to a federal misdemeanor charge of pitching the drug for off-label use for seniors with dementia. Lilly conceded illegally marketing the drug from September 1999 through March 2001, but has denied claims beyond that date. A company spokeswoman accused those bringing the lawsuits of "releasing one-sided cherry picked documents obtained in discovery to selected news media in an effort to try their case in the media," Bloombergreported.
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Gout Drug Effective, Despite Dangers: FDA
A new drug for gout appears effective in treating the disease, despite potential cardiovascular side effects, the Associated Press cited the U.S. Food and Drug Administration as saying on Friday.
About one-quarter of clinical trial participants who took Krystexxa had a serious adverse effect, versus 12 percent of those who took a non-medicinal placebo. Six deaths were reported among those who took the drug, compared to three deaths among those who didn't. But the FDA "noted that many of them had pre-existing heart conditions," the wire service reported.
The agency has been reviewing the approval application from the drug's maker, Savient Pharmaceuticals, since December, the AP said. On Friday, the agency said the drug seems to relieve gout's symptoms, primarily painful swollen joints. The condition, affecting some 8 million Americans, is caused by the body's buildup of too much uric acid.
On Tuesday, an FDA panel of experts is set to announce whether it will recommend approval of the drug. The full agency isn't bound by the recommendations of its expert panels, but usually follows them. The full agency's decision is expected by the end of next month, the AP said.
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Nursing Deficit Shrinks, With Economy's Help
The shrinking economy is helping to restore a withering nursing pool in the United States, easing a decade-long shortage of hospital nurses, the Wall Street Journalreported Friday, based on a new study's findings.
The number of nurses entering the workforce shot up by 243,000 (18 percent) in 2007-2008, the largest two-year rise in 30 years, the newspaper said. Many nurses who had left the profession -- about half of them older than age 50 -- returned for reasons including making up for a partner's lost income or acquiring health benefits, according to the study published Friday in the journal Health Affairs.
The shortage began in about 1998 and topped out in 2001, when some 13 percent of the average hospital's nursing needs were unmet, the Journal said.
In addition to the souring economy, other factors helping to restore the nursing pool included expanding nursing schools, efforts to attract young candidates and a jump in foreign-born nurses, the newspaper reported.
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Injected Ibuprofen Gets FDA Approval
Caldolor, the first injected form of ibuprofen, has been approved by the U.S. Food and Drug Administration to treat pain and fever, the agency said in a news release.
The drug will be available only for hospital use in 400 milligram to 800 milligram doses, depending on whether the patient has acute pain or fever. It's particularly useful for patients who cannot take ibuprofen in its oral form, the agency said.
Clinical testing involving 319 women who had undergone an elective hysterectomy found they were much less likely to ask for morphine if given Caldolor. Nausea, flatulence, vomiting and headache were the most common adverse reactions.
The drug is produced by Tennessee-based Cumberland Pharmaceuticals Inc.
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