Public release date: 8-Oct-2007
WINSTON-SALEM, N.C. – New research shows that selective serotonin reuptake inhibitors (SSRIs), a group of drugs commonly used to treat depression, may double the risk of gastrointestinal bleeding, according to researchers from Wake Forest University School of Medicine and colleagues. When the drugs are taken with aspirin and other similar pain medications, the risk is more than 600 percent higher.
“Clinicians who prescribe these medications should be aware of the potential risk and may need to consider alternatives,” said Sonal Singh, M.D., senior researcher and an assistant professor of internal medicine. “In addition, regulatory authorities should consider revising existing package inserts to highlight the magnitude of the risk.”
The research was reported online this month in Alimentary Pharmacology & Therapeutics. Emerging evidence has shown that SSRIs may be associated with bleeding of the lining of the digestive tract including the esophagus, stomach or upper part of the small intestine, which together are called the upper gastrointestinal (GI) tract. Upper gastrointestinal bleeding may be potentially serious and require hospitalization for blood transfusions and other treatments.
The researchers pooled data from four studies involving 153,000 patients, which allowed them to detect effects that might not show up in the individual studies. They found patients taking SSRIs were nearly twice as likely to develop upper GI bleeding than patients not taking the drugs. When the patients also took NSAIDs, the risk of upper gastrointestinal bleeding was six times higher than in patients taking neither medication.
In addition to the clinical studies, the researchers analyzed 101 reports on adverse effects submitted to the Canadian Adverse Events Database and the U.S. Food and Drug Administration’s Adverse Event Reporting System. They found that bleeding associated with SSRI use occurred after a median of 25 weeks on the drugs. About 67 percent of those patients were also taking NSAIDs. The adverse reaction was not limited to the elderly, with 38 percent of cases occurring in patients below the age of 60.