Earlier this week the US Food and Drug Administration (FDA) requested that manufacturers pull all prescription and over-the-counter ranitidine drugs, known by the brand name Zantac, from the market immediately. Zantac was given US approval in the early 1980s.
The FDA has determined that levels of N-nitrosodimethylamine (NDMA) in the heartburn medications increase over time and when stored at higher-than-normal temperatures, pose a risk to public health.
According to the FDA's announcement, letters are now being sent to all manufacturers of ranitidine requesting that they withdraw products from the market, and consumers are advised to stop taking any ranitidine tablets or liquid medications they currently have. As a result of this immediate market withdrawal request, writes the FDA, ranitidine products will not be available for new or existing prescriptions or over-the-counter (OTC) use in the U.S.
Sanofi, one of the companies that produces the Zantac brand, stopped doing so in October. It said in a statement that “We take this issue seriously and continue to work closely with the F.D.A. to evaluate any potential safety risks associated with Zantac.”
Ranitidine was launched in the UK in 1995 as an OTC product. At the time the recommended dosage of the product was one tablet, although if symptoms persisted for more than one hour another tablet could be taken. Consumers were told, "the maximum recommended daily dose is four tablets."
The British drug regulator, the MHRA, is not following in the footsteps of their American counterparts. In October last year, they stated, "the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant N-nitrosodimethylamine."
Los Angeles trial lawyers, Baum Hedlund Aristei & Goldman, PC, who are in the process of filing lawsuits, state on their website, "Mounting evidence allegedly shows that Sanofi and Boehringer Ingelheim, the big pharma companies that make Zantac (ranitidine hydrochloride), concealed the Zantac cancer link from millions of people who took the drug for heartburn, gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), sour stomach, Barrett’s esophagus, acid reflux, and other issues. This deception came as the companies made unprecedented profits from Zantac, the first drug to generate $1 billion in sales."
Baum, Hedlund, Aristei & Goldman attorney R. Brent Wisner discusses the latest revelations surrounding the popular drug Zantac (ranitidine). How did the FDA find out about the link between Zantac and cancer? What do Zantac and rocket fuel have in common? Is Zantac causing a cancer epidemic? Wisner answers your Zantac questions in this short video.
If you, or anyone you know, developed cancer after taking Zantac please contact Baum Hedlund here.
Bob Fiddaman
No comments: