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FDA Panel Backs New Testosterone Drug Safety Limits

Amid concerns over testosterone therapy side effects, an FDA panel has backed limitations on labeling for testosterone to exclude prescriptions for men who take the therapy only to counteract ordinary signs of aging rather than specific hormonal abnormalities. The panel also voted overwhelmingly to require clinical safety trials for some... Read more »

Monitoring, Dosing Adjustments could Minimize Pradaxa Bleeding Events, Investigation Finds

An investigation by Deborah Cohen of the British Medical Journal (BMJ) has revealed that Pradaxa manufacturer Boehringer Ingelheim may have withheld analyses that might have prevented some Pradaxa bleeding events. Monitoring and dosing adjustments could make use of the drug even safer and more effective, according to Cohen’s findings. However, the... Read more »

Blue Cross Blue Shield Sues Takeda, Actos Manufacturer

Blue Cross/ Blue Shield of Massachusetts has taken legal action against pharmaceutical giant Takeda, claiming the company failed to warn consumers and the medical community about the association between Actos and bladder cancer. The healthcare provider is now seeking compensation for costs of bladder cancer treatment for hundreds of their... Read more »

Testosterone Therapy Lawsuits Centralized

All testosterone therapy lawsuits filed in U.S. District Courts nationwide, alleging injuries because of Low T treatments, will now go before one judge in the Northern District of Illinois in centralized litigation known as “multidistrict litigation” or MDL. This move comes on the heels of June 6 order by a... Read more »

Bacterial Contamination Prompts Expanded Naturalyte Recall

On May 21, 2014, Fresenius Medical Care announced an expanded Naturalyte recall due to bacterial contamination.  The product recall was first issued in April after Halomonas bacteria was found in several lots of the dialysate additive.  The amended Class I recall now affects 56 lots of Naturalyte. The acid concentrates,... Read more »

Las Vegas Actos Trial Ends in Defense Verdict

On Thursday, May 22, jurors in the Las Vegas Regional Justice Center handed down a defense verdict for Japanese drug maker Takeda, in an Actos trial that has been closely monitored across the nation. The case was brought by two elderly women — Bertha Triana and Delores Cipriano – both... Read more »