According to a story from The People’s Pharmacy, the US Food and Drug Administration (FDA) has given the green light for the use of generic drugs manufactured in India despite the fact that there have been safety problems with them. 2019 was a year filled with several drug recalls as a result of safety and quality concerns. A number of recalls involving India-made pills have cropped up lately, but the agency hasn’t indicated any inclination to slow down the importation of generics from the country.
Contaminated Meds
The first case that gained significant attention involved generic versions of blood pressure pills called angiotensin receptor blockers (ARBs). Two different ARBs, valsartan and losartan, were found to be unusable because they were contaminated with chemicals called nitrosamines, which have been linked to cancer. A massive recall of these drugs had to be implemented. Since then, the drug ranitidine, which is widely used to suppress acid, also had to be recalled because of nitrosamines. Another potential problem medication has also been identified: metformin, which is used to treat diabetes.
No Signs of Slowing Down
Despite the clear pattern of contamination and safety issues, the use of Indian generics has only increased, with 43 percent of all generic approvals coming from India this year. The FDA has issued an unprecedented number of warning letters to the drug manufacturers linked to contaminations. As for metformin, Singapore has already recalled three versions of the drug because of excess nitrosamines. Valisure, a testing lab and pharmacy based out of New Haven, CT, says that 60 percent of metformin batches it has evaluated have failed tests for nitrosamine.
Before an official recall is issued, the FDA has gotten into the habit of issuing statements that encourage patients to continue to use medications as prescribed while the agency conducts additional testing…only for a contamination problem to ultimately reveal itself. Sometimes the recalls aren’t announced for months, giving patients plenty of time to absorb levels of nitrosamines or other contaminants that are considered harmful. This has been standard practice for years.
This rather lackadaisical approach to safety can hardly be reassuring to patients. While generic drugs can be very useful and concerns about drug shortages also need to be accounted for, the FDA should be taking stronger action to make sure that these drugs are safe before US citizens start using them.
