As of early September, the Food and Drug Administration (FDA) made an announcement regarding low levels of N-nitrosodimethylamine (NDMA), a cancer-causing element, found in ranitidine.
Ranitidine is the active ingredient found in the heartburn medication, Zantac. NDMA is an environmental contaminant classified as a probable carcinogen in studies on animals. Human studies are very limited at this time, but more information will become available as further tests are conducted. If you or someone you love has taken Zantac for heartburn relief, you or your loved one may be entitled to damages in relation to the recent recall.
The original testing directed by Valisure Online Pharmacy found “extremely high levels” of NDMA in ranitidine, but subsequent FDA tests found low levels of the impurity.
In response, the FDA has asked all companies manufacturing ranitidine to test their drugs with lower heat levels that are close to the average human body temperature.
In addition, the FDA requested that companies who manufacture medications similar to ranitidine are also tested, such as both H2 blockers, the class of drugs that ranitidine belongs to, and proton-pump inhibitors.
At this time, there is no reason to believe these other products have been affected. The FDA has requested these tests as a precautionary measure.
Zantac is sold in both over-the-counter and prescription forms and is in a drug class known as H2 (histamine- 2) blockers. Over-the-counter versions are mainly used to treat heartburn. Prescription versions are designed for the treatment and prevention of more serious ulcers found in the stomach and intestines.
Since the recall, the following drug companies have removed all of their generic ranitidine products in the United States:
Perrigo Company PLC
Novitium Pharma LLC
In addition, major drugstore chains such as CVS, Walgreens, and more have pulled Zantac as well as other generic heartburn medications from their shelves.
It is essential to note that the NDMA found in ranitidine products is not an immediate risk to your health. Even though NDMA is classified as a probable carcinogen, the risks of cancer are only relevant to those who have ingested high doses of the drug over a lengthy period of time.
The FDA and other institutions across the globe will continue to investigate ranitidine for more information about the impurity. In the interim, the FDA has not called for people to halt using the medication. Similarly, the drug is only suggested for short-term use.
If you have been taking ranitidine for a long time, it is a good idea to speak with your doctor right away about whether you should continue taking the drug. In addition, it is also wise to ask if there is an advantage to taking different medication options, like other drug classes or another H2 blocker.
Based on the studies conducted thus far, there is no proof that NDMA impurities impact other H2 blockers or other heartburn medications. Studies conducted by the FDA found that the following medicines do not contain NDMA:
Although antacids may be effective for heartburn relief, there are other methods as well. Lifestyle changes, such as avoiding certain foods and drinks, may also help block heartburn episodes.
If you or someone you love has been taking Zantac or another ranitidine medication for heartburn relief, you may have a product liability case. The accomplished attorneys at Goodman Acker have extensive experience in the field of product liability law. Our firm has recovered millions on behalf of clients in order to right some of the wrongs that have occurred. We can help you, too. Don’t hesitate to contact us with your product liability case right away.
Call Goodman Acker today at (248) 793-2010 if you’ve been taking Zantac or other ranitidine medications for heartburn relief.
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