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In
this issue:
Study Links Antipsychotics to Weight Gain
A large-scale study has concluded that children and adolescents taking antipsychotic medications are at risk for rapid weight gain and drastic metabolic changes, the New York Times reports. According to the study, published Wednesday in the Journal of the American Medical Association, patients taking the most popular antipsychotic drugs added 8 to 15 percent to their weight within twelve weeks of beginning the medication. Changes in weight and metabolism could lead to a variety of health problems, researchers warned. Duff Wilson, The New York Times 10/27/2009
Approved Drugs Often Untested, Report Finds
Drug makers failed to complete one-third of required studies after drugs were approved by federal regulators, a report released Monday concluded. The finding from the Government Accountability Office is the latest knock against the enforcement power of federal agencies that oversee drug and medical device makers. Some studies had been pending for five to eight years, the report noted. Gardiner Harris, The New York Times 10/26/2009
Jury Sides with Plaintiff in First Zometa Trial
A Montana jury has ordered Novartis Pharmaceuticals Corp. to pay $3.2 million to a woman who developed degenerative jaw problems after taking the bone-strengthening drug Zometa. In the suit, Peggy L. Stevens claimed that Novartis failed to warn that Zometa could cause osteonecrosis. An attorney for Stevens said he expects the verdict to have a significant effect on consolidated Zometa cases pending in state and federal courts. Tristan Scott, Missoulian 10/22/2009
Report: FDA Allowed Research Despite Fraud
The Food and Drug Administration routinely allowed drug researchers convicted of fraud to continue experiments despite federal law requiring they be banned, a report by federal investigators has concluded. In one case, the Government Accountability Office found that the agency waited four years before initiating a research ban on a woman convicted of falsifying data and patient records during drug studies. In a statement, the FDA said it has since improved its processes to stop those convicted of fraud from participating in drug research. Gardiner Harris, The New York Times 10/21/2009
Botulism Fear Sparks Baby Food Recall
A California company has announced the recall of its baby food products citing fears about botulism poisoning. The recall affects Plum Organics apple- and carrot-flavored baby food with a "best by" date of May 21, 2010. The food is available at Toys R Us and Babies R US stores. Karen Yi, New York Daily News 10/20/2009
Program to Track Lasik Problems
A three-year program plans to track the number of Lasik vision-correction patients who suffer from post-operative problems, according to announcement last week by federal officials. The program plans to assess how many and which patients suffer from lasting problems including painful dry-eye, poorer vision, halos, glare and blindness. The program will be conducted in three stages by the Food and Drug Administration, the Defense Department and the National Eye Institute. Melissa Healy, LA Times 10/19/2009
First Zometa Suit Could Serve as Bellwether
Plaintiffs in more than 500 lawsuits are closely watching a trial in Montana that could serve as a bellwether for a mass tort action over the bone-strengthening medication Zometa, the Missoulian reports. The plaintiff in the Montana case alleges that Novartis Pharmaceuticals Corp. failed to warn that Zometa could cause a degenerative jaw disorder called osteonecrosis. Closing arguments in the Montana case are scheduled to begin Tuesday. Tristan Scott, Missoulian 10/19/2009
Crash Raises Questions about Safety of Toyota Vehicles
A fatal accident earlier this year involving a California Highway
Patrol officer driving a 2009 Lexus ES 350 is raising new questions
about safety problems with vehicles made by Toyota Motor Corp., the Los
Angeles Times reports. Toyota has blamed such incidents on defective
safety mats that can cause accelerators to become stuck. However,
safety experts warn that complex systems in Toyota vehicles may make
difficult for drivers to safely recover from unwanted acceleration.
Ralph Vartabedian, LA Times 10/18/2009
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