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Ranitidine (Zantac) recall expanded, many questions remain

Update: On April 1, 2020, the FDA requested manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs (Zantac, others) from the market immediately, due to the presence of a contaminant known as N-Nitrosodimethylamine (NDMA). Although the FDA did not observe unacceptable levels of NDMA in many of the samples they tested, they have determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures. As a result of this recall, ranitidine products will no longer be available for prescription or OTC use in the US.

The FDA is also advising consumers taking OTC ranitidine to stop taking this medication, including any unused ranitidine medication they may still have at home. Other FDA-approved OTC medications are available to treat heartburn. Patients taking prescription ranitidine should speak with their doctor about other treatment options before stopping the medicine.

As anticipated, recall of the popular heartburn medicine ranitidine (Zantac) has expanded. But we still have more questions than answers.

As I mentioned in my original blog post on this topic, the online pharmacy Valisure, which originally alerted the FDA to the issue, found what they called “extremely high levels” of the probable cancer-causing substance N-nitrosodimethylamine (NDMA) in ranitidine products.

The FDA has indicated that its own preliminary testing has detected low levels of NDMA in ranitidine.

Testing methods may have influenced NMDA results

The FDA has clarified that the testing method that found the “extremely high levels” of NDMA applied high heat, at a level much higher than normal body temperature. In other words, the testing did not reflect typical conditions under which the medication would be stored or taken.

The FDA is asking all companies that manufacture ranitidine, as well as other similar medications (both H2 blockers, the class of drugs to which ranitidine belongs, and proton-pump inhibitors, or PPIs, a different class of drugs used for similar con

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Written by Shobha

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