The study compared 377 women whose infants had PPHN with 836 whose infants did not have the condition. Overall, 14 of the infants with PPHN had been exposed to an SSRI after the 20th week of pregnancy, compared to 6 of the infants in the control group.
That means that PPHN "occurred about six times more frequently in women taking SSRIs," said Christina Chambers, lead author of the study and assistant professor of pediatrics at the University of California, San Diego.
The results of the study prompted FDA officials to hold a news conference. "This appears to be a very well-conducted study and we find the results to be very concerning," said Dr Sandra Kweder, deputy director of the office of new drugs at the FDA.
Two months after the results of the PPHN studies came to light, on April 7, 2006, the BBC reported that a Canadian study, from the University of Ottawa, of almost 5,000 mothers, found those who used SSRIs were more likely to have premature and low birth weight babies.
The researchers compared babies born to 972 women taking SSRIs with babies born to mothers who did not take antidepressants and found women using the drugs were twice as likely to have a stillbirth, and nearly twice as likely to have baby with a low birth weight as well.
Almost 20% of women who used SSRIs gave birth prematurely, compared to 12% of mothers who did not use the drugs. Infants born to women using SSRIs were also found to be more likely to have seizures.
In July 2006, the FDA instructed the drug companies to revise the labels on SSRIs to include information about the life-threatening lung problem PPH.
In addition to all the side effects found to be associated with SSRIs, studies have shown the drugs to be ineffective. In fact, in 1998, a meta-analysis of published clinical trials also indicated that 75% of the response to antidepressants was duplicated by placebo (Kirsch & Sapirstein, 1998).
Four years later, an analysis of the efficacy data submitted to the FDA for approval of the 6 most widely prescribed antidepressants approved between 1987 and 1999, determined that approximately 80% of the response to medication was duplicated in placebo control groups, according to the Emperor's New Drugs study, Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions, published in the journal Prevention & Treatment, Volume 5, Article 23 (2002).
"Improvement at the highest doses of medication," the article said, "was not different from improvement at the lowest doses."
In an article responding to comments on the Emperor's New Drugs study, Kirsch et al stated that "there is now unanimous agreement among commentators that the mean difference between response to antidepressant drugs and response to inert placebo is very small."
"It is so small that," they noted, "despite sample sizes involving hundreds of participants, 57% of the trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo."
The authors went on to say that the small difference between the drug response and the placebo response has been a "dirty little secret" known to researchers who conduct clinical trials, FDA reviewers, and a small group of critics who analyzed the published data, but until now it was not known to the general public, depressed patients, or even their physicians.
In addition to depression, SSRIs are now being prescribed for a wide variety of conditions including, generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder.
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