(RxWiki News) A common acid reflux medication has been in the news for containing low levels of a possible cancer-causing impurity. Here's what you need to know.
Last month, the US Food and Drug Administration (FDA) issued a statement about low levels of a possible cancer-causing impurity found in medications found under the names ranitidine (active ingredient) and Zantac (brand). These drugs are available over the counter and via prescription.
Below are the answers to some common questions about the warnings surrounding ranitidine.
Why have some ranitidine products been recalled?
A possible cancer-causing impurity (a nitrosamine impurity) has been detected in some ranitidine products. This impurity is called N-nitrosodimethylamine (NDMA).
According to the FDA, two companies have issued a voluntary recall of ranitidine:
- Sandoz issued a recall because it was able to confirm unacceptable levels of NDMA.
- Apotex issued a recall out of caution.
How dangerous is NDMA?
NDMA is commonly found in water and some foods. However, the FDA noted that the amount of NDMA found in some ranitidine medications is a little more than the amount you may find in common foods. Health officials have classified ranitidine as a "probable human carcinogen," meaning that it may cause cancer.
Have all ranitidine medicines been recalled?
Not all ranitidine products are being recalled.
How do I know if the ranitidine that I take or have at home has been recalled?
For the most up-to-date information, refer to the FDA’s ranitidine updates page.
Should I stop taking ranitidine?
At the time of publication, the FDA did not have enough evidence to recommend whether to stop taking ranitidine. However, the agency said it was continuing to perform tests to determine the risk.
The FDA recommended that consumers who would like to stop taking prescription ranitidine talk to their doctors about other treatment options.
Other over-the-counter medications are approved to treat the same conditions as ranitidine. Those taking an over-the-counter version can use another over-the-counter medication that is approved for their condition. Ask your local pharmacist about other treatment options.
Which ranitidine alternatives do not contain NDMA?
Below are some medications that may be alternatives to ranitidine. Before you start taking a new medication, seek advice from your local pharmacist.
Medications that are in the same class as ranitidine:
Other medications that can treat acid reflux but belong to a different class of medications:
What else should I know?
The FDA recommended that consumers report any side effects tied to any medication, including ranitidine, to the FDA’s MedWatch program.
Speak with your health care provider if you have any questions.
Written by Anyssa Garza, PharmD, BCMAS