FDA Issues Voluntary Manufacturers’ Recall of Antacid Drug, Zantac
Due to the extensive (and necessary) press coverage devoted to the Coronavirus (COVID-19) epidemic, many of us may have missed news regarding the U. S. Food and Drug Administration’s (FDA) request that manufacturers of the popular stomach acid-blocking drug Zantac (ranitidine) voluntarily remove their products from the U. S. market. The FDA’s action comes six months after independent testing laboratories found that an impurity in the drug could, under certain conditions, break down to form the known carcinogen (cancer-causing chemical) n-nitrosodimethylamine (NDMA). In laboratory animals, NDMA has been linked to cancers of the liver, kidney, and the lining of the nasal cavity.
The FDA’s action asking manufacturers of the generic and over the counter (OTC) brands of ranitidine to voluntarily remove their products from U. S. markets stops short of the more far-reaching mandatory recall, which would allow criminal penalties to be assessed against those manufacturers who refused to comply with an FDA recall order.
For those who have been taking ranitidine (Zantac) to treat chronic or food-associated heartburn as well as gastro-esophageal reflux disease (GERD), and wisely wish to switch to another drug, the following OTC and prescription-strength medications have been tested by the FDA and have been found to be free of NDMA and are felt to be just as effective as ranitidine:
Zantac (also known by its generic name of ranitidine) is available in two forms and dosages. In it prescription-only form, Zantac (ranitidine) is dispensed by a pharmacist in a usual strength of 300 mg per tablet. In its OTC form, ranitidine (often labeled as “Equivalent to Zantac”) is sold in tablets containing either 75 mg(“Regular” strength) or 150 mg (”Extra” strength) per tablet.
Ranitidine belongs to a class of drugs called “H2 Blockers” or H2 Inhibitors.” These drugs act to prevent the release of stomach acid (chemical symbol H2) caused by certain foods or other drugs. Thus, ranitidine is used in conditions caused by an excess of stomach acid or made worse by even normal amounts of stomach acid.
In June of 2019 the online discount pharmacy Valisure which, according to its website, conducts routine testing on every batch of each medication that it sells, notified the FDA that its analysis of ranitidine products had detected unacceptable levels of the cancer-linked chemical NDMA. In September, Valisure petitioned the FDA to recall all drugs containing ranitidine on the grounds that the ranitidine molecule was “inherently unstable” and could undergo chemical reactions under a variety of conditions that would release NDMA. In March of this year the FDA granted that petition, but made the recall “voluntary” rather than mandatory.
In laboratory animals, even small amounts of NDMA (much less than the amounts detected in the Valisure analysis) have been linked to cancers of the liver, kidney, and the lining of the nasal cavity. According to Valisure CEO David Light: “There’s no acceptable cancer risk for a drug like this…”
If you or a family member regularly took the drug Zantac (ranitidine) have been diagnosed with cancer, we invite you to contact the dangerous drug lawyer at The Doan Law Firm to arrange a free, no-obligation, review of the facts in your Zantac cancer case and a discussion of the legal options that may be available to you.
When you contact out firm, there is never a charge to review the facts of your Zantac cancer case or to speak with our dangerous drugs lawyer to review the legal avenues that may be open to you. And, unlike some law firms, our free case review and first consultation with our dangerous drugs lawyer do not obligate you in any way to hiring our firm to act as your legal counsel. Should you later decide that a lawsuit is in order, and that you would like for us to represent you in court, we are willing to assume full responsibility for all aspects of preparing your case for trial in exchange for an agreed-upon percentage of the final settlement that we are prepared to win for you.
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