In a previous post, we wrote about the FDA’s investigation into the heartburn medication, Zantac, and other drugs containing ranitidine. The problem is that ranitidine has been found to contain N-Nitrosodimethylamine (“NDMA”), a suspected cancer causing agent in humans. As a result, Zantac and many other ranitidine containing products have been voluntarily removed from stores.
An independent lab, in California, Emery Pharma, conducted a study to find out where the NDMA in Zantac and similar drugs comes from. The study concluded that NDMA is produced when ranitidine is exposed to high temperatures, similar to those reached during shipping or storage:
Our preliminary data indicate that NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer.
The study recommends that ranitidine products be shipped and stored only in temperature controlled environments and that a warning be added to the label to inform consumers against storing Zantac in hot cars or otherwise at high temperatures.
If you or a loved on has developed cancer after taking Zantac, you may have questions about your legal rights. Please contact a Zantac attorney at Clark, Perdue & List for a free consultation.