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Dangerous Drugs/Product Recalls

10/7/2009
John Cooper
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Paxil, Similar Antidepressants Linked to Birth Defects

Reading the pregnancy warnings section of the Paxil drug label is a troubling experience. For starters, the antidepressant known generically as paroxetine produces heart defects in as many of 2 percent of babies whose mothers take the drug during the first trimester. Many women taking the drug to relieve depression, anxiety, obsessive-compulsive disorder or posttraumatic stress disorder may not even know they are pregnant during those first three months.

Women who take Paxil during the third trimester of pregnancy put their newborns at risk for--quoting the drug's U.S. Food and Drug Administration-approved labeling--"respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying."

As if these risks weren't severe enough, new evidence shows that Paxil use during pregnancy puts babies at risk for a broad range of physical defects and neonatal illnesses. Danish researchers looked at the health of infants born to women who took Paxil and similar antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, and found that the babies had twice the risk for being delivered prematurely. Infants exposed to SSRIs in the womb also had greater risks for having underdeveloped heads and having health problems that required admission to the intensive care unit.

In the dry language of academia, the Danish researchers wrote in the October Archives of Pediatric & Adolescent Medicine that their study "justifies increased awareness to the possible effects of intrauterine exposure to antidepressants."

Significantly, the latest research shows that all SSRIs put developing infants at risk for birth defects and serious illnesses after birth. SSRIs include Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine) and Zoloft (sertraline).

Pregnant women with mental health problems should certainly continue treatment, and nothing written here puts blame on women for taking antidepressants. The responsibility for choosing the safest medications for pregnant women and developing infants rests on doctors and pharmacists. Drug makers and regulators like the FDA have the ultimate responsibilities for keeping dangerous drugs out the hands of patients to which they can do the most harm. Certainly, SSRIs--and particularly Paxil--are poor choices for pregnant women.


About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and we have experience handling dangerous drugs and prescription drug errors. Check out our dangerous drug information page to learn more about side effects and recalls. Our primary office in based in Virginia Beach, Virginia (VA) and we have another office in Elizabeth City, North Carolina (NC). Our lawyers hold licenses in NC, SC, WV, KY and DC. We are ready to talk to you by phone right now—we provide free initial confidential injury case consultations, so call us toll free at 1-800-752-0042. Our injury attorneys also host an extensive injury law video library on Youtube . Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.



EJL



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