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Antidepressants Linked to Stomach Bleeding

Jul 8, 2008 | Parker Waichman Alonso LLP

A Spanish study in the Archives of General Psychiatry is reporting this week that antidepressants taken by millions of people may actually increase a patient’s risk of developing stomach ulcers.  The drugs, which are known as selective serotonin reuptake inhibitors—or SSRIs—include Eli Lilly & Company’s Prozac, Forest Laboratories Inc.’s Celexa and Lexapro, GlaxoSmithKline Plc.’s Paxil, and Pfizer Inc.’s Zoloft.

According to Francisco de Abajo, from the Spanish Agency for Medicines and Healthcare Products, these drugs could trigger gastrointestinal bleeding in one out of every 2,000 patients.  The study found that the risk also applies to Wyeth's innovative pill Effexor, but with Effexor, the risk increases to one in 250 patients when aspirin or pain drugs also are taken.  The researchers found that these medicines interfere with platelets, “a critical part of the body's normal clotting process.”  “The risk … should be considered, de Abajo said, adding that 
"The risk … may be much more important in patients," with a history of ulcers or who regularly use medications such as aspirin and pain pills.  The researchers studied the medical records of 1,321 patients with upper gastrointestinal tract bleeding, and compared them with a healthy group of 10,000 people.  Of those with bleeding, 5.3 percent were taking SSRIs as compared with three percent of the healthy group.  Of those who experienced bleeding, about 1.1 percent were taking Effexor, a different type of antidepressant, compared with 0.3 percent among those without an ulcer.

de Abajo suggests that proton pump inhibitors—drugs that suppress the production of acid in the stomach—such as Prevacid, Prilosec, Nexium, and Protonix, could help minimize the bleeding “for those most vulnerable and should be considered.”  AstraZeneca, Plc., the maker of Nexium and Prilosec, helped fund the Spanish study.

Meanwhile, the Food & Drug Administration (FDA) has investigated a suspected link between cardiac trouble and acid-reflux drugs Prilosec and Nexium.  Also, because both drugs are proton-pump inhibitors, they may be overly effective at stopping stomach acid production, raising pneumonia, bone loss risk, and fracture risk, this by over 40 percent in patients on long-term use.

In a study we reported on in February that was conducted by British researchers on the effect of some antidepressants found that they may only really be truly effective in the most severely depressed of patients.  The study also found that these antidepressant medications actually work no better than placebos in many patients taking them and that the patients fared the same whether on a placebo or on one of the antidepressant medications represented in the study:  Prozac, Effexor, and Paxil.

Meanwhile, there have been warnings that antidepressants might increase suicidal behavior in youth.  U.S. and European regulators sent out a series of public health warnings in 2003 after clinical trials showed the drugs increased the risk of suicidal thoughts and behaviors in children and teens.  In 2004, the FDA issued its strongest warning—a black box—on all antidepressant use in children and teens to draw attention to these medications’ possible risks.