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Another BP Nitrosamine Drug Recall and Zantac (Ranitidine)

You won't believe this. There is a nitrosamine drug recall for the BP med losartan. Other countries are recalling ranitidine (Zantac) for heartburn. Why?

Are you getting drug contamination fatigue? We would not blame you. There is a new blood pressure nitrosamine drug recall. This time it is from Torrent Pharmaceutical Limited of Ahmedabad, India.

The company announced on September 23, 2019 that several lots of its 50 mg and 100 mg bottles of losartan and losartan + hydrochlorothiazide were contaminated with NMBA. This comes just days after Canadian, European and Taiwanese drug regulators announced the recall of ranitidine (Zantac) because of the nitrosamine NDMA.

Are You Getting Tired of the Nitrosamine Drug Recall?

Remember the boy who cried wolf? The story tells about a boy charged with guarding sheep. He thought it would be a good joke to cry wolf and have the villagers come running. Two times they came and there was no wolf. They didn’t pay attention the third time he cried out and the wolf ate his sheep.

Sadly, the nitrosamine drug recall problem is all too real, but we are beginning to feel like that little boy. We have cried wolf so many times it almost seems as if no one is listening anymore, even though there really has been a wolf each time. The Food and Drug Administration seems content to let contamination fatigue set in.

The Sartan Scandal:

Here we go again. Another day, another drug contamination crisis! Ever since the valsartan blood pressure pill scandal over a year ago, FDA officials have been playing catch up.

The agency was caught flat-footed when European drug regulators started warning physicians and patients that millions of sartan-type pills were contaminated with probable carcinogens.

The first warning about valsartan came from the European Medicines Agency on July 5, 2018. We sent out our first Special Health Alert from The People’s Pharmacy on July 15, 2018. Chinese-made valsartan was contaminated with NDMA (N-nitrosodimethylamine). This was the first nitrosamine drug recall.

We reported that over 16 million valsartan prescriptions were dispensed every year in the U.S. There have been countless recalls of valsartan, irbesartan and losartan since. Millions of people have been affected and tens of millions of pills have had to be trashed.

New Losartan Recall

Torrent just announced its nitrosamine drug recall recall of losartan (50 mg and 100 mg pills) because of NMBA (N-Nitroso-N-methyl-4-aminobutyric acid). This now makes over 300 lots of blood pressure medications that Torrent has recalled since last summer.

If 300 lots doesn’t sound like much, consider that many of these lots involve bottles that contain 1000 pills. We love it when a company tells you to check for a lot number on your bottle of pills to determine whether your medicine is affected. This is almost always a fruitless task.

Pharmacists pour pills out of big bottles (with 1000 pills) into little amber bottles and slap a label on them that was generated by a computer. Rarely, if ever, does that label contain a lot number. That means that you may not be able to identify whether the most recent nitrosamine drug recall affects you.

Other companies that have recalled sartan-type BP drugs include some of the biggest generic manufacturers in the world. They include Mylan, Teva, Sandoz Novartis, Macleods, Aurobindo, Camber, Major and Prinston to name a few.

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Another Nitrosamine Drug Recall: Ranitidine/Zantac

The FDA has also been blind-sided by another contamination calamity. This time it’s not a blood pressure medicine, though. It’s a widely used heartburn drug known as ranitidine (Zantac).

An online pharmacy called Valisure tests all batches of drugs it dispenses for quality and purity. After testing Zantac and various generic ranitidine products, the company sent a Citizen Petition to the FDA.

It says in part that Valisure’s tests:

“…detected extremely high levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine. The Food and Drug Administration (“FDA”) has established a permissible daily intake limit for the probable human carcinogen, NDMA, of 96 ng. Valisure has detected NDMA in excess of 3,000,000 ng per tablet when analyzing ranitidine products, likely due to the inherent instability of the ranitidine molecule.”

Not surprisingly, the FDA is scrambling. In an interview with Bloomberg (Sept. 13, 2019), the FDA’s director of the Center for Drug Evaluation and Research, Janet Woodcock, said that the agency had detected NDMA in OTC and prescription versions of Zantac.

She went on to add:

“We don’t think this poses an immediate hazard to human health so we’ll have an ongoing process to determine whether recalls are needed.”

The FDA has tried to reassure the millions of people who took contaminated irbesartan, losartan and valsartan blood pressure pills that the cancer risk was too low to worry about. But judging from the messages on our website, patients are not placated.

One reader wrote:

“I took Valsartan for over three years. Now I have lung nodules that have been followed for two years. I’d like to know just what this drug causes, as far as damage to an organ system. I’m not a smoker and never have been. I just hope my nodules aren’t related to having taken this medicine.”

We may never know how many cases of cancer might have been caused by contaminated blood pressure pills or tainted ranitidine. The FDA can reassure people that the risk is small, but that is little comfort to our readers.

Valisure Says: Recall Ranitidine!

Valisure, the company that discovered the contamination of ranitidine/Zantac, has strongly suggested that the FDA:

“…recall and suspend sale of all lots of all products containing ranitidine.

“In addition to the instructions for disposal and/or return in the recall notices, issue additional guidance to the public for the safe disposal of ranitidine, given the recognized potential that the drug may degrade to form the probable carcinogen NDMA in municipal wastewater treatment plants and impact the public water supply.”

Other countries are taking Valisure’s advice. We have discovered that Taiwan’s FDA has recalled 38 stomach medications containing ranitidine. Canada and some countries in Europe are also recalling ranitidine and/or Zantac. 

We find it distressing that the FDA did not discover this contamination problem on its own. We are also alarmed that the agency seems more concerned about reassuring the public than issuing a recall at the time of this writing.

We have been alerting readers of The People’s Pharmacy about our concerns involving the manufacturing, shipping and storing of drugs for years. Just listen to our interview with Katherine Eban about her book, Bottle of Lies: The Inside Story of the Generic Drug Boom to get some idea of the size and scope of the problem. 

Stay tuned; we may be crying wolf, or rather “nitrosamine drug recall,” a few more times before this story is finished.

What Do You Think?

Share your thoughts about the nitrosamine drug recall in the comment section at the bottom of the page. Do you find the FDA’s actions laudable or deplorable? Are you concerned that so many drugs have been contaminated with nitrosamines or do you think this is a minor annoyance at worst? We would like to read your perspective.

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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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