GlaxoSmithKline is recalling Zantac as a precautionary measure after the FDA found levels of probable cancer-causing impurity in the drug. This is significant news for pregnant women since heartburn is one of the most common types of pain that pregnant women deal with.
Zantac is the latest drug in which cancer-causing impurities have been found. Regulators have been recalling some blood pressure and heart failure medicines since last year, according to CBC News. GlaxoSmithKline is recalling four prescription-only Zantac medicines: a syrup, an injection and tablets of 150 and 300 milligram (mg) dosages. Over-the-counter 75 mg dosage Zantac products are produced by a different company and are not affected by the recall.
Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach. The prescription versions are used to reduce stomach acid to prevent and treat conditions, such as heartburn, ulcers of the stomach and intestines, and gastroesophageal reflux disease or GERD, according to Health Canada. In pregnant women, the fetus can create upward pressure as it grows, pushing on the abdomen, causing major heartburn.
And as the baby grows, the fetus can create upward pressure, pushing on the abdomen. “The food goes north rather than south,” said Dr. Joel E. Richter, the director of the division of gastroenterology and nutrition at the University of South Florida who has studied the effects of heartburn medications taken during pregnancy.
Certain dietary changes such as avoiding spicy, acidic or fatty foods; limiting caffeine and eating smaller, more frequent meals can help. It’s also best to remain upright for a couple of hours after eating. If those changes do not make a difference, Dr. Richter said, the first line of defense during pregnancy is typically to use sucralfate (Carafate), a prescription ulcer medication that is sometimes used for treating reflux disease; or antacids that do not contain aspirin (such as Tums, Mylanta or Gaviscon).
If still these measures are not enough, doctors typically advise pregnant women to take histamine blockers like ranitidine to reduce the amount of acid in the stomach. With the recent recalls, pregnant women can opt for a different class of drugs called proton pump inhibitors, which inhibit the secretion of stomach acid, such as Prilosec (omeprazole).
NDMA is classified as a probable human carcinogen, which means long-term exposure could increase the risk of cancer, according to regulators. The U.S. regulator has asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency. The impurity was believed to have been introduced by changes in the manufacturing process. Ranitidine works by blocking the action of acid-producing cells in the stomach.