Selective Serotonin Inhibitors Recall

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Potentially Life-Threatening Serotonin Syndrome with Combined Use of SSRIs or SNRIs and Triptan Medications

There is the potential for life-threatening serotonin syndrome (a syndrome of changes in mental status, autonomic instability, neuromuscular abnormalities, and gastrointestinal symptoms) in patients taking 5-hydroxytryptamine receptor agonists (triptans) and selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephrine reuptake inhibitors (SNRIs) concomitantly (see drug names at the bottom of this sheet). This information is based on reports of serotonin syndrome occurring in patients treated with triptans and SSRIs/SNRIs, and the biological plausibility of such a reaction in persons receiving two serotonergic medications. The FDA recommends that patients treated concomitantly with a triptan and an SSRI/SNRI be informed of the possibility of serotonin syndrome (which may be more likely to occur when starting or increasing the dose of an SSRI, SNRI, or triptan) and be carefully followed.

Debate Resumes on the Safety Of Depression’s Wonder Drugs

Warnings by drug regulators about the safety of Paxil, one of the world’s most prescribed antidepressants, are reopening seemingly settled questions about a whole class of drugs that also includes Prozac and Zoloft.

Doctors are just beginning to react to the finding — reported first by British drug authorities in June and then endorsed the next week by the Food and Drug Administration — that unpublished studies about Paxil show that it carries a substantial risk of prompting teenagers and children to consider suicide.

Because the studies also found that Paxil was no more effective than a placebo in treating young people’s depression, the regulators recommended that doctors write no new Paxil prescriptions for patients under 18. Experts say that the suicide risk is highest in the first few weeks young patients are on the drug.

The concern that Paxil and drugs like it could cause suicide had been weighed, and rejected, by regulators a dozen years ago, amid early concerns about the group of antidepressants known as selective serotonin reuptake inhibitors, or S.S.R.I.’s. In the meantime, millions of people have taken the drugs, and many experts say that they have prevented far more suicides by teenagers and children than any reading of the new findings suggests they could have caused.

Almost no one suggests that Prozac, Zoloft, Paxil and their cousins are not safe for the vast majority of adults, although studies have shown them to be only modestly effective.

Still, the warnings have the early critics saying they feel vindicated. Plaintiffs’ lawyers who have uncovered evidence that they say shows drug makers withheld evidence of the S.S.R.I.’s suicide risk from regulators say the warnings give fresh urgency to their claims.

FDA 2006 Data Summary on SSRI Study

A retrospective case-control study published on February 9, 2006, in the New England Journal of Medicine assessed the risk for persistent pulmonary hypertension of the newborn (PPHN) following exposure to SSRIs during pregnancy. 377 women whose infants were born with PPHN and 836 women whose infants were healthy were enrolled in the study in four United States metropolitan areas between 1998 and 2003. The study showed that infants born to mothers who took SSRIs after the completion of the 20th week of gestation were 6 times more likely to have PPHN than infants who were not exposed to antidepressants during pregnancy. 14 infants with PPHN and 6 healthy control infants had been exposed to an SSRI after the 20th week of gestation. There were too few cases of PPHN with each individual SSRI to compare risks for PPHN with individual SSRIs. The study did not find an association between exposure to SSRIs during the first 20 weeks of gestation and PPHN.

Exposure to non-SSRI antidepressants did not appear to be associated with an increased risk of PPHN, although the number of infants with exposure to non-SSRI antidepressants was too small to permit a reliable risk estimate or comparison with the risk observed for SSRIs.

In weighing the risks and benefits of treatment with SSRIs and other antidepressants during pregnancy for individual patients, physicians should also note the recent publication of a prospective longitudinal study of 201 pregnant women with a history of major depression in the February 1, 2006, issue of JAMA. In this study, women who discontinued antidepressant medication during pregnancy had a higher risk of relapse of major depression during pregnancy (68%) than women who maintained antidepressant medication throughout pregnancy (26%).

Increased Risk of Neonatal Persistent Pulmonary Hypertension FDA

Alert June 2006

A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births. Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information. The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.

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