FDA Issues Advisories on Depression Medicines

In separate advisories, the FDA warned July 19 that it may be dangerous to take certain medications for migraine headache and depression simultaneously and that decision-making in treating pregnant women who have depression is becoming increasingly complex.

"A life-threatening condition called serotonin syndrome may occur" when patients take so-called triptans to treat migraine headaches at the same time as they take selective serotonin reuptake inhibitors, known as SSRIs, or selective serotonin/norepinephrine reuptake inhibitors, known as SNRIs, said the FDA in a public health advisory.

Serotonin syndrome, caused by an excess of the neurotransmitter serotonin, is associated with symptoms such as restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased temperature, overactive reflexes, nausea, vomiting and diarrhea, said the FDA advisory.

"Serotonin syndrome may be more likely to occur when starting or increasing the dose of a triptan, SSRI or SNRI," said the FDA document. It advised physicians to

In a second July 19 public health advisory, the FDA cited two research reports that clarify challenges involved in treating pregnant women who have depression.

The abstract for one of the reports, "Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment," says 68 percent of women in the study who discontinued their antidepressants had a relapse of major depression. By comparison, 26 percent of the women who continued their antidepressants had a relapse. The article appeared in the Feb. 1 issue of the Journal of the American Medical Association.

The abstract for the second report, "Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn," supports the association between persistent pulmonary hypertension of the newborn, or PPHN, in infants and the use of SSRIs by the infants' mothers after the 20th week of pregnancy. The article appeared in the Feb. 9 issue of The New England Journal of Medicine.

The FDA advised, "The uncommon potential risk to the newborn of PPHN has not been confirmed by additional studies. … Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant without first consulting their physician. The decision to continue medication or not should be made only after there has been careful consideration of the potential benefits and risks of the medication for each individual pregnant patient."