FDA Fails Again

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Despite FDA approval, low levels of a probable carcinogen have been found in common heartburn drugs on the shelves sold under the name Zantac. This isn't uncommon, as products that get approved by the FDA have commonly been recalled or known to contribute to a wide variety of ailments and injuries.

Regardless of their efforts to make things safe, they've demonstrated that there will be many shortcomings.

Zantac and its generics allegedly contain small amounts of NDMA and this isn't the first time that this has happened, earlier this year some other medications were also recalled after they were found to contain the same carcinogen.

It's been reported that preliminary testing has found that both generic versions and the brand name product of the heartburn and acid reflux drug contained the NDMA. According to the FDA, they detected levels of NDMA that slightly exceed those which are similarly found in foods such as grilled meats.

So far they haven't recommended that people stop taking the drug.

One U.S. based online pharmacy and lab had tested generic versions and Zantac and found that all versions contained concerning levels of NDMA; higher than the FDA's recommended daily limits. They suggest that the FDA needs to evaluate larger samples to ensure safety. FDA officials say that they don't want people to panic over this revelation, they suggest that for those who have to take these medications that it isn't a high risk situation.

NDMA or N-nitrosodimethylamine is listed as a probable human carcinogen that's believed to potentially cause cancer at high levels.

"contaminants should not be in these drugs. We’re going to make sure they get out." - J. Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Although the FDA has said it isn't a high risk situation and they aren't urging any recall, they have suggested that people now go looking for market alternatives, another suitable over-the-counter drug option, but that move should involve a discussion with their doctor and pharmacist.

The public is only now learning about this information arguably thanks to the work of Valisure and their investigation which discovered the problem. Although, the FDA has allegedly been investigating NDMA in various medications since last year. Valisure, the online pharmacy, has filed a petition with the FDA that requests the removal of the medications in question, along with a suspension of sales.

“Every manufacturer and every type of Zantac or ranitidine that we’ve analyzed seems to have the same problem of the drug itself being very unstable and degrading, or even potentially reacting to, the condition in the human stomach to create NDMA,” - D. Light, CEO of Valisure.

The FDA has already sanctioned one plant located in India, that is said to be involved with the manufacturing of some ingredients that are used in these medications. Overall, the FDA are still currently investigating the issue.

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The information that is posted above is not intended to be used as any substitute for professional medical advice, or diagnosis or treatment. The above is posted for informational purposes only.



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10 comments
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There is a lot of FDA fails again stories these days...

Has there been a FDA success story?

I mean it was started to give confidence back to a group of meat packers that had poisoned their clients... i guess that was a success... :-/

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Pretty good at checking for measly pork in the US at least. Haven't seen pork tapeworms regularly except in some immigrant populations.

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The FDA gets the pork industry to check the pork themselves.

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