Citing Increased Cancer Risk, FDA Recalls Zantac

| Jul 13, 2020 | Injuries, Medical Malpractice, Products Liability

Federal investigators found high levels of a known carcinogen in some Zantac pills. The Food and Drug Administration urged Sanofli to recall the product, and the manufacturer complied.

Testing indicated elevated levels of N-Nitrosodimethylamine, a highly toxic chemical often found in manufactured products. The levels increased along with Zantac’s shelf life. As a result, the Food and Drug Administration advised consumers to immediately stop taking over-the-counter Zantac. People taking prescription Zantac should keep taking it for now. But they should promptly call their doctors and arrange for a replacement. Initially, “We didn’t observe unacceptable levels of NDMA in many of the samples that we tested,” explained the FDA’s Dr. Janet Woodcock. “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,” she added.

“The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern,” she promised.

Zantac and NDMA

N-Nitrosodimethylamine is a common manufacturing by-product. At low levels, it is common in purified drinking water, rocket fuel, cured meat, and other consumer and industrial products. 

It is also extremely deadly, even at relatively low doses. Rather famously, in 2013, Chinese medical student Lin Senhao laced the dormitory’s drinking water cooler with NDMA to poison Huang Yang, his roommate. Yang subsequently died. Although Senhao claimed the poisoning was an April Fools joke which went awry, he was executed in 2015.

For reasons that are not entirely clear, perhaps because it has some bacterial qualities, heat causes NDMA molecules to multiply. This fact is an issue for many over-the-counter drugs. These drugs spend most of their lives in trucks, on store shelves, and in medicine cabinets. 

For example, in 2018 and again in 2019, regulators recalled some batches of Diovan, a popular diuretic and coagulant, because of high NDMA levels. Even more recently, in May 2020, the FDA issued a voluntary recall notice for Metformin, a diabetes drug.

The U.S. government classifies NDMA as an extremely hazardous substance. It has been conclusively linked to liver tumors in laboratory animals.

As mentioned, NDMA is a manufacturing by-product. It does not magically appear in Zantac or anything else. Manufacturers should be mindful of this risk and look for evidence of contamination. But they often ignore these risks, mostly because of the two figures examined below.

Defective Drugs By the Numbers

Arguably, $985 million and five are the two most significant numbers in terms of defective drug injuries in Kentucky.

Drug companies spend an average of $985 million to develop a new drug and push it through the FDA’s approval process. So, these companies must sell as much product as possible to recoup this investment and show a tidy profit. Safety disclaimers, such as cancer warnings, scare customers and suppress sales.

On a related money note, user fees and other industry-paid fees provide a significant portion of the FDA’s budget. Some inspectors and bureaucrats do not want to bite the hand that feeds them. So, disciplinary actions are rare, and recalls are almost unheard of.

Once new drugs reach the shelves, manufacturers typically have exclusive rights for five years. After that, other manufacturers can sell cheaper generic alternatives. These alternatives account for over 80 percent of all prescriptions in the United States.

The bottom line is that it’s not enough to sell lots of pills to recoup investment and turn a profit. Manufacturers do not have very much time to sell these pills. As is often the case, in the rush to make money, people get hurt.

Your Claim for Damages

Generally, Lexington mass tort lawyers consolidate dangerous drug claims. This consolidation greatly benefits victims/plaintiffs. 

Typically, judges appoint special masters to oversee consolidated trials, at least for pretrial purposes. These special masters usually have specific experience with a particular substance. So, they know the issues, from both a scientific and legal perspective. Furthermore, consolidated cases allow victims/plaintiffs to pool their resources.

Class action is the largest kind of consolidated case. A few victims speak for everyone in the class. These lawsuits could involve millions of victims. If the cases are not all the same from a factual standpoint, which is often the case, the Multidistrict Litigation rule usually kicks in. If individual claims do not settle, they usually return to their home jurisdictions for trial.

Compensation in a dangerous drug case usually includes money for economic losses, such as medical bills, and noneconomic losses, such as pain and suffering. Additional punitive damages are available as well, in some extreme cases.

Dangerous drugs often cause serious injuries. For a free consultation with an experienced mass tort lawyer in Lexington, contact the Goode Law Office, PLLC. You have a limited amount of time to act.