The US Food and Drug Administration (FDA) has issued a nationwide recall, calling for the immediate pullout of all over-the-counter and prescription ranitidine drugs under the Zantac brand name. The FDA made the call on Wednesday stating that its ongoing investigation has found dangerous levels of contaminants in the medication.
The agency stated that it has found that the amount of contaminants in the drug could increase over time to dangerous levels when it is stored at higher-than-normal temperatures. Taking medications with high levels of contaminants could pose a health risk for patients.
According to the FDA, it discovered that drugs that were stored contained a high dose of N-nitrosodimethylamine or NDMA. The contaminant is considered a carcinogen, which means that it could lead to the growth of cancerous tumors when taken in high doses. The agency's investigation into the drug and its contaminants reportedly began during the summer of last year.
The director of the FDA's Center for Drug Evaluation and Research, Dr. Janet Woodcock, mentioned in an announcement that they didn't find unacceptable levels of the contaminants in the samples they tested. However, because they could not determine how long the products had been stored in most cases led them to decide to simply recall the products to ensure the safety of consumers.
Woodcock added that they are continuing their efforts in tracking impurities of other drugs to ensure that patients can still use them without any health risks. As of the moment, the agency has sent letters to all manufacturers and distributors, requesting them to immediately withdraw products from all markets and advises consumers to immediately stop taking Zantac.
The FDA advised manufacturers and distributors to also dispose of the drugs they have in storage and not to purchase any more stocks. In light of the ongoing viral pandemic, the FDA advised people not to return their already purchased medicine to avoid getting infected. Instead, the agency stated that consumers should follow proper disposal instructions placed in the medication insert or at the agency's website.
Patients who are medicating with Zantac can opt to use alternative products that have been approved by the FDA and found to have no NDMA contaminants. These alternate drugs include Pepcid, Nexium, and Prilosec. The FDA noted that patients should consult with their doctors before shifting to other treatment options or before they decide to stop medicating altogether.
Sanofi, one of the drugmakers that produces the drug, issued a voluntary recall of the Zantac OTC it had sold in the United States and Canada. The company issued the recall in October of last year after revealing that it found inconsistencies in its internal test results.
