Zantac Has Low Levels of a Cancer-Causing Chemical, the F.

The Food and Drug Administration said on Friday that it had detected low levels of a cancer-causing contaminant in samples of heartburn medicines containing the drug commonly known as Zantac.

It was advising patients who take over-the-counter versions to consider switching to a different medication.

But no recalls have been initiated, and the agency said patients who take prescription versions of the drug, known as ranitidine, should consult with their doctors before stopping. The European Medicines Agency is also looking into the issue.

Zantac, the brand-name version of the drug, is sold by Sanofi, but generic versions are widely sold. The F.D.A. has not identified any specific products that were affected.

A spokeswoman for Sanofi said the company does not plan to recall the product.

“Sanofi takes patient safety seriously, and we are committed to working with the F.D.A.,” the spokeswoman, Ashleigh Koss, said in a statement. The over-the-counter version of Zantac “has been around for over a decade and meets all the specified safety requirements for use in the O.T.C. market.”

A trade group for over-the-counter drug manufacturers, the Consumer Healthcare Products Association, noted that the F.D.A. had not called for recalls, and that products containing the drug “play an important role in helping consumers manage their symptoms and treat heartburn.”

The contaminant, a type of nitrosamine called N-nitrosodimethylamine, or NDMA, is the same one that was found in some versions of valsartan, a blood-pressure drug carrying the brand name Diovan. The discovery of NDMA in valsartan led to several recalls of the commonly prescribed drug, which in turn led to supply shortages.

The valsartan recalls have renewed questions about the safety of the American drug supply, particularly of generic drugs, composed of raw ingredients that are frequently manufactured in countries like China and where F.D.A. oversight has lagged.

“I think this is another good example of how our regulations need to change,” said Dinesh Thakur, a drug-safety advocate who exposed widespread quality problems as a former executive at the Indian drug maker Ranbaxy Laboratories. He said the F.D.A.’s testing is too lax. “Things like this will never get caught, unless somebody is actually actively looking for stuff.”

in STYLN_email_trump-0_control_STYLN_email_trump

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]

Nitrosamines can cause tumors in the liver and other organs in lab animals, and are believed to be carcinogenic in humans. NDMA can form during manufacturing if the chemical reactions used to make the drug are not carefully controlled and monitored, the F.D.A. has said.

Jeremy Kahn, an agency spokesman, said Friday that the agency is still investigating contamination of the heartburn drugs, and that it is unclear how many companies’ products are affected and how the problem originated. However, he said, “We tested a small number of products for this impurity, and all of the products we’ve tested so far have had NDMA at low levels.”

He said that the levels were not high enough that the agency was recommending recalls so far, noting that low levels of NDMA are also found in other drugs and in food products. The agency first learned that some samples of ranitidine contained the chemical in June, after it tested the product in the wake of the valsartan recalls.

The agency’s announcement came on the same day that an online pharmacy, Valisure, petitioned the F.D.A. to request a recall of all products containing ranitidine, because it said its own tests had revealed high levels of NDMA, above the F.D.A.’s acceptable daily limit. The Valisure petition speculated that the source of the NDMA was the result of the “inherent instability” of the ranitidine molecule, which can degrade under certain conditions, such as when it is digested, to create NDMA.

“Our feeling is that this is extremely troublesome,” said David Light, the chief executive of Valisure, which is based in Connecticut. “We took it off our formulary right away.”

Mr. Kahn said the agency does not yet know whether the NDMA was a result of the instability of the drug, but he did say that the F.D.A. believed the source of the problem was separate from the ones that arose in the valsartan case.

The source of the contaminated valsartan was a Chinese manufacturer, Zhejiang Huahai Pharmaceutical Company. Major Pharmaceuticals, Teva Pharmaceutical Industries and Solco Healthcare, which is owned by Huahai Pharmaceutical, sold it in the United States.

The same type of impurities were later found in two other blood-pressure drugs, irbesartan and losartan, in the same class as valsartan. Two more nitrosamines — nitrosodiethylamine, or NDEA, and N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA — were found in the drugs. Lists of the affected products are posted on the F.D.A. website.

In March, the F.D.A. approved a new version of generic valsartan to relieve the shortage, and the companies that recalled their products have begun returning versions of the drug that are not contaminated to the market, Mr. Kahn said.

More Coverage of Drug Contamination

New Generic Blood Pressure Drug Is Approved to Relieve Shortages

March 12, 2019

Blood Pressure Medicine Is Recalled

July 16, 2018
Related news

Vegan influencer slammed for going ‘full on carnivore’ for 30 days & claims it’s made her ‘more focused and healthy’.

A VEGAN influencer has been slammed by fans for going “full on carnivore” for 30 days – and she claims it made her “more focused and healthy”. Alyse Parker posted a video on her YouTube channel earlier this month wher...

Scarlet fever outbreak hits UK as 480 children infected across England and Wales in 1 week.

DOCTORS have reported a scarlet fever outbreak after hundreds of children were infected across England and Wales in just one week. The highly-contagious disease, which used to kill thousands back in the 19th century, is now on the rise – par...

Weight loss: The best carbs to eat to shed pounds – based on your body type.

THEY are often deemed the enemy when it comes to weight loss – with many believing they ruin an otherwise good diet. However, it seems as though carbs actually have an unnecessary rep – as one expert has finally debunked this myth. In ...

1

Products to keep your hangovers at bay and bath salts for pre-party sessions.

THE average Brit suffers three hangovers a month – with the booze causing a gut bacteria imbalance which can lead to a lower immune system. So getting your microbial diversity right can help keep an epic hangover, or cold, at bay. We trialled what...

Measles outbreak declared in American Samoa, shuttering schools.

In the neighbouring independent nation of Samoa, more than 60 people have died, mostly children, from the measles and more than 4,000 were infected since the outbreak started in mid-October, health officials said.

1

Продовжуючи переглядати World News (UAZMI), ви підтверджуєте, що ознайомилися з Правилами користування сайтом, і погоджуєтеся на використання файлів cookie