In October, 2019, the Food and Drug Administration revealed it had found a chemical called nitrosodimethylamine (NDMA) – which could be linked to cancer – present in Zantac and generic versions of the heartburn and stomach ulcer medication. Subsequently, these medications, whose active ingredient is called ranitidine, were pulled from many drugstore shelves.
Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues.
More recently, the FDA disclosed additional recalls of medications containing ranitidine, including several versions of the medication intended to lower blood pressure.
To have a valid claim, patients will need to confirm that they took Zantac or a generic version of the drug regularly for an extended period of time, and that they indeed have a cancer diagnosis.
In addition, they will need to meet the following more specific requirements:
For typical adult case:
At least 5 years of Zantac (ranitidine) exposure prior to cancer diagnosis.
Minimum of 300 mg/week during 5-year period of exposure.
No more than 10 years since last Zantac (ranitidine) exposure prior to cancer diagnosis.
For prenatal exposure case:
At least six months of Zantac (ranitidine) exposure during pregnancy.
Minimum of 300 mg/week during 6 months of pregnancy.
No more than 5 years after birth for diagnosis of cancer.
For pediatric exposure case:
At least 2 years of Zantac (ranitidine) exposure prior to cancer diagnosis.
Minimum of 150 mg/week during 2-year period of exposure
No more than 1 year since last Zantac (ranitidine) exposure prior to cancer diagnosis.
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