The Food and Drug Administration recently notified executives at medical device manufacturer Medtronic that its efforts at rectifying significant issues within its diabetes business are falling short. “In summary,” the agency said, “your corrective actions are still in process, and you have not yet conducted effectiveness checks to ensure the updated procedures and required employee training will prevent reoccurrence of the identified deficiencies.”
The letter comes ...
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The metformin recalls that have plagued the diabetes drug industry for the past year continue as yet another company’s formulation of the drug has tested positive for a human carcinogen.
The debacle started in 2020 when lots of metformin from Teva Pharmaceuticals and Sun Pharmaceuticals both tested positive for NDMA, or N-Nitrosodimethylamine. The compound is believed to have ties to variety of types of cancer and the discovery was enough to trigger recalls ...
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Two lots of diabetes drug metformin produced by Kansas City, Missouri drug maker Nostrum Laboratories are being pulled from pharmacy shelves over concerns that they might be contaminated with a cancer-causing compound. The compound, known as NDMA or nitrosamine, was detected in the company’s 750mg HCI extended-release tablets at levels that exceed federal regulations.
NDMA is a naturally occurring chemical that is found in everything from the fruits ...
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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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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 ...
There is no way to overstate the importance of the discovery of insulin and the impact it has had on the world. Insulin has either extended or saved the lives of countless diabetics in the nearly 100 years since the discovery occurred. While the event and the attention it would bring would lead to significant strains on the interpersonal relationships of those involved, the researchers nonetheless ...
