Product News and Recalls

New Impurity Discovered in Heart Medication

Several medications containing valsartan, a component of generic medications used to treat high blood pressure and heart failure, were found to be tainted with a chemical impurity earlier this summer. The discovery of NDMA in the drug, a chemical used in everything from rocket fuel to fish processing, led to a voluntary recall of several valsartan-based medications in July.

NDMA, or N-nitrosodimethylamine, is listed as a possible human carcinogen with the EPA. And while not all valsartan-based medications ...

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Diabetes Drug Linked to Flesh-Eating Genital Infection

sglt2 inhibitors linked to flesh-eating genital infectionDiabetic patients taking Invokana, Farxiga, or Jardiance are on alert over reports that these SGLT2 inhibitors could possibly cause a potentially lethal flesh-eating infection of the genitals. Bloomberg recently reported that SGLT2 inhibitor-induced Fourneir’s gangrene was observed in a dozen patients between March 2013 and May 2018. All cases required surgery and in one case the condition proved fatal. The FDA has said that more cases could ...

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Families Still Reeling in Aftermath of Contamination Findings Seen by Trump Administration as “PR Nightmare”

families suffering as administration treats contamination as a pr nightmare“I know that you can’t bring back three people that I lost, but they’re gone.” This is what retired airman Henry Betz had to say to federal officials during a recent “community engagement session.” The meetings; this one taking place in Horsham, Pennsylvania, are in response to recent revelations that groundwater used by military bases and their surrounding communities throughout the country was contaminated ...

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Monsanto Roundup Cases Highlight Importance of Humanizing Damage

jury finds roundup responsible for man's cancerTwo legal teams assemble in a San Francisco courtroom to argue whether the most popular weed killer in the world caused a school system groundskeeper to develop a terminal instance of non-Hodgkin’s lymphoma. The jury hears the science behind the claims and the challenges to those scientific findings. They get a glimpse into the inner workings of one of the most secretive corporations on the planet. And they meet the ...

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Think the FDA Has Your Best Interests in Mind? You May Want to Think Again.

FDA under fire for industry-friendly approach“Instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.” This is the assessment of Dr. Michael Carome, director of health research for Public Citizen, on the current state of affairs at the Food and Drug Administration.

Earlier this summer, ProPublica published a damning look at the agency responsible ...

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Medical Community Turns Against Textured Breast Implants

warnings increase on textured breast implantsWhat a difference seven years can make.

The FDA first mentioned a possible link between rough-textured breast implants and a particular type of lymphoma in 2011. The warning was more of a glancing blow than anything and failed to raise any significant alarms – after all, the risk of breast implant-associated anaplastic large-cell lymphoma was purported to be less than one in 500,000. As one implant manufacturer chided, “A woman is more ...

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