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FDA Embraces Generic Drugs from India Despite Quality Problems

The nitrosamine controversy continues. Now add the diabetes drug metformin to a list of potential problem pills. How reliable are generic drugs from India?
Metformin pills

2019 has been a year of many drug recalls because of concerns about quality and safety. The FDA announced a number of recalls involving blood pressure pills called ARBs. Angiotensin receptor blockers such as losartan and valsartan were contaminated with nitrosamines, probable cancer-causing chemicals. Then a popular acid-suppressing drug called ranitidine was also recalled because of concerns about nitrosamine formation. Now questions are being raised about some batches of the popular diabetes drug metformin. Despite so many problems with generic drugs from India, the FDA has welcomed a record number of new generic drugs from that country.

Record Warnings and Record Approvals of Generic Drugs from India:

A new report from India suggests that the US Food and Drug Administration has issued a record number of warning letters to Indian pharmaceutical companies.

Himani Chandna has written in the publication ThePrint (Dec. 3, 2019) that:

“American drug regulator FDA has issued warning letters to India’s top firms such as Lupin, Glenmark Pharmaceuticals, Torrent Pharmaceuticals, Aurobindo & Cadila.”

She goes on to write:

Dateline New Delhi: From spotting ‘live moths’ in raw materials to finding ‘bacteria-contaminated water’ in the manufacturing process, to unearthing ‘shredded’ records of quality control, the US Food and Drug Administration (FDA) has found several reasons to slap Indian drug-makers with ‘warning letters’ — a record high number of them — in 2019.

Metformin Under Scrutiny for the Nitrosamine NDMA

The FDA admits that it is testing samples of metformin for the probable carcinogen, N-Nitrosodimethylamine (NDMA). That is the same nitrosamine that was found in ranitidine. As usual, the FDA appears to be behind the eight ball.

According to FiercePharma (Dec. 5, 2019)

“But the ball could already be rolling on metformin after the Singaporean Health Sciences Authority announced Wednesday it had recalled three of 46 versions of the drug sold in the country after finding NDMA above the ‘internationally acceptable amount.”

We also checked with David Light, CEO of Valisure. This pharmacy and testing laboratory in New Haven, CT, tests every batch of medications it sells.

We were told that Valisure has been:

“having problems with metformin as well and have failed 60% of the batches we tested for concern over NDMA.”

Some of those failed products came from Indian generic drug manufacturers.

The FDA’s Official Statement On Metformin and NDMA:

Dr. Janet Woodcock is the Director of FDA’s Center for Drug Evaluation and Research (CDER). She is one of the most important people at the agency.

Last night our inbox had this official statement from the FDA (December 5, 2019):

“The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products…

“The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA. Based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water. While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time. The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found.”

Dr. Woodcock tells patients to keep taking their metformin while the FDA does further testing. That has been the message with almost all the nitrosamine contamination. Don’t worry, be happy! Continue taking your valsartan, losartan, irbesartan, ranitidine, Zantac, etc. The levels of nitrosamines aren’t all that bad. The FDA is on the job protecting you from contaminated chemicals. Then a few weeks or months later we are informed that yes, there is a problem after all. And yes, millions of pills are being recalled. But don’t worry, it’s only been going on for a few years. 

Generic Drugs from India Approved in Record Numbers:

Even though pharmaceutical manufacturers in India have received an increasing number of warning letters this year, the FDA has approved more generic drugs from India than ever before. In 2017, 27% of all generic drug approvals came from India. That number increased to 36% in 2018. In 2019 the number of drug approvals from India will represent 43% of all generic drug approvals in the U.S.

This trend may well continue. Hospitals are already experiencing substantial drug shortages. If the FDA were to restrict generic drug imports from China or India it is likely that these shortages would reach critical levels. Actually, drug shortages are already critical. So whatever comes after critical would occur if the FDA cracked down on foreign pharmaceutical firms. 

How Can Patients Get Their Drugs Tested?

Valisure doesn’t only test every batch of medications and supplements it sells. It also tests patients’ medications for impurities such as nitrosamines. You can learn more at www.Valisure.com  You can call about questions at 833-825-4787.

How do you feel about the FDA’s generic drug approval process? Do you find it odd that the FDA can issue so many warning letters to foreign pharmaceutical firms but continue to allow those very same companies to continue to export their products to the U.S.? Have you ever experienced problems with generic drugs? Has your medicine ever been recalled?

Share your thoughts in the comment section. You may also find our eGuide to Saving Money on Medicine of benefit. It reveals our challenging experiences with the FDA about generic drug approvals. There are also tips on using generic drugs safely. You will find this electronic resource in our Health eGuide section

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I check against the NDC list each ingredient in a generic that works for me. Then if a different one is given I check it against the other. I have found that local, not chain, pharmacies will order the generic medicine that I need. They will honor the co-pay even if it costs them more.

One article about nitrosamine mentions that it is also in hot dogs and other processed meats. How does the amounts in metformin compare? My family eats quite a few hot dogs, plus bacon and pepperoni occasionally, and one family member is also taking metformin ER–and took regular metformin for years. Are we, then, doubling up our risks or are these different risks?

I had chronic migraine for years and Zomig worked very well for me. After it went generic myself and others started reporting the pills were less effective. Of course, the medical community blamed the victim saying we were using too many pills instead of considering the generic concoction from India. Miraculously, a new preventative was invented last year that eradicated 95% of my migraine I dread the day it goes generic.

We patients are just screwed! Unless you are independently wealthy we have to take the generics our insurer allows. The FDA is not our friend–this extends to medical devices too. Changing drugs may not be of much value since they could also be contaminated, at some point down the line. It’s just a roll of the dice.

After reading your prior article on Losartan, I called my Optum Rx and asked if the pills I received from them were contaminated . They replied later that the batch I held was contaminated and to cease taking that med. Later they sent to me a container for me to return the med to them and I did on (10/10/19). To date I haven’t received any replacement.

Have been taking Metformin for two+ decades. This is very disturbing info. though unfortunately not surprising. Despite all of the “checks and balances“ and guidelines that are supposed to reassure and protect people, there are increasing numbers of ways to produce and sell defective/damaging products around the world. (Even in, gasp, the US.)
I have had no known experience with “contaminated” meds, but did have experience with ineffective generic Wellbutrin. After having been informed several times that the numerous changes in the appearance of the meds were due to different manufacturers but the med was “the same.” I took the most recent iteration for many refills before realizing that my level of agitation and teeth grinding was increased and occurring constantly. My dr. Informed me that “quite a few of his patients“ had had a similar experience.
While the effects did not appear to be life-threatening, they were certainly a problem.
So the “cheap” generic had to be traded in for the “expensive” name brand. Easy decision since the generic variety made me feel much worse, and the “real” one enabled me to stop the constant tooth grinding and intense irritation with all of life’s small moments. I am very fortunate that I am able to afford the meds that I am. What about folks with life-threatening conditions who cannot…

Isn’t it odd that Medicare, and Americans in general, are prohibited by law from buying drugs from Canada, Mexico, etc., due to possible safety concerns; but American Pharmaceutical companies are not prohibited from importing and selling drugs from countries that are known to have repeatedly serious manufacturing quality and safety violations? But we are forced by our health insurers to purchase these dangerous generics, instead of Brand name drugs made in America? The FDA has failed in its mission! Congress has failed the American public by accepting bribes from Big Pharma (in the form of campaign donations)! Doctors and pharmacists have failed us as well, by drinking the Big Pharma and FDA “Kool Aid.” Meanwhile, the price of “safe” meds skyrockets, and the entire industry, as well as our lawmakers, turns a blind eye! I no longer trust anyone involved in the US health care delivery system.

This is scary. I reported a shot called Prolia to the FDA, and they said there had not been enough complaints to act. I thought I would die from one shot, and it is hard to get the medical community to listen also. This has horrible side effects. Now I hear Metformin my be contaminated! I take 2 a day, and I also took Zantac for acid reflux. What are we do to for meds? This makes me so angry that all our health is put in the hands of a dept. that is not protecting us, the FDA.

I, too, experienced some wierd, disfiguring side effect after taking doxycycline, which also was ineffective at “curing” the condition for which it was prescribed. What HAS happened to the FDA? Where do we go now for the truth?

I took the contaminated valsartan from the Chinese manufacturer for years. I took Zantac as well. I agree with the other commenter that we can no longer trust the FDA. I have written to the FDA, to congress, and to anyone else who will listen. I have had the online pharmacy valisure.com test my valsartan to confirm the level of contamination with NDMA. What I do now is buy all of my prescriptions through Valisure. At least now I know that they are testing the medications. It is interesting to watch how defensive the FDA seems to get after these contaminations are identified. Frankly, a pharmacy like valisure should not have to exist if the FDA is doing its job. That said, I implore everyone reading this article to research their meds. Find out where they are made by asking your pharmacy. The more people who ask, the more the pharmacies will have to rethink their purchases from these manufacturers. If you want medications that are tested before they are sent to you, go to valisure.com and order it there. Finally, PLEASE write to your congressperson about this issue. Without people raising it, nothing will change. Money is the driver here. Think about it – cheap Indian and Chinese generics are great if they are safe. But with no one watching, there is opportunity to cut corners, like using cheap solvents (DMF) and you get by-products like NDMA. Who benefits? The generic manufacturer, your insurance company, Medicare, Medicaid, etc. There’s a lot of profit at stake here on the backs of everyday Americans!

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