Tuesday, March 16, 2010
$70 million in drugs stolen from Eli Lily warehouse - latimes.com
"Sophisticated thieves in Connecticut scaled the walls, cut a hole, rappelled down and took enough pallets of Prozac, Cymbalta and Zyprexa to fill a large trailer, officials say." [LA Times]
Monday, March 08, 2010
Baxter: FDA Classifies Dialysis Machines Recall As Class I - WSJ.com
Baxter: FDA Classifies Dialysis Machines Recall As Class I - WSJ.com: "Baxter International Inc. (BAX) said the Food and Drug Administration classified a recall of its dialysis machines as a Class I recall, its most severe safety warning.
A Class I recall means there is potential for serious injury or death. Baxter said over the last two years, it has received serious injury reports and at least one patient death report associated with this issue.
The company said it is continuing to investigate the issues surrounding the recall of the dialysis machines, which are used to treat patients with severe chronic kidney failure. Baxter is looking to address issues involving prescription and patient errors." [WSJ]
A Class I recall means there is potential for serious injury or death. Baxter said over the last two years, it has received serious injury reports and at least one patient death report associated with this issue.
The company said it is continuing to investigate the issues surrounding the recall of the dialysis machines, which are used to treat patients with severe chronic kidney failure. Baxter is looking to address issues involving prescription and patient errors." [WSJ]
Thomas Medical Products Issues Class I Recall - A defect in the company's Transseptal Sheath Introducer Kit may lead to serious complications - ModernMedicine
Thomas Medical Products Issues Class I Recall - A defect in the company's Transseptal Sheath Introducer Kit may lead to serious complications - ModernMedicine: "On March 5, the U.S. Food and Drug Administration and Thomas Medical Products Inc. (TMP) announced a Class I recall of the Transseptal Sheath Introducer Kit (other trade names include HeartSpan, CHANNEL FX, Torflex, and Braided Guiding Introducer Kit), as the sheath tip may break off and separate during heart procedures and lead to a blockage that may cause permanent injury such as a stroke, heart attack or death." [Modern Medicine]
Friday, March 05, 2010
Did Depakote Play a Role in Child’s Death?
Depakote - Depakote side effects: "Quincy, MA: The state medical examiner in Massachusetts has ruled that a four-year-old girl’s death at her family home was the result of a drug overdose. Rebecca Riley, who died on December 13, 2006, was prescribed clonidine—a high blood pressure medication that can be used as a sedative in children—for ADHD, and Depakote for bipolar disorder. Carolyn Riley, the girl's mother, was charged with murder in February 2007."
Friday, February 19, 2010
Teva Announces Settlement in Principle regarding Certain Drug Pricing Lawsuits
Teva Announces Settlement in Principle regarding Certain Drug Pricing Lawsuits - MarketWatch: "Teva Pharmaceutical Industries Ltd. /quotes/comstock/15*!teva/quotes/nls/teva (TEVA 58.90, 0.16, 0.27%) announced today that several of its subsidiaries in the United States reached a settlement in principle to resolve claims brought by Ven-A-Care of the Florida Keys, Inc. on behalf of the United States, Texas, Florida, and California under federal and state False Claims Acts." [MarketWatch]
Merck Settles Some Vioxx Suits
Merck Settles Some Vioxx Suits - WSJ.com: "Merck & Co. agreed to pay up to $12.15 million in legal fees and bolster its monitoring of drug safety to settle shareholder lawsuits stemming from the withdrawal of former pain drug Vioxx from the market.
The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx. To help improve safety efforts, the company had already fulfilled one of the terms of the settlement by installing Chief Medical Officer Michael Rosenblatt in December." [WSJ]
The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx. To help improve safety efforts, the company had already fulfilled one of the terms of the settlement by installing Chief Medical Officer Michael Rosenblatt in December." [WSJ]
Corporate Watch
Corporate Watch - WSJ.com: "The U.S. Food and Drug Administration said it plans to implement new 'safety controls' for a class of long-acting asthma drugs, largely by adding tougher warnings about the proper use of the drugs to the product labels.
The changes affect GlaxoSmithKline PLC's Advair and Serevent, Novartis AG's Foradil, which is marketed in the U.S. by Merck & Co. and AstraZeneca PLC's Symbicort. The FDA said the drugs should only be used for the shortest time possible 'to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved.' Patients should then be maintained on another asthma controller medication, the FDA said." [WSJ]
The changes affect GlaxoSmithKline PLC's Advair and Serevent, Novartis AG's Foradil, which is marketed in the U.S. by Merck & Co. and AstraZeneca PLC's Symbicort. The FDA said the drugs should only be used for the shortest time possible 'to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved.' Patients should then be maintained on another asthma controller medication, the FDA said." [WSJ]
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