Originally published October 4 2005
Drug Company addresses concerns about Paxil's impact on pregnancies
by Mike Adams, the Health Ranger, NaturalNews Editor
GlaxoSmithKline has informed health officials of a possible side effect to their drug Paxil, which has in recent studies been linked to birth defects.
U.S. health officials have issued a warning about possible birth defects in infants born to women who take the antidepressant Paxil during the first trimester of pregnancy.
A study sponsored by GlaxoSmithKline, the drug's maker, suggested that infants born to women taking Paxil were at about double the risk of birth defects compared with women taking other antidepressants.
GlaxoSmithKline, which first alerted the U.S. Food and Drug Administration of the problems around Sept. 6, anticipates labeling changes to the drug, said company spokeswoman Mary Ann Rhyne.
Dr. Mary Jo O'Sullivan, a professor of obstetrics and gynecology at the University of Miami School of Medicine, said the findings do raise some concerns.
"One cannot deny with absolute certainty that there's nothing related to Paxil and an increased risk of malformations, but we dont have a truly controlled population," she said.
Paxil (paroxetine) belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs), which first hit the market in 1988 and are widely used today to treat depression, anxiety and other mood and behavioral disorders in adults as well as children.
GlaxoSmithKline undertook this study because a British pregnancy registry turned up a possible signal for cardiovascular defects in women using bupropion (Wellbutrin) and Paxil.
For this study, the researchers relied on a database affiliated with UnitedHealthcare, a national managed-care plan covering the Northeast, Southeast, Midwest and Western United States.
"I wished I had an explanation," Rhyne said of the discrepancy.
That means that physicians should be talking with patients about potential benefits and potential risks and we recommend that this study be a part of that discussion," Rhyne said.
"The label already has a category C pregnancy caution, which means no adequate, well-controlled studies have been done to determine the effect on the fetus.
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