Global health regulators have raised the alarm about the possibility that the widely used drug, Zantac, could be tainted with the same cancer-causing agent found in Valsartan earlier this year. Here, the pharmaceutical liability attorneys at The Law Offices of Peter Angelos detail the preliminary results of the FDA and EU probes.
Officials are Investigating If Zantac Contains Traces of NDMA
Drug safety officials in the U.S. and Europe have launched an investigation into whether Sanofi heartburn medication, Zantac, and other generic versions made by numerous manufacturers contain levels of the probable carcinogen N-nitrosodimethylamine (NDMA) that could pose a danger to patients.
Ranitidine, as the drug is known in its generic form, is an antacid and antihistamine used to treat and prevent a range of gastrointestinal disorders. A common industrial byproduct, the chemical NDMA is a likely human carcinogen that is also found in cooked or cured meats such as bacon.
The Challenges and Dangers of Global Oversight
The discovery further underscores the challenge pharmaceutical-industry regulators face in overseeing an enormous global supply chain of drugs, drug ingredients and factory processes. Last year, dozens of versions of the hypertension drug, Valsartan, were recalled out of concern they could be tainted with NDMA.
Many of those drugs were manufactured in countries such as China or India, raising questions about the quality of generic manufacturing in factories across the globe. There have been several reports on how poor quality controls and efforts to conceal manufacturing problems from the FDA have complicated oversight of overseas producers.
Zantac Contaminations Resemble Similar Cases of Contaminated Drugs in the U.S.
The recent discovery of the probable carcinogen NDMA in Zantac and generic versions reflects previous cases of carcinogens found in other drugs. The blood pressure drug Angiotensin II Receptor Blockers (ARBs) was recalled in 2018 after officials found that these drugs were contaminated with certain carcinogens. Specifically, types of ARBs such as irbesartan, losartan and valsartan were found to contain nitrosamines including NDMA, MDEA and NMBA, and this led to the recall of millions of pills from the market.
The FDA Has Released a Statement Regarding the Contamination
The FDA released a statement on September 13th, 2019, discussing the recent discovery that the drug Zantac and other ranitidine contain potentially dangerous levels of NDMAs. In it, the agency stated that they intend to take appropriate action immediately in order to protect patients and that they are currently investigating whether or not the amount of NDMAs found in ranitidine will pose a serious health threat to patients. The agency also advises that patients taking ranitidine discuss their treatment options with their health care professional. You can read the full statement here.
Generic Ranitidine Manufacturer Sandoz Has Halted Distribution of the Drug
As a response to the contamination of generic ranitidine, one manufacturer of the drug, Novartis’s Sandoz unit, has made the decision to cease the distribution of its product. The halt in distribution will continue indefinitely until further decisions are made regarding the safety of the product. While the FDA has not ordered a recall of the drug, the agency has stated that patients taking over-the-counter ranitidine should consider other options for treating their various health conditions and consult with their physicians.
Consult a Pharmaceutical Liability Attorney at The Law Offices of Peter Angelos
The recent discovery of traces of NDMAs in popular drug Zantac and other generic versions of the drug is alarming and demonstrates the necessity of mass-manufactured pharmaceutical drug companies to ensure proper steps are being taken to uphold public health. The pharmaceutical liability attorneys at The Law Offices of Peter Angelos urge you to contact our Baltimore office today if you or a loved one has taken Zantac or other ranitidine that were contaminated by NDMAs during manufacture.