FDA Takes Action on Antidepressants and Migraine Drugs

Associated Press
July 20, 2006

The Food and Drug Administration asked Wednesday that manufacturers of Prozac and similar antidepressants change their labels to include information about an uncommon but life-threatening lung problem that can affect babies born to mothers who take the drugs during pregnancy

The agency also issued an alert about the possible risk of combining antidepressant medications with common migraine  drugs called triptans, saying a life-threatening condition called serotonin syndrome might occur when the drugs are combined.

The agency said it was seeking more information on both risks.

Babies with the lung disorder, called persistent pulmonary hypertension, have high pressure in the blood vessels of their lungs and are not able to get enough oxygen into their bloodstreams. One or two babies per 1,000 develop the disorder shortly after birth. But a study published Feb. 9 in The New England Journal of Medicine found that infants whose mothers took antidepressants in the second half of pregnancy had six times the expected risk of it.

That report was issued just days after The Journal of the American Medical Association published a study illustrating the potential risk of depression relapse in women who stopped taking prescribed antidepressants during pregnancy. Taken together, the two studies worried many women because they implied that there were risks during pregnancy in both continuing on the medications and not.

The drugs, also called selective serotonin reuptake inhibitors, or S.S.R.I.'s, include Prozac, Zoloft, Paxil and Lexapro. The F.D.A. said Wednesday that it would issue further updates on the drugs' labels as more information became available.

"It is important to emphasize that the F.D.A. recommends that women who are expecting and currently taking antidepressants should not discontinue use without first talking with a doctor," said Susan Bro, a spokeswoman for the agency.

 

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FDA: Mixing Migraine, Depression Meds Risky

Associated Press
July 19, 2006

People taking migraine drugs together with some antidepressants are at risk of a life-threatening condition, health officials warned Wednesday.

Serotonin syndrome can occur when migraine headache drugs called triptans are taken with antidepressants known as selective serotonin/norepinephrine reuptake inhibitors, or SSRIs and SNRIs. The syndrome occurs when the body has too much of the nervous system chemical serotonin.

Patients taking the drug combination can experience restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea, the FDA said.

Commonly prescribed SSRIs include Prozac, Zoloft, Paxil and Lexapro. SNRIs include Cymbalta and Effexor. Triptans include Amerge, Axert, Imitrex and Zomig.

The FDA asked the manufacturers of all three types of drugs to update their prescribing information to warn of the potential risk of serotonin syndrome.

Patients taking a triptan with either an SSRI or SNRI should talk to a doctor before stopping their medications, the FDA said.

 

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