WHAT YOU NEED TO KNOW:
- The Food and Drug Administration (FDA) requested five drug companies to recall their metformin, a diabetes drug, in the market after discovering that it contains cancer-causing contaminants.
- The FDA said that diabetic patients could continue taking metformin drugs to avoid withdrawal risks until doctors could prescribe a new drug.
- The agency is being criticized by government inspectors on its lapses in checking overseas manufacturing plants as pharmaceutical supply chains outside the US grow rapidly.
Five drug manufacturers were flagged by US health regulators over their widely used medicine for diabetes after elevated levels of a contaminant linked to cancer were found in laboratory tests. The medicine was recommended to be pulled out of the market.
The Food and Drug Administration (FDA) said on Thursday that several batches of the metformin drug tested positive for hazardous amount of N-Nitrosodimethylamine — a probable human carcinogen, linked to cancer, that could form during manufacturing processes.
Since last year, the agency had beefed up its research after the chemical was found in dozens of import of blood pressure and heartburn medicines that provoked for the recall of Zantac and other popular over-the-counter and prescription drugs.
In a statement released by the FDA, it said that patients can continue consuming the metformin drug to avoid possible withdrawal risks until their doctors recommend a replacement. More than 34 million Americans in the US have diabetes.
It is not clear whether the movement to recall the metformin drug would lead to shortages, but regulators noted that some drug companies still manufacture generic versions of the drugs that are not essentially affected.
Drug company Apotex Corporation had recalled its metformin drug that was distributed in the country earlier this week after contamination was discovered by the FDA.
Apotex released a statement, saying it voluntarily recalled all supplies of the drug “out of an abundance of caution.” The company added that it stopped selling the drug in the country since February 2019, and that only a small portion remains available in the market.
The four other drug companies who have been requested by the FDA to recall their products were not named.
The FDA noted that immediate-release metformin drugs have no contamination issues.
The agency is accountable for ensuring that drugs that are being sold in the US are safe and have passed sanitary conditions required. However, government inspectors have continued blaming the agency for its lapses checking overseas manufacturing plants as the pharmaceutical supply chain grows rapidly across Asia.
The FDA postponed almost all inspections both locally and globally last March due to coronavirus outbreak.