FDA

Testosterone Products: Drug Safety Communication – FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change

Here is the latest alert from the FDA, below. My law partner Roger Orlando (roger(at)orlandofirm.com) is a leader in this litigation, where many men claim lifelong injuries from these products: AUDIENCE: Health Professional, Endocrinology, Urology, Family Practice, Patient ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who …

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Takeda to Pay $2.3 million to Actos Bladder Cancer Victim

Chris Welsh, Esq. www.welsh-law.com A Philadelphia state court jury has ordered Takeda Pharmaceutical Co. to pay more than $2.3 million in damages to a plaintiff suffering bladder cancer. The plaintiff is the fifth Actos victim to be awarded damages by a jury. Jury members found that Japan-based Takeda failed to adequately warn the plaintiff’s doctors about the drug Actos’s cancer risks. Actos, also known as Pioglitazone,  is a drug used to treat adults with type 2 diabetes and poses risk of heart failure, heart attack, and bladder cancer. Despite thousands of lawsuits, the FDA has yet to recall the drug …

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Xarelto News for February 16, 2015

More information about Xarelto litigation across the USA: Bayer Healthcare Pharma began selling the drug in the United States in 2011 after conducting a series of clinical trials. During the trial, some are now claiming that the product maker learned that bleeding from certain sites within the body increased in people taking the medication. One lawsuit claims that “Bayer  used the results of the Rocket AF study, the Record studies, and the Einstein studies to promote Xarelto in their promotional materials, including the Xarelto website, which tout the positive results of those studies,” the complaint says. “However, defendants’ promotional materials …

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Walgreens, Walmart, GNC and Target Pull Dietary Supplements from Shelves

After a threat of legal action from the attorney general, four retailers agreed to remove certain  products from New York shelves. A spokeswoman for New York’s attorney general, Eric T. Schneiderman, declined to comment on the subpoenas. But a law enforcement official with knowledge of the investigation, who was not authorized to discuss the case, said the subpoenas demanded that the four retailers provide evidence of how they would prove the authenticity of their product claims. Ginkgo biloba supplements sold at Target, for example, carried a claim that the products supported “concentration, memory and peripheral circulation, enhancing blood flow to …

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GNC, Target, Wal-Mart, Walgreens accused of selling adulterated ‘herbals’

New York State Attorney General Eric T. Schneiderman and Executive Deputy Attorney General Martin J. Mack issued cease-and-desist orders to GNC Holdings, Inc., Target Corporation, Walgreens, Wal-Mart Stores, Inc., regarding the marketing of up to seven herbal supplements: Gingko  biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, Saw Palmetto, and Valerian root. (Valerian was only tested from Target, in place of Ginseng.)   Here is the letter:  http://www.documentcloud.org/documents/1532311-supplements.html#document/p1    

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