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EU Regulators Reviewing Testosterone Medication Heart Risks

The European Medicines Agency is reviewing testosterone medications after studies suggested the drugs may be linked to cardiovascular risks.

The European Union’s (EU) drug regulator will study the benefits and risks of testosterone products and conclude whether the marketing for the medications should be maintained, altered, suspended, or withdrawn, Bloomberg.com reported. More EU Regulators Reviewing Testosterone Medication Heart Risks

Janssen Pharmaceuticals Settles 76 Topamax Birth Defects Cases

Johnson & Johnson (J&J) has settled with 76 plaintiffs who alleged birth defects in the babies of women who took the anti-epilepsy and migraine drug Topamax during their pregnancies.

Judge Arnold New filed an order last Tuesday marking 76 of the cases as discontinued after receiving confirmation that the plaintiffs had reached settlement agreements with J&J’s Janssen Pharmaceuticals unit. Judge New is coordinating a mass tort docket of Topamax cases in the Philadelphia Court of Common Pleas, according to Law360.com. More Janssen Pharmaceuticals Settles 76 Topamax Birth Defects Cases

Testosterone Therapy Allegedly Caused Heart Attack, Testim Lawsuit Filed

A Vineland, New Jersey couple is suing Auxilium Pharmaceuticals Inc. and Philadelphia’s GlaxoSmithKline for an injury the husband alleges was caused by the companies’ testosterone replacement drug, Testim.

According to the complaint filed in Philadelphia’s Common Pleas Court, Edwin Rios believed he was suffering from “Low T,” an alleged condition that causes symptoms such as low sex drive, fatigue, irritability, and loss of muscle mass. The complaint alleges that Auxilium and GlaxoSmithKline knew that a decrease in testosterone levels in men is a normal part of the aging process and that unnaturally restoring testosterone puts men at risk for cardiovascular events, according to PennRecord.com More Testosterone Therapy Allegedly Caused Heart Attack, Testim Lawsuit Filed

Attorney General Sues Makers of Plavix, Alleges Deceptive and Unfair Marketing and Labeling

Hawaii Attorney General (AG) David M. Louie filed a complaint against Bristol-Myers Squibb Co. and Sanofi-Aventis US LLC in state court on Wednesday alleging the drug companies deceptively and unfairly labeled and marketed its blood thinner, Plavix.

According to the complaint, the companies didn’t reveal that Plavix has little or no impact on the 30 percent of the population who metabolize the drug poorly because of their genetic traits or because they take other drugs, Law360.com reported. More Attorney General Sues Makers of Plavix, Alleges Deceptive and Unfair Marketing and Labeling

Takeda CEO Admits Improper Marketing of Blood Pressure Drug

The chief executive of Takeda Pharmaceutical Co. said the company had used “inappropriate expressions” in promoting its blood pressure drug Blopress, but denied claims that the drug maker tampered with any research data.

Takeda CEO Yasuchika Hasegawa made the admission after the Japanese health ministry said last week it was investigating questions raised by a Japanese doctor that a graph used in the company’s advertisement did not match the results of a clinical study, Bloomberg News reported. More Takeda CEO Admits Improper Marketing of Blood Pressure Drug

PA State Judge Orders Creation of Mass Tort for Pelvic Mesh Injury Lawsuits

Pennsylvania State Judge Arnold New ordered the creation of a mass tort last week for product liability lawsuits filed over pelvic mesh products that many patients allege caused them injuries.

Judge New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas ordered February 11 that “all currently filed pelvic mesh matters shall be transferred to the Complex Litigation Center Pelvic Mesh Mass Tort Program” for coordination, according to court documents obtained by MassDevice.com. More PA State Judge Orders Creation of Mass Tort for Pelvic Mesh Injury Lawsuits

West Virginia Residents Worried they are Inhaling Formaldehyde from Chemical Spill

More than three weeks after a chemical spill left 300,000 West Virginia residents without clean running water, there is new health concern: formaldehyde.

In the hours following the discovery of the leak, health officials struggled to provide accurate and reliable information about 4-methylcyclohexanemethanol, or MCHM, which was spilling into the Elk River. Residents were instructed not to cook or drink with their tap water but were told little else. Now it has come to light that MCHM can break down into formaldehyde, and residents are likely inhaling it, according to LATimes.com. More West Virginia Residents Worried they are Inhaling Formaldehyde from Chemical Spill

C.R. Bard Transvaginal Mesh Lawsuits Moving Forward

A federal judge has ordered C.R. Bard and plaintiffs involved in a multidistrict litigation (MDL) against the medical device maker over its Avaulta mesh product to select 200 lawsuits for discovery.

MassDevice.com reported that Bard is facing more than 7,000 product liability lawsuits filed by patients who allege they were injured by the firm’s Avaulta transvaginal mesh. More C.R. Bard Transvaginal Mesh Lawsuits Moving Forward

Class I Status Given to Nephros Water Filter Recall

The U.S. Food and Drug Administration (FDA) has given Class I status to Nephros Inc.’s recall of its In-Line Dual Stage Ultra (DSU) filter.

The recall was initiated because promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. The affected marketing materials include the following document numbers: 60-0237 Nephros Ultrafilters Technical Dossier (Infection Control) and 60-3003 Nephros In-Line DSU Filter Brochure. More Class I Status Given to Nephros Water Filter Recall

FDA Warns Consumers Against Using Mass Destruction Supplement

The U.S. Food and Drug Administration (FDA) is advising consumers to immediately stop using a dietary supplement product called Mass Destruction. The product label indicates that it contains at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.

Mass Destruction is marketed as a dietary supplement that aids in muscle growth. The North Carolina Department of Health and Human Services alerted the FDA of a serious injury associated with use of the supplement and described a previously healthy 28-year-old male who suffered liver failure after using the product for several weeks. The man required a liver transplant. More FDA Warns Consumers Against Using Mass Destruction Supplement