This past September the U.S. Food and Drug Administration issued a statement warning that, “the FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer)…” Zantac, the brand-name version of the drug, is sold by Sanofi, but generic versions are widely sold.
Almost immediately major pharmacy chains, including Walgreens, Rite Aid and CVS, pulled the heartburn medicine Zantac and its generic versions from their shelves. The FDA has continued to investigate the source of the contamination and also the risk to patients. Patients taking the drug were strongly recommended to consult their doctors and that those who take over-the-counter versions should consider switching to a different medication.
On January 2, a California based independent laboratory filed a citizen petition with the FDA regarding ranitidine, They claim their research has found Zantac and generic equivalents appear to produce unacceptably high levels of cancer-causing NDMA when exposed to heat for as little as five days. The laboratory, Emery Pharma, found that a combination of heat and time could raise levels of NDMA, potentially while drugs are sitting in packaging well after being analyzed by their manufacturers. Emery Pharma is now urging the U.S. Food and Drug Administration to recall all forms of the widely used product.
According to Emery Pharma CEO Dr. Ron Najafi, “Even limited exposure of ranitidine to high heat, such as a hot car or delivery truck, could cause problems.” Currently there are no requirements for the drug to be shipped or stored in temperature controlled environments and exposure to high temperatures is a common occurrence during transportation and storage.
Last week several manufacturers began voluntary recalls based on FDA warnings and the findings of Emery Pharma. Appco Pharma LLC is recalling prescription ranitidine hydrochloride capsules and Northwind Pharmaceuticals is voluntarily recalling prescription ranitidine tablets (150 mg and 300 mg), manufactured by Glenmark Pharmaceutical Inc.
The research is still in its early stages, but all indications so far show that many ranitidine medicines – including Zantac contain low levels of the cancer-causing drug nitrosodimethylamine (NDMA). If you have taken Zantac and had a diagnosis of a primary cancer of the digestive tract, such as small intestine, colorectal, esophageal, liver, bladder, and pancreatic cancers, or if you have a blood related cancer such as leukemia, non-Hodgkin’s lymphoma, or multiple myeloma – it might possibly be related to Zantac use and you should seek legal advice.
Cancer patients who have taken Zantac are filing lawsuits in increasing numbers. The Federal Panel on Multidistrict Litigation is having a hearing next week to consider coordinating all federal lawsuits in the U.S. before a single judge to supervise the pretrial discovery in the individual lawsuits.
At Saunders & Walker we urge that if you are taking Zantac or a generic equivalent to please consult your physician or pharmacist and find out if you need a replacement. If you or a loved one took Zantac or a generic equivalent and have been diagnosed with cancer, please contact Saunders & Walker at 1-800-748-7115 for a free consultation and learn more about case eligibility and whether you may be entitled to financial compensation.
Admitted to practice law in all federal multidistrict litigation courts, the California State Bar and the Florida Bar. His philosophy is to provide aggressive, quality representations and seek fair compensation for individuals and their families who have suffered injury, death, or sexual abuse.