In a recent warning, the United States Food and Drug Administration (FDA) announced a concern regarding a connection between a common ingredient in heartburn medicine and a cancer-causing impurity.
About the Impurity
The impurity stems from the inclusion of ranitidine. Ranitidine decreases acid secretion in a person’s stomach by blocking histamine H2 receptors. For this reason, it is commonly prescribed to patients to treat stomach ulcer and heartburn, as well as GERD. Testing found that some batches of this ingredient were contaminated by an impurity referred to as NDMA, which is classified as a probable human carcinogen. If present at certain levels, it is believed that the compound could cause cancer. It is also the same contaminant that was found in Angiotensin II Receptor Blockers (ARBs), blood pressure medications that were recalled due to the contaminant.
The levels of NDMA found in popular heartburn medications like Zantac were low and lower than those found in the recalled ARBs. NDMA is a common contaminant in food, water and the environment, so it is possible that people could have already been exposed to it from these sources. However, because possible exposure through these methods may have occurred, it is important for people to minimize additional concentrations of this contaminant.
What to do if Using Ranitidine
The FDA urges patients to talk about the dangers of ranitidine with their physicians. Alternative medications may alleviate heartburn or other prescriptions for which ranitidine-containing medications are used. The FDA is not currently warning individuals to stop taking the medication altogether, but instead to make an informed decision after discussing the topic with their healthcare provider.
Alternatives to ranitidine that perform the same function include:
- Nizatidine (Axid)
- Famotidine (Pepcid)
- Cimetidine (Tagament)
Additionally, lifestyle modifications like changing your diet, decreasing your consumption of caffeine and alcohol, adjusting your sleep routine and wearing looser clothing can help reduce stomach acid.
Responsibilities of Drug Manufacturers
Drug manufacturers are required to maintain appropriate safety and quality control measures to ensure that their medicines are safe for human consumption. Many manufacturers outsource jobs to other countries, so monitoring the processing of these drugs may be difficult. However, dire consequences can arise when medications contain dangerous contaminants. If a person dies or is injured by a dangerous drug, the manufacturer can potentially be held liable for the resulting damages.
