Posts Tagged 'FDA'

Valsartan Contamination and Cancer: What are the Risks?

valsartan recalled over contamination cancer concernsRecent news stories regarding certain heart medications also came with a startling warning: patients taking medications using the ingredient valsartan may have been unknowingly ingesting chemicals that could be carcinogenic. The issue stems from contamination of valsartan batches with chemicals that are generally used in a wide variety of industrial applications from making rocket fuel to processing fish.

The chemical at the center of the story, NDMA or N-nitrosodimethylamine, was discovered ...

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FDA Sends Mixed Signals on Breast Implants

FDA questions breast implant safety reportThe Food and Drug Administration has agreed to hold a public meeting on breast implant safety while simultaneously saying that it does not agree with claims that the implants may be dangerous.

Led by Dr. Mark Clemens, researchers at the MD Anderson Cancer Center at the University of Texas had previously focused on the risks of an exceedingly rare kind of cancer of the immune system known as continue reading...

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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As FDA Rails Against ‘Vaginal Rejuvenation’ Doctors Say Not So Fast

The FDA has recently taken aim at several companies it says are marketing devices for uses other than those they were approved to treat. At issue is the use of energy and laser devices – usually used in dermatological and other similar procedures – for a treatment that has become known as “vaginal rejuvenation.” The procedure has been said to be capable of remedying several symptoms like vaginal dryness, pain during sex, and other types of ...

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Federal Essure Lawsuits Headed Back to Philadelphia Court

essure lawsuit goes back to state courtEssure will no longer be marketed in the United States in the near future – or anywhere else in the world for that matter – but that doesn’t mean that the lawsuits surrounding the device are going anywhere. And, in at least one situation, a federal court has ruled that, at least for now, it’s not a federal issue.

Bayer had initially requested the move to the federal bench under the ...

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60 Minutes Airs Damning Evidence Against Boston Scientific in Piece on Mesh Claims

60 Minutes airs damaging report on Boston ScienticWith over 100,000 pelvic and other gynecological mesh cases pending in courts around the country, one question that has been on everyone’s mind is much closer to an answer thanks to some investigative reporting that aired earlier this month on CBS’ 60 Minutes.

The question is a simple, yet far-reaching one: what could possibly have gone so wrong with these devices as to cause this level of ...

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