[Posted 12/08/2015] The U.S. Food and Drug Administration (FDA) first approved Taxotere in 1996 and by 2004, it raked in $1.4 billion each year for Sanofi. The drug is approved for use in treating a variety of cancers. In 2004, the FDA approved the drug despite significant toxicity that could cause leukemia and congestive heart failure, according to the National Cancer Institute.

FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn.

BACKGROUND: Proton pump inhibitors (PPIs) are marketed under various brand and generic drug names as prescription and over-the-counter (OTC) products. They work by reducing the amount of acid in the stomach. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter PPIs are used to treat frequent heartburn.

RECOMMENDATION

• Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve.
• A diagnosis of CDAD should be considered for PPI users with diarrhea that does not improve.
• Advise patients to seek immediate care from a healthcare professional if they experience watery stool that does not go away, abdominal pain, and fever while taking PPIs.
• Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Related Information

• Proton Pump Inhibitors Information
• FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors
• Proton Pump Inhibitors (PPI): Class Labeling Change