In July 2006, the FDA issued a warning that selective serotonin reuptake inhibitors (SSRIs), including Lexapro and Zoloft, carried a risk of persistent pulmonary hypertension in children born to mothers taking the drug during pregnancy. Lexapro, manufactured by Forest Laboratories, and Zoloft, manufactured by Pfizer, have also reportedly been linked to heart defects, abdominal wall defects, and craniosynostosis, a birth defect that affects the plates of a baby’s skull. Women taking these medications after twenty weeks of pregnancy reportedly have a higher risk of giving birth to a child with a birth defect
SSRIs have become the staple of the antidepressant industry.
This week, a new SSRI medication co-marketed by the Japanese company Takeda and the Danish manufacturer Lundbeck received approval from the European Medicines Agency following approval for use in the U.S. a month earlier. The FDA, in a news release, announced that Brintellix had been approved to treat adult major depressive disorders.
Despite lawsuits over Lexapro and Zoloft, SSRIs have become the staple of the antidepressant industry. Brintellix, generic chemical name vortioxetine, is being released at a time when the Lundbeck’s popular Celexa / Cipramil (generic: citalopram) comes to the end of its patent protection. Brintellix will be introduced to the U.S. as a prescription medication and, like other SSRIs, will include a black box label warning that it may induce suicidal thoughts and behavior in patients between the ages of 18 and 24.
SSRIs have faced a number of lawsuits over allegations that they cause birth defects in children whose mothers were taking the drug. These birth defects include:
- Heart defects
- Coarctation of the aorta
- Tetralogy of fallot (TOF)
- Transposition of the great arteries (TGA)
- Spina bifida
- Limb defects
- Abdominal wall defects (omphalocele)
- Skull defects (craniosynostosis)
- Club foot
Should patients be worried by the approval of a new SSRI? EMA and FDA approval is, of course, reliant on data collected from trial studies, and in Brintellix’s case, more than 4,000 patients with depression were given the drug in 12 short-term (6 to 8 weeks) placebo-controlled studies, with 9 of the 12 studies’ data suggesting that Brintellix was able to improve the effects of depression compared to the placebo. An earlier study conducted on rats also suggested that the drug may improve some facets of memory. According to the LA Times, a clinical trial also found that subjects taking the antidepressant venlafaxine (marketed as Effexor) also suffered more sexual dysfunction than those taking vortioxetine.
The FDA has produced a guide, Antidepressant Use in Children, Adolescents, and Adults, with more information on the correct use of these medications. Brintellix is expected to hit the European market as early as 2014.