As far back as 2005—and possibly even further—doctors have been aware of the potential link between SSRI antidepressant drugs and birth defects. As many as one in four women suffers from some level of depression during their pregnancy. Many are prescribed selective serotonin reuptake inhibitors (SSRIs) by their doctor (such as Zoloft and Paxil). Yet studies, regulatory actions and lawsuits from women, have pointed to potentially serious side effects when SSRI antidepressants are taken during a woman’s pregnancy. The most common types of birth defects seen in babies whose mothers took SSRI drugs during pregnancy are lung problems, skull defects, club feet, cleft lip, cleft palate, spina bifida, transposition of arteries, holes in the heart and abdominal defects.
Environmental Factors to Blame?
Those who believe the SSRI drugs are not responsible for these birth defects point to environmental factors such as smoking, consumption of alcohol, and the high rates of hypertension and diabetes as more likely causes of the birth defects than SSRIs. Genetic factors, or the depression itself, may also be the link to birth defects. The FDA has given women few concrete details to go on.
FDA Waffles Regarding Risks of SSRIs to Pregnant Women
In December 2005, the FDA issued a warning to pregnant women that Paxil, taken during the first trimester, could increase the risk of congenital heart defects in babies. The manufacturers of Paxil were then required to modify the warning label so it advised women of the risk. In 2006, the FDA noted that the dangers of depression should be balanced with the risk of newborn birth defects. Then in 2011, the FDA cast doubt regarding a link between SSRI drugs and a birth defect which affects the lungs of newborns. The failure to warn on SSRI drugs has resulted in hundreds of lawsuits against GlaxoSmithKline, the manufacturer of Paxil, and Pfizer, the manufacturer of Zoloft.
Prozac on the Market Nearly Three Decades
In 1988, Prozac hit the U.S. market—the first SSRI. Seventeen years later, in 2005, SSRIs were the most prescribed drug in the nation. SSRI drugs work by altering the levels of serotonin in the brain—a mood-enhancing chemical. Some of the more common side effects of SSRIs include repressed libido, insomnia, headaches, fatigue, weight loss, apathy and pupil dilation. New studies not only link SSRI drugs to specific newborn birth defects, but to an increased risk of autism spectrum disorder.
Depression in the U.S. an Epidemic?
Nearly one in ten Americans are currently taking an antidepressant. The numbers are much higher for women, at one in four women in their 40’s and 50’s. Because doctors are much more likely to prescribe antidepressants to women, some 13 percent of pregnant women are taking the drugs. Some doctors believe the possible risks of birth defects have to be weighed against the possibility of expectant mothers with depression or anxiety hurting themselves or placing their baby at risk.
Study Links SSRIs to Autism
A 2015 study published in JAMA Pediatrics concluded mothers who took SSRI antidepressants while pregnant were a staggering 87 percent more likely to have a baby born with autism. When taken during the second and third trimester, the risk increases by about 200 percent, and women taking drugs such as Zoloft, Prozac or Paxil have double the risk of having a baby who is diagnosed with autism by age 7. This particular study was based on a large group of almost 150,000.
Other Issues Associated with SSRIs
Serotonin Syndrome can occur when a patient accumulates too much serotonin in the brain—from an overdose, or from taking a combination of medications which boost serotonin levels beyond what the brain can compensate for. In other cases, patients who stopped taking an SSRI have suffered balance problems, gastrointestinal and flu-like symptoms, sensory disturbances, sleep disturbances, anxiety, agitation, aggressive behaviors, crying spells and irritability—serious symptoms of withdrawal.
Doctors Must Warn Pregnant Women of the Risks of SSRI Drugs
While many medical and legal professionals believe drug companies who manufacture SSRIs must be held accountable for failure to warn, perhaps doctors need to bear some of the responsibility as well. Most doctors are well-aware of the link between SSRIs and birth defects, and concerns should be properly relayed to expectant mothers. There are other types of antidepressants, such as Wellbutrin, which do not work in the same way as SSRIs and have not been linked to birth defects. In 2010, GlaxoSmithKline settled more than 800 cases of Paxil birth defects for more than $1 billion. Hundreds of lawsuits against other SSRI manufacturers remain pending.
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