Saturday, July 10, 2021 - Friday, July 16, 2021 - The Food and Drug Administration hedged their recall of ranitidine on April 1, 2020, by advising the American public that, even though they were unable to confirm Valisure‘s assertion of highly elevated levels of carcinogens in ranitidine, they decided it would be wise to exercise an abundance of caution. The FDA told the country‘s consumers Zantac, the best-selling brand of ranitidine heartburn and acid reflux medicine that neither they nor Sanofi the maker of Zantac could guarantee the storage conditions or establish an expiration date, the medicine should be pulled for further investigation. According to the FDA‘s Zantac recall declaration: "We didn‘t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don‘t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured." Zantac cancer attorneys offer a no obligation and free consultation before filing a Zantac lawsuit claim.
What the FDA did observe, however, was sufficient in their opinion to justify the recall. The FDA agreed with the conclusion of online prescription drug testing pharmacy
Valisure without confirming that ranitidine‘s NDMA levels had skyrocketed, despite Valisure‘s high-heat testing methods possibly accounting for the millions of nanograms of NDMA their labs found. The FDA tests found that drug transportation, storage, and consumption of ranitidine produced normal levels (96 nanograms of NDMA per tablet) in most and only slightly elevated levels in some. "NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers," the FDA wrote when recalling the drug."
The science that underlies the Zantac cancer claims will take center stage during Science day on September 30, 2021, in the United States District Court for the Southern District of Florida. Judge Robin Rosenberg has asked attorneys for both sides to present experts that will give their testimony regarding the safety of ranitidine or lack thereof. After much deliberation, the judge will decide which experts are most credible, and they will be able to give their testimony to independent juries for each plaintiff. Judge Rosenberg will not decide on the science itself as that is up to each jury. Zantac cancer trials are expected to begin in 2023. More than 70,000 individuals alleged that taking ranitidine (Zantac) regularly for more than one year caused them to develop various types of cancer like stomach cancer, bladder cancer, and colon cancer. Because cancer has a latency period of 5-10 years, Zantac cancer claims could continue to be filed for more than a decade. Sanofi‘s voluntary recall of Zantac in 2020 could have been a legal maneuver to put a cap on future Zantac cancer claims. The same has been said of Johnson & Johnson discontinuing to sell Johnson‘s Baby Powder in North America after thousands of women with ovarian cancer filed lawsuits.