FDA decision adds to the suspicion that Ranitidine may cause cancer


Suspicions that ranitidine causes cancer to deepen following the FDA request for a full withdrawal of the drug

The FDA recently requested that sellers and manufacturers of drugs containing ranitidine withdraw all over-the-counter and prescription drugs from the market immediately. Any doubts surrounding their initial findings of unacceptable levels of NDMA, cancer-causing contaminant instantly disappeared

This decision cemented their further findings that the impurity levels in these products can even increase when they’re stored in an abnormal fashion. This decision means that all ranitidine products are no longer legally available for sale, either by prescription over the counter in the US.

What advice has the FDA given to consumers

The FDA explicitly stated that anyone who has a product containing ranitidine must stop taking the medication immediately. This includes ant unused medicines they may have in their home. The FDA has indicated there are many other medications, both prescription and OTC, that can be used to treat heartburn. They also recommend that you meet with your physician to discuss testing and any other treatment options available.

The popular medication Zantac has been included in this recall. Despite this, there are many questions that need to be answered. There seems to be a disparity between the FDA results that indicated lower levels of NDMA and the results of an independent pharmaceutical testing company Valisure, who initially brought the drug to the FDA’s attention. Independent testing found what they described as extremely high levels of NDMA in a series of ranitidine products.

Experts speculate that the methods used to test may differ.

When questioned about this, the FDA explained that the initial tests performed by Valisureperformed had applied heat that was much higher than average body temperature. They’re saying that the test did not reflect what would be considered standard conditions that the medication would be either taken or stored in.

As a consequence, the FDA has asked all pharmaceutical companies who manufacture ranitidine or any medications that are similar to thoroughly test their products using heat levels that are closer to average body temperatures. To date, no new data is available to indicate whether these other products that have been tested are affected in the same fashion. in all probability, the FDA is just being thorough by asking for these tests

What has the FDA said about NDMA risks attached to other medications

As yet, the FDA has not released the results that they conducted on ranitidine themselves. They were worried the impact on NDMA might be similar to angiotensin receptor blockers. When they tested this product, it was also withdrawn as they believed it posed any risk of cancer. The primary drug that was tested is called valsartan, and it’s mainly used to treat heart conditions and high blood pressure. This drug was recalled last year due to its contamination levels of NDMA.

What impact it will finally have on the current connection between MDMA and Zantac is yet to be seen. Still, one thing is clear if you are taking ranitidine products, you should look for an alternative until this issue is resolved either way.