BREAKING!! Metformin: US FDA Issues Warning That Carcinogenic Contaminants Found In Several Brands Of The Diabetes Drug And Starts Recall
Source: Metformin and Diabetes May 30, 2020 4 years, 5 months, 3 weeks, 4 days, 14 minutes ago
Metformin: The US FDA has issued warnings that many brands and versions of the drug Metformin that is used by diabetics in the US and around the world have been found to be contaminated with a carcinogenic compound called N-Nitrosodimethylamine.
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The U.S. health regulators have started telling five drugmakers to recall their versions of a widely used diabetes medication after laboratory tests found elevated levels of a contaminant linked to cancer.
There are more brand being identified not just these five and the situation is said to be worse in Asia according to sources. They said that brands made in India, Indonesia, Philippines, Vietnam and China were found to be even more worse off as the concentration of these carcinogenic contaminants were found to be higher.
One of the safest versions of Metformin was said to be that produced by the Government Pharmaceutical Organisation (GPO) in Thailand and it is extremely cheap yet made to the highest manufacturing standards. The Thailand GPO is famous for making lots of generic drugs that are inexpensive but of extremely superior quality.
The US Food and Drug Administration said late Thursday that several batches of the drug metformin tested positive for unsafe levels of N-Nitrosodimethylamine, a possible cancer-causing chemical that can form as a manufacturing byproduct.
The FDA has stepped up testing after the chemical was found in dozens of shipments of blood pressure and heartburn drugs last year, triggering recalls of Zantac and other popular over-the-counter and prescription medications.
Unfortunately many people could be affected as metformin tablets are a staple of diabetes care, reducing excess sugar in the blood. People with Type 2 diabetes use metformin alone or with other drugs to help control their blood sugar levels. More than 36 million people in the U.S. have this disease.
It is recommended that patients should continue taking metformin drugs until their doctor can prescribe a replacement, the FDA said in a statement, noting the risks of discontinuing.
American regulators are still assessing whether the recalls will lead to shortages of metformin, but noted that a number of other companies make generic versions of the drugs that don't appear to be affected by the issue especially those made in Thailand.
Canadian drugmaker Apotex Corp. recalled its extended-release metformin distributed in the United States and elsewhere earlier this week after the FDA found contamination in one lot. Apotex said in a statement it voluntarily recalled all supplies of the drug "out of an abundance of caution." The company said it stopped selling the drug in the U.S. in February 2019 and that little remains on the market.
The US FDA announcement did not name the four other drugmakers who have been requested to recall their products and there are also others on the list that has yet to be informed.
The US agency noted that no contamination problems have been found in immediate-release metformin.
The US FDA is responsible for en
suring that medicines for the U.S. market are made in safe, sanitary conditions that meet federal quality standards. But government inspectors have repeatedly criticized the agency for falling short in reviewing overseas manufacturing plants as the pharmaceutical supply chain has increasingly spread to Asia.
Unfortunately, in March and April, the US FDA suspended nearly all U.S. and foreign inspections due to safety concerns and travel restrictions caused by the COVID-19 outbreak.
However it has since resumed all operations and inspections since beginning of May.
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