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Chantix: Smoking-pill suicides overlooked in missing reports

admin » 27 May 2011 » In FDA, Legal News, Mass Tort » No Comments

Chantix: Smoking-pill suicides overlooked in missing reports

Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug’s manufacturer, submitted years of data through “improper channels.”

Some 150 suicides — more than doubling those previously known — were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices.

“We’ve had a major breakdown in safety surveillance,” said Thomas J. Moore, the ISMP senior scientist who analyzed the data. The serious problems — including reports of completed suicides, suicide attempts, aggression and hostility and depression — had been mixed among some 26,000 records of non-serious side effects such as nausea and rashes, with some dating back to 2006, the year Chantix, or varenicline, was approved.

They echo previous claims that the drug can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and sudden, violent outbursts.

“It’s really chilling,” said Moore, who analyzed 26 Chantix reactions in a paper published in the September 2010 issue of the Journal of Pharmacotherapy. “This seems to unleash something in people. It can be violence to anything around.”

Moore’s case studies describe “inexplicable and unprovoked” reactions in Chantix patients with no previous history of violence or mental illness, including:

A 24-year-old woman who started beating her boyfriend in bed because “he looked so peaceful” and later attempted suicide;
A 42-year-old man who punched a stranger at a bowling alley;
A 47-year-old woman who died after she came out of a room, yelled at her daughters and then shot herself.

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J&J, Hip Makers Asked by FDA for Data on Metal in Patients

admin » 12 May 2011 » In Defective Products, FDA, Mass Tort, Recall » No Comments

J&J, Hip Makers Asked by FDA for Data on Metal in Patients

The U.S. Food and Drug Administration asked Johnson & Johnson, which is already facing more than 1,000 lawsuits over hip replacements, to study whether its implants raise the level of metal in patients’ blood to dangerous levels.

The FDA on May 6 sent the request to J&J and 20 other device makers, including Biomet Inc., Stryker Corp. and Zimmer Holdings Inc., asking them to study the levels of cobalt and chromium in patients for at least eight years after implantation. The request focuses on all-metal devices whose failure rates have prompted recalls and increased scrutiny from regulators.

The agency “is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems,” Karen Riley, an FDA spokeswoman, said in an e-mail to Bloomberg News. “There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”

The request comes nine months after DePuy Orthopaedics, a unit of New Brunswick, New Jersey-based J&J, recalled a hip- replacement system that had been implanted in 93,000 patients worldwide. DePuy cited unpublished data from the U.K. national joint registry that indicated a failure rate of 12 percent within five years of implantation.

DePuy “is seeking further clarification from the FDA and considering how to best meet the agency’s requirements,” Lorie Gawreluk, a spokeswoman, said in an e-mail.

Scope of Request

Garry Clark, a spokesman for Warsaw, Indiana-based Zimmer, said in an e-mail that his company was “working to understand the scope of the agency’s request.”

Stryker doesn’t make metal-on-metal implants, Russell Weigandt, a spokesman for the Kalamazoo, Michigan-based company, said in an e-mail. He declined to comment further.

The leading hip makers behind J&J are Zimmer and Stryker, according to a BMO Capital Markets report in February that said the worldwide hip replacement market would grow 3.2 percent this year from $5.28 billion in 2010.

J&J rose 81 cents, or 1.2 percent, to $66.57 at 4 p.m. in New York Stock Exchange composite trading. Zimmer fell 54 cents to $69.15 and Stryker rose 84 cents, or 1.4 percent, to $61.84.

The American Academy of Orthopaedic Surgeons and the leading makers of hip and knee implants last year started a pilot program designed to duplicate joint registries that track patients’ health in the U.K., Australia and other countries.

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