February, 2009FDA Gives Limited Approval to Implanted Brain Stimulator for Treatment of Severe OCD
The U.S. Food and Drug Administration has given limited approval to an implantable deep brain stimulator, made by Medtronic Inc., for the treatment of severe obsessive-compulsive disorder. The Reclaim DBS Therapy device, already approved for help treating tremors associated with Parkinson’s disease, is not FDA-approved for treatment of obsessive-compulsive disorder (OCD). The anxiety disorder commonly forces people in response to stress to perform repeated actions, such as frequent hand washing, cleaning, counting, or similar actions. Humanitarian Exemption Granted Under an …
Continue →Zonisamide (marketed as Zonegran, and generics)
Audience: Neurological healthcare professionals [Posted 02/23/2009] FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures…
Have Yankees Damon and Nady Struck Out as Stanford Investors? Major Leaguers Among Those With Frozen Assets
New York Yankees outfielders Johnny Damon and Xavier Nady are among those whose bank accounts and other financial assets have been frozen amid the continuing investigation into the dealings of tycoon banker R. Allen Stanford.
Continue →Salmonella Outbreak Reaches the Courts; Dozens of Lawsuits, Bankruptcy Liquidation to Follow
The nationwide outbreak of deadly salmonella-contaminated peanut products blamed for nine deaths, more than 600 illnesses, and one of the largest food recalls in U.S. history has now spread to the courtroom.
Continue →More Information Sought on Cholesterol Drug Vytorin
Members of a Congressional panel investigating the cholesterol-fighting drug Vytorin want more information about clinical trials of the drug, which has been linked to an increased risk of heart attacks and strokes. Vytorin, marketed by Merck and Co. and Schering-Plough Corp., is a cocktail containing the drugs Zetia and Zocor. However, some studies have found the drug can lead to heart-related deaths. This week, Congressman Henry Waxman (D-Cal.), who is chairman of the Energy and Commerce Committee, sent a letter …
Continue →How Did the SEC Miss the Red Flags on Stanford, Madoff? And How Many More Billion-Dollar Scams Are Out There?
For years, red flags had been popping up in the financial empire of flamboyant Texas billionaire banker R. Allen Stanford. Financial advisers were selling clients on millions of dollars in complicated investments neither fully understood and a tiny accounting firm in Antigua few had even heard of was the billion-dollar company’s accountant.
Continue →Fallen Money Manager Madoff Never Purchased Securities for Clients, Investigator Says
The man charged with unraveling the massive financial scam allegedly carried out by New York City financial adviser Bernard Madoff said he can find no evidence to show that that the fallen money manager ever purchased securities for his clients, as promised.
Continue →New Laws to Reinstate Suits for Injuries Caused by Defective Medical Devices Expected Soon
Federal legislation designed to nullify a controversial U.S. Supreme Court decision granting companies that make heart defibrillators, stints, and other approved medical devices total immunity from state personal injury liability lawsuits is expected to be introduced soon, national leaders said.
Continue →Stryker Employees Admit Wrongdoing in Marketing of Human Bone Growth Products
Two former sales associates for medical-device maker Stryker Corp. have pleaded guilty to charges they falsified company documents and promoted unapproved, off-label uses of company products they knew had caused earlier problems in patients.
Continue →FDA Issues New Health Advisory For Psoriasis Drug Raptiva
The Food and Drug Administration has just issued a health advisory in response to reports of deadly brain infections in people who use the psoriasis drug Raptiva. There have been three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in people taking Raptiva. Of those four people, three are now dead. All patients has been treated with Raptiva for at least three years.
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