Posts Tagged 'Food and Drug Administration'

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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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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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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In the Absence of Safety Warnings, Actemra May Have Killed Hundreds

rheumatoid arthritis drug actemra may be responsible for hundreds of deathsAs horrible as it can be to endure a life with rheumatoid arthritis, the side effects of the drugs most commonly associated with the treatment of the condition are equally, if not more terrible. In an analysis of more than half a million side effect reports from these medications, clear patterns emerged that indicate strong links to heart attacks, strokes, and heart failure.

Actemra was marketed with ...

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FDA Issues Safety Announcement for New Liver Disease Drug

fda issues statement on OcalivaBloomberg reports that the FDA has issued a safety announcement for Intercept’s Ocaliva, a drug designed for a rare liver disease known as primary biliary cholangitis. The announcement comes after at least 19 deaths were attributed to the medication, which was only introduced in May of 2016.

Intercept claims to have explicitly warned doctors of the specificity with which they must prescribe Ocaliva and how it must be taken by patients. ...

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Opana ER Pulled from Shelves Over Abuse Concerns

sales of opana halted by FDAEndo Pharmaceuticals has officially withdrawn Opana ER from the market at the FDA’s request. The extended release opioid medication recently became the subject of an inquiry by the agency because of the specific way it was being abused.

Opana ER was designed to slowly and steadily medicate a patient as an extended release medication. However, when crushed, snorted, or injected, an abuser can get the full dose in a ...

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