A new report out of the Milwaukee Journal Sentinel calls attention to the fact that the FDA’s tracking of drug side effects; many of them dangerous, has been out of date, underreported, and inaccurate for upward of 60 years.
Created in 1960, the system was devised as a way of tracking adverse drug events once the products received their clearance and made it to market. Based ...
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“The Stamford, Connecticut-based company wants to convert into a public benefit corporation that would no longer be owned by members of the Sackler family. The plan calls for the new company to continue making OxyContin, but with the profits going toward fighting the opioid crisis, which has been linked to 470,000 deaths in the U.S. since 2000.”
Whether a more cognitively dissonant combination of words has ever been assembled in ...
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Diabetics who take metformin will want to contact their healthcare providers after multiple recalls of the drug have occurred due to the discovery of elevated levels of a cancer-causing compound. Multiple lots of the extended release version of the drug from multiple manufacturers tested positive for the presence of NDMA, or N-Nitrosodimethylamine, in amounts that exceed FDA regulations.
According to the FDA, humans should be able to tolerate ...
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A recall has been issued for the Medtronic Rashkind balloon septostomy catheter. 142 of the devices are covered under the federal recall action and were distributed throughout the United States between May 2018 and August 2020.
According to the FDA, the recall was issued because “quality issues…may lead to the device breaking, separating or failing during use.” The agency goes on to say that “if this occurs, ...
continue reading...In the first three years of the Trump administration, a grand total of 12 letters were sent by the FDA to drug makers warning them over violations found in their clinical drug trials. The agency’s warning letters are sent when the FDA notes violations of practice, procedure, or in some cases, law. In contrast, the first three years of the Obama presidency saw 99 such letters ...
When the FDA made the decision to give Johnson & Johnson’s diabetes drug Invokana a black box warning in 2017, one would like to believe that the decision was not made lightly. The boxed warning is the strongest warning the agency can issue for a drug on the US healthcare market and indicates that the product can pose grave risks to the consumer if used. There is ...
