NEWARK, N.J.--(BUSINESS WIRE)--Class-action law firm Hagens Berman which filed the first lawsuit regarding Sanofi and Boehringer Ingelheim’s intentionally concealed cancer risks in its popular heartburn medication, Zantac, has issued a fact sheet to set the record straight about what attorneys are calling glaring incompetence and shameful conduct from the FDA to date in connection with Zantac.
“The FDA’s response with respect to Zantac, in our opinion, is a public disservice and constitutes reckless behavior for an agency tasked with protecting the people,” said Steve Berman, managing partner of Hagens Berman and attorney leading the case for consumers. “The FDA has become a shell of an agency. Its job is to protect the public from harmful drugs. Instead, it seems determined to protect the big pharmaceutical companies by perpetuating the secret these companies have kept from the public for nearly 35 years: that when ingested, Zantac (or generic ranitidine) breaks down into a potent carcinogenic substance inside the body.”
“We are not going to sit idly by, while the FDA continues to encourage pregnant mothers who suffer from pregnancy-related heartburn and others to keep taking Zantac, while the FDA continues to dither and spread misinformation presumably in an effort to mask its incompetence,” he added.
“Even though the FDA first learned in June 2019 about the possibility that a carcinogen was associated with Zantac, it waited nearly three months before it issued its first piece of disinformation concerning Zantac. Since its first public statement on this issue, it has deliberately sought to try to pretend that issues with Zantac are limited to the same as those discovered with Valsartan,” Berman said. “Let me be clear since the FDA is not: This is not even close to Valsartan.”
“As we allege in our lawsuit, filed Sept. 20, 2019, in the U.S. District Court for the District of New Jersey, and we intend to prove, there is a fundamental defect with Zantac: when ingested, it forms a potent carcinogen (NDMA) in your body that exceeds FDA permissible intake limits by thousands of times,” he said. “In other words, all Zantac and generic ranitidine put one at risk of ingesting potent carcinogens. Instead of informing the public of this, the FDA is seeking to mischaracterize the situation with Zantac as one involving an ‘impurity’ and has asked the big pharmaceutical companies to perform tests that are intentionally designed to miss the key issue: that Zantac is an inherently dangerous drug. It is time someone speaks the truth about what is going on and we intend to speak that truth.”
ZANTAC/RANTITIDINE FACT SHEET: WHAT THE FDA IS MISSING ON NDMA TESTING
- Online pharmacy and laboratory company Valisure conducted an initial test on Zantac using the very test that the FDA recommended be used to test for N‑nitrosodimethylamine (NDMA). This test showed abnormally high amounts of NDMA in Zantac.
- Valisure determined, as has the FDA itself, that the reason NDMA levels were so high was because the FDA’s own testing protocol calls for the sample to be heated to 130 degrees Celsius and in doing so, the heat itself reportedly caused some or all of the NDMA formation.
- Because Valisure was concerned the FDA’s testing methods may not be suitable for ranitidine, Valisure conducted other well-established tests designed to more closely mimic the human body, which involved heating the sample up to only the temperature of the human body.
- Other tests also detected NDMA levels exceeding the FDA permissible NDMA intake levels by nearly 3,100 times.
- In addition to the Valisure tests, a recent study was conducted by Stanford and Syracuse faculty on the urine of humans both before and after they took Zantac. Alarmingly, the urine of the human subjects contained levels of NDMA that exceed FDA permissible NDMA intake levels by between 250-400 times. Worse yet, the authors of this peer-reviewed study posit that these NDMA levels are likely very low since nearly 99 percent of all NDMA is absorbed in the body and not excreted in urine.
- Valisure filed a Citizen Petition with the FDA on Sept. 13, 2019 seeking to have the agency pull ranitidine drugs from the market and create viable tests for NDMA in them. The FDA has failed to publish the Citizens Petition (or make it available to the public) so the medical community or other scientists could examine it.
- Valisure in a statement said that contamination of ranitidine products is a concern, but the bigger problem is the instability of the ranitidine molecule itself: "the significantly more serious problem is ranitidine's potential to form millions of nanograms of NDMA, a known carcinogen, in the human body.”
The FDA has failed to mention these facts, either directly or indirectly, and has still failed to call for the stoppage of the sale of Zantac, or for the public to halt its consumption. Instead, it shockingly is encouraging people to continue taking Zantac. Attorneys doubt that the FDA staff is giving their own family that same advice.
The law firm is urging those who take Zantac to consult with their doctors before continuing to take the medicine.
Walmart, Walgreens, Rite Aid and CVS Health have already suspended the sale of Zantac. Canada’s FDA-equivalent, Health Canada, is urging manufacturers to stop the sale of drugs containing ranitidine. Regulators in South Korean, Germany and Bangladesh have also asked for temporary recalls until more testing is done. Sandoz had agreed to recall its ranitidine products worldwide including in the U.S.
“When retailers like Walmart, or pharmaceutical companies like Sanofi are left to police themselves, it is clear that the federal agencies in place to protect the public are failing to do their job,” Berman said. “The FDA’s handling of this serious health concern is only causing confusion.”
If you have concerns about any potential adverse health risks associated with Zantac (or generic ranitidine consumption), Hagens Berman recommends that you discuss the allegations in this lawsuit with your physician.
Hagens Berman Sobol Shapiro LLP is a consumer-rights class-action law firm with nine offices across the country. The firm’s tenacious drive for plaintiffs’ rights has earned it numerous national accolades, awards and titles of “Most Feared Plaintiff’s Firm,” and MVPs and Trailblazers of class-action law. More about the law firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.