The British equivalent of the U.S. Food and Drug Administration (FDA) has ordered pharmaceutical companies that market selective serotonin reuptake inhibitors (SSRIs) in the United Kingdom to add a warning to their labeling regarding the risk of suicide in people who take these medications. In making this decision, the U.K.’s Medicines Control Agency (MCA) acknowledged that "a number of epidemiological studies and analyses of clinical trial data have failed to find an association between [SSRIs] and increased suicidal behavior."

The new suicide warning is the result of "an extensive review" of the five SSRIs marketed in the U.K., citalopram, fluvoxamine, fluoxetine, paroxetine, and sertraline, by the MCA’s Committee on Safety of Medicines (CSM).

The CSM reviewed adverse drug reports (known as "Yellow Cards" in the U.K.), published literature, and current product information in an effort to verify the presence of an adverse-effects profile common to all of the SSRIs.

"Whilst the reporting rate of suicidal behavior for all SSRIs through the Yellow Card scheme has been low in recent years," the CSM determined, "there continue to be anecdotal case reports of suicidal behavior associated with fluoxetine."

The labeling of the five SSRIs will be required to include the words: "Occasionally, thoughts of suicide or self-harm may occur or may increase in the first few weeks of treatment with [insert drug name], until the antidepressant effects become apparent. Tell your doctor immediately if you have any distressing thoughts or experiences."

In addition, the CSM documented more than 1,600 reports of significant withdrawal reactions associated with this class of antidepressants. As a result, the MCA will also ask drug manufacturers to revise labeling of SSRIs to include the wording: "Gradual tapering of dose should be considered when SSRIs are discontinued."

The CSM noted that it is the responsibility of the prescribing physician, who knows the patient and his or her medical history, to decide on what the most appropriate course of treatment should be and advised that any "patients thought to be at risk should be carefully monitored."

While the CSM said it will continue to closely monitor the issue, a spokesperson for the U.S. FDA said the agency would have no comment on the new British warnings, noting only that "the Psychopharmacological Drugs Advisory Committee has reviewed the data pertinent to this issue in the past and has advised the FDA that no additional language is warranted at this time."