Prescription-Strength Zantac Recalled By GlaxoSmithKline Over NDMA Fears
GlaxoSmithKline is recalling all prescription-strength Zantac products worldwide this week, due to concerns the heartburn drug may expose users to cancer-causing chemical.
The prescription-strength Zantac recall was announced on October 8, by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in an alert to healthcare professionals. The recall affects all unexpired stock of prescription-strength Zantac in all forms, including tablets, injection and syrup.
The recall does not affect the brand-name over-the-counter versions of the drug, which are manufactured by other companies. A number of generic manufacturers have also issued recalls for over-the-counter versions of Zantac as well.
Concerns over the potential Zantac cancer risk emerged last month, when the online pharmacy Valisure found high levels of the chemical N-nitrosodimethylamine (NDMA) in all versions of the heartburn drug and submitted a citizen’s petition with the FDA to have it pulled from the market. The FDA issued a warning about the Zantac NDMA contamination on September 13.
NDMA detected in Zantac is a chemical byproduct, which the World Health Organization has described as “clearly carcinogenic.” Long-term exposure has been linked to reports of liver cancer, stomach cancer, esophageal cancer and other digestive tract cancers when the chemical was found in other pills.
Valisure reported that tablets of Zantac may contain 26,000 times the permissible daily intake limit set by the FDA for NDMA, which indicates that levels should not exceed 96 nanograms per day.
The recall impacts all unexpired stock of Zantac (ranitidine hydrochloride) prescription-only medicines. This includes 150mg and 200mg Zantac Tablets, 150mg/ml Zantac Syrup, and 50mg/2ml Zantac Injection.
MHRA officials said the recall came at their request.
“We have asked companies to quarantine batches of potentially affected medicines whilst we investigate and we will take action as necessary, including product recalls where appropriate,” Dr. Andrew Gray, MHRA Deputy Director of Inspections, Enforcement & Standards, said in a press release. “We have also requested risk assessments from the relevant companies which will include the testing of potentially affected batches.”
The announcement came just days after the FDA issued an update on its own investigations into NMDA Zantac contamination, warning that it found “unacceptable” levels of NDMA in the medication even when using more forgiving testing methods than those used by Valisure.
NDMA has been a focus of FDA attention over the past year, after the chemical was detected in the various different generic blood pressure drugs last year, resulting in hundreds of valartan lawsuits brought by former users who indicate they developed liver cancer, colorectal cancer and other cancers following long term exposure to the tainted drug.
Investigations stemming from the valsartan recalls suggest that NDMA entered that blood pressure medication due to changes in the generic drug manufacturing process, which caused the chemical byproduct. However, the cancer risk with Zantac appears to be an inherent element of the medication, with reports suggesting that the active ingredient ranitidine is unstable, and creates NDMA as a byproduct in the body.
Zantac has been on the market since 1983, and was the first “blockbuster” drug to have sales surpass $1 billion per year.
Drug manufacturers already face several Zantac class action lawsuits filed in recent days. In addition, they are expected to face individual Zantac lawsuits brought on behalf of individuals diagnosed with cancer following use of the drug.