Paxil Andidepressant Pregancy Lawsuit,Lawyers Alert: Injury Attorneys, paroxetine, heart defects

FDA Strengthens Warning on Paxil
Paxil Antidepressant Drug News Alerts, Lawsuits and Lawyer Updates

Paxil Warnings On December 8, 2005, the U.S. Food and Drug Administration issued a warning against the use of the antidepressant Paxil by pregnant women. The warning was based on preliminary results from two studies that suggested the GlaxoSmithKline drug may raise the risk of birth defects.

Paxil and paroxetine, its generic version, relieves depression and other psychiatric problems. However, results from one study showed that women who took Paxil in the first three months of their pregnancies had a 2 percent chance of having a baby with a heart defect, compared to a 1 percent chance in the general population. Most of the defects were holes in the chambers of the heart. Some required surgical repair, while others were mild enough to resolve without treatment.

The second study showed a 1.5 percent chance of developing defects with Paxil, compared to a 1 percent chance in expectant mothers taking other types of antidepressants.

The FDA has asked Glaxo to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the results from the second study, and to change the pregnancy category.

In a letter to physicians, Glaxo stated that �It is not clear if the findings from these studies represent a true causal association" between Paxil and birth defects. However, the company stated that it felt it was important that doctors be alerted.

Women currently taking Paxil are being told not to discontinue treatment without first talking to their doctors. The FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.

According to Glaxo, about 25 percent of U.S. prescriptions of paroxetine are for women of child-bearing age.

Paxil was instructed by the FDA in October 2004 to place a Black Box warning on Paxil due to concern about its use by children or adolescents. In addition to suicide and self-inflicted injuries by individuals under the age of 18, additional side-effects from Paxil include the following:

Nausea
Dry Mouth
Decreased Appetite
Sexual Side Effects
Diarrhea
Constipation
Asthenia
Insomnia
Sleepiness
Infection
Sweating
Tremor
Abnormal Vision

PAXIL LAWYERS / ATTORNEYS
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Paxil Antidepressant Drug NEWS & LAWYER UPDATES

Paxil: Stronger Birth Defects Warning by Paxil and FDA
Fox News - December 9, 2005
... The warning is based on early results from two studies. The studies showed a higher rate of heart-related birth defects in babies born to women who took Paxil during early pregnancy than in babies of women in the general population or women who took other antidepressants.

FDA: Paxil Linked to Birth Defects
CNN / Medpage - December 8, 2005
... The FDA warned doctors today that preliminary results implicate the antidepressant Paxil (paroxetine) with an increased risk of birth defects. The FDA informed doctors that results of new studies suggest that Paxil use during the first trimester increases the risk of congenital heart defects in the developing fetus.

FDA Advising of Risk of Birth Defects with Paxil
FDA - December 8, 2005
... Federal health investigators are looking into reports that some men who used Viagra may have suffered a new and very serious side effect -- blindness. Twenty-three million men worldwide have used Viagra. A very small number of them are going blind after taking normal doses. And CBS News has learned from the FDA that it is urgently meeting about it with experts and Pfizer.

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