The Zantac Halt Has Escalated To A Worldwide Recall
- Story Highlights:
Back in September, the FDA discovered that the drug Zantac and its generic counterparts, called ranitidine, included trace amounts of the chemical NDMA. This chemical is found naturally in smoked and cured foods, but despite the natural source it’s considered a likely carcinogen. That means it can cause cancer in humans. Zantac’s producer halted production when it got the news, and after several days it issued a recall of its prescription-strength drugs.
Where It Began
The look at Zantac began when an online pharmacy called Valisure tested Zantac and discovered high amounts of NDMA. After that, the FDA conducted its own test using a different method and confirmed the NDMA, although their test showed an amount that was only slightly higher than what you would find in grilled or smoked meats. That was when production halted, and although the FDA didn’t ask for a recall that’s exactly what the drug’s manufacturer did. They have asked doctors to stop prescribing it and pharmacies to stop supplying prescription-strength ranitidine.
What The Problem Is
Ranitidine isn’t the source of the problem, at least not directly. Instead, the problem is the manufacturing process used to create the drug. While companies are careful to purify the medication formulas they produce, they don’t always get everything and it can be hard to find certain chemicals unless you already know what you’re looking for. The manufacturing process for making ranitidine and several other medications has changed recently, and as it turns out this new process creates small amounts of NDMA that have until now gone unnoticed.
How It’s Expanding
Other companies are also taking action to stop production of the drug. Walmart, CVS, and other major pharmacies have stopped selling over-the-counter drugs that include ranitidine even though they aren’t part of the recall, and authorities in Europe, Canada, and Hong Kong have also stepped in and ordered drug recalls in their areas. Because the problem seems to be with the manufacturing process, there could be very different amounts of NDMA in ranitidine drugs depending on the product and the manufacturer, and so the FDA has asked for samples from every company that makes the drug.
What Consumers Can Do
NDMA is classified as a “probable carcinogen.” This means that lab testing has connected it to cancer, but there are no real long-term studies connecting NDMA to specific cancer cases. Ultimately, this means it’s unlikely that someone who regularly takes prescription-strength ranitidine drugs will be able to prove that the drug was directly responsible for any cancer they happen to suffer from. Fortunately, drug manufacturers and pharmacies are being very active by pulling ranitidine products off shelves, and other heartburn medications offer alternatives for the people who need them.
The Zantac recall is a good example of why it’s important to keep track of drug news even if the only drugs you take are tried, tested, and available over the counter. Manufacturing impurities can make a drug dangerous to take even if the active ingredient is safe and well understood, so it never hurts to keep an ear to the ground. And if a drug does end up causing you real harm, be sure to contact a good personal injury lawyer in your area to find out what your options are.