ICYMI: Drug Shortages Lead to Approval of Questionable Generics from Overseas by FDA

By Caitlin Seida from In The Cloud Copy

2019 was a record year for drug recalls due to safety and quality concerns. It’s also been a record year for the U.S. FDA to issue warning letters to overseas manufacturers of generic drugs based on quality, efficacy, and contamination issues. Notably, drugs from India have increased to represent 43 percent of all generic approvals on the American market – leading to concern among many.

Drug Shortages and Record Approvals

Hospital drug shortages are the driving force behind the FDA’s decision to allow generic imports of drugs from India. In 2018, 36 percent of all generic drug approvals came from India. In 2017, a mere 27 percent of the market was imported from the country. With shortages already hitting “critical levels,” further restriction of generic imports from India could spell catastrophe for patients who require medication for survival.

FDA Warnings

Among international manufacturers cited for lack of quality controls and contamination were some of India’s biggest companies, including Torrent and Glenmark Pharmaceuticals, and respectively, Lupin, Aurobindo, and Cadila.

Concerns over biological contamination present during manufacture, shady recordkeeping practices surrounding quality control, and other red flags were the reasons for the distribution of letters.

Contamination Concerns

The most recent contamination scare surrounds the diabetes drug metformin, which many patients rely on to increase insulin sensitivity and control high blood glucose levels. Up to 60 percent of generic batches tested were found to contain N-Nitrosodimethylamine, or NDMA.

This chemical is a nitrosamine, a compound formed when nitrites and amines merge due to an acidic environment. Occurring naturally in low levels in food, water and even the human body, the levels found in these generic drugs are considered hazardous: nitrosamines are genotoxic, causing cell mutations to occur, and are potential carcinogens.

The metformin scare has come on the heels of other drug concerns, including ranitidine/Zantac, which treats heartburn, and several Angiotensin II receptor blockers like Valsartin and Losartin, which are commonly used to lower high blood pressure, treat diabetic neuropathy, and are part of treatment plans for congestive heart failure. Ranitidine and several angiotensin II receptor blockers have been recalled by the FDA over high levels of NDMA in the past year and a half, with no current recall of metformin underway or planned.

“Keep Taking Your Metformin”

Dr. Janet Woodcock, the director of the FDA’s own Center for Drug Evaluation and Research, urged patients to continue taking metformin while the agency investigates potential contamination concerns in an official statement issued on December 5, 2019. The statement went on to mention that, although regulatory agencies outside the US have recalled the drug, there are no plans at this time to do so within the United States. If high levels are found, the agency plans to recommend recalls if the levels present are “above the acceptable daily intake limit of 96 nanograms.”

The official statement rings hollow for many, who are concerned about possibly not finding out about carcinogen exposure until long after the fact, when the damage is already done. Patients concerned about their medications can opt to have them tested for impurities at great cost by an independent lab or ask their healthcare providers to require brand name drugs as a medical necessity on their prescriptions – again, probably incurring greater costs.

Check out the source article here.


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