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European Agency Investigating Testosterone Therapy Link to Cardiovascular Risk

The European Medicines Agency (EMA) is following the footsteps us the U.S. Food and Drug Administration (FDA) and launching an investigation into testosterone therapies to find out what potential cardiovascular side effects they may cause.

The EMA’s decision to act is based on the same pair of studies the FDA cited when it opened an investigation in February. A November study that appeared in the Journal of American Medical Association found a greater risk of cardiovascular injury and death in Veterans Affairs population, according to MedPageToday. A January study in Plus One also found that men 65-years and older were at an increased risk of cardiovascular issues when on the testosterone drugs.

More European Agency Investigating Testosterone Therapy Link to Cardiovascular Risk

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products and conclude whether the marketing for the medications should be maintained, altered, suspended, or withdrawn, Bloomberg.com reported.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

Use of NSAIDs Linked to Atrial Fibrillation

Older people who use common prescription painkillers, including prescription-strength ibuprofen, may be at an increased risk of developing atrial fibrillation, or an irregular heartbeat, according to a new study.

Atrial fibrillation has been known to increase the risk of stroke and heart failure and can lead to death, Health Day News reported. The latest study joins a host of others to link these painkillers – called nonsteroidal anti-inflammatory drugs, or NSAIDs – to a risk of heart attack and stroke. More Use of NSAIDs Linked to Atrial Fibrillation

Jury Finds Takeda and Eli Lilly Guilty in Actos Trial

A federal jury found Takeda Pharmaceutical Co. and Eli Lilly & Co. guilty of hiding cancer risks associated with their diabetes drug Actos and ordered the companies to pay a combined $9 billion in punitive damages in the first U.S. trial of its kind.

The verdict came down Monday. Takeda took the brunt of the punishment, getting hit with a $6 billion charge. Eli Lilly was ordered to pay $3 billion. The judge earlier awarded $1.5 million in compensatory damages to Terrence Allen, who blamed the drug for his cancer. The $9 billion verdict is the seventh largest in U.S. history, according to Bloomberg News. More Jury Finds Takeda and Eli Lilly Guilty in Actos Trial

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

Ceftriaxone Linked to Renal Failure in Children

Children who are given therapeutic doses of Ceftriaxone are at an increased risk of experiencing renal stones and pediatric acute renal failure (PARF), a new study found.

Researchers sad recovery is possible with early diagnosis and prompt pharmacological therapy, according to a retrospective study published March 24 in Pediatrics. More Ceftriaxone Linked to Renal Failure in Children

Lawsuit Claims Pradaxa Caused Cerebral Hemorrhage, Death

A woman has filed a lawsuit against Boehringer Ingelheim Pharmaceuticals, alleging her late husband’s renal failure and intracerebral hemorrhage was the result of his use of Pradaxa.

James Standish died on April 10, 2012, after suffering a “bilateral cerebellar and left frontal subarachnoid and intraparenchymal hemorrhage,” according to The Pennsylvania Record. More Lawsuit Claims Pradaxa Caused Cerebral Hemorrhage, Death

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

Roche’s Accutane Caused Woman’s IBD, Jury Rules

A jury found that Hoffman-LaRoche Inc.’s acne drug Accutane was responsible for a woman developing a form of inflammatory bowel disease (IBD). The New-Jersey jury awarded the woman $1.5 million in what represented the plaintiff’s second victory, after her original verdict was overturned on appeal.

Kamie Kendall Rees will receive an award of $1.5 million in compensatory damages plus $88,000 in past medical expenses, Law360.com reported. Kendall Rees alleged that Roche had knowledge that Accutane can cause IBD, but failed to adequately warn her of the drug’s risks.

At the age of 12, Kendall Rees started taking Accutane to fight her severe recalcitrant nodular acne and developed ulcerative colitis at 15, Law360.com reported. The condition worsened with each year until doctors decided it was necessary to remove her colon in 2006. Kendall Rees was 21 at the time of the surgery.

Accutane was approved by the U.S. Food and Drug administration (FDA) in 1982 as a treatment for severe acne. However, Roche removed from the market in June 2009, acknowledging that the company was taking on increasing costs due to mounting litigation.

Accutane has been named in more than 5,00 lawsuits, citing a series of side effects associated with IBD. Early symptoms of IBD include: severe abdominal pain, sudden weight loss, loss of appetite, pain in joints, rectal bleeding, fever, and skin conditions.

Kendall Rees’ attorney told Law360.com he confident that the verdict will send a strong message to Roche that its failure to warn consumers about Accutane’s risks led to many young people suffering loss of their quality of life.

Lawyers for Roche had argued that Accutane does not cause IBD, insisting that many of the studies linking Accutane to IBD were limited in scope, and yielded results that were arguably more helpful to the plaintiff. However, the jury dismissed that notion. Kendall Rees’ lawyer told Law360 that even with their limitations, the studies were supportive to claims that Accutane can cause IBD.

Rees’ defense claimed Roche intentionally left out the results of human and animal studies conducted on Accutane and but “slow-peddled” reports in an effort to avoid taking the drug off the market, Law360.com reported.