Chemotherapy drugs contaminated: Manufacturers ignored over 200 bad quality tests, U.S. FDA says
(NaturalHealth365) No one would argue that chemotherapy cancer drugs are toxic to the human body. Choosing to get this form of treatment is a deeply person decision. But, when warnings are issued and ignored – due to contamination concerns – by the pharmaceutical industry, that’s criminal and must not be tolerated! (no matter how you feel about conventional cancer treatments)
Caner patients need to know: chemotherapy does as much damage to healthy cells and tissues as they do to cancer cells. These drugs have horrific side effects and cause many health problems, even in those who survive cancer – due to its harm on the immune system.
Safety checks halted on chemotherapy cancer drugs when contaminants were detected
This seems to be the case with a company called Fresenius, although it’s uncertain what quantity of tainted drug components have made it to market. Also, the U.S. Food and Drug Administration (FDA) “strikes again” by delivering barely a slap on the wrist to the Fresenius company for these lapses in quality.
Fresenius is a major healthcare provider in Europe. The company has 25 drug manufacturing facilities worldwide, and their plant in India creates components for cancer drugs.
Recently, plant workers found potentially tainted products among recent manufactured chemotherapy drug ingredients. In response, the plant immediately halted testing and threw out the results, saying machine and human errors were to blame.
This information was made public in a Dec. 4, 2017 FDA letter citing 248 aborted safety checks at the facility located in West Bengal.
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U.S. FDA not tough enough on the manufacturers of chemotherapy cancer drugs
The recent FDA letter asked for an “immediate comprehensive assessment” of the company’s manufacturing operations and processes. The FDA used firm language in its letter to Fresenius and recommended that they “hire a consultant” to assist them in improving manufacturing processes and practices.
However, we’re left wondering if this is enough to ensure the safety of consumers who might one day be given chemotherapy drugs made with potentially tainted ingredients?
The parent company, which is based in Bad Homburg, Germany, did not issue any response to requests for comments on this serious matter. Also, the names of the specific ingredients suspected of being tainted were redacted in the publicly released version of the FDA letter.
Documents gleaned from drug master files from the Fresenius company’s past dealings with the FDA verify that they are known for manufacturing many of the components of chemotherapy cancer drugs.
Another reason to seek safer, more effective alternatives to chemotherapy
Fresenius was asked to review all failed quality tests and instances where tests were aborted to determine the potential effect on quality and efficacy. The FDA also warned that it “may” refuse admission of its products into the U.S. – if the company does not take these steps.
Again, this seems like a very mild response to such a potentially serious matter. Fresenius should be called out by the FDA to show ironclad evidence that its chemotherapy cancer drug components are safe.
Chemotherapy drugs are harmful enough to the human body. The FDA should be doing more to protect us from companies that might be making these toxic cancer drugs even worse.
Sources for this article include:
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