By Miranda Hitti
 

The FDA and drug company GlaxoSmithKline have strengthened their warning about using the antidepressant drug Paxil during early pregnancy.

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.

The first of those studies prompted an FDA alert and an updated drug label by GlaxoSmithKline, which makes Paxil, in September.

Now, results of the second study have prompted an update. The update includes moving Paxil to a category “D” medication instead of a category “C” for use during pregnancy.

That change reflects a stronger warning about use during early pregnancy. Category “D” drugs have shown risks to fetuses in studies of pregnant women. However in this category, the benefits of the therapy may outweigh the risks.

GlaxoSmithKline, a WebMD sponsor, is sending a letter to doctors with the updated information.

More Heart-Related Birth Defects

In both studies, heart-related birth defects were rare but more common among women who took Paxil in early pregnancy.

“The expectation is that in the general population, the risk of cardiovascular defects is about one per 100 infants,” GlaxoSmithKline spokeswoman Gaile Renegar tells WebMD.

She says the studies show a risk of those heart-related birth defects is one per 50 babies born to women who used Paxil in early pregnancy.

Cause Not Clear

The studies didn’t assign anyone to take Paxil and don’t necessarily prove that Paxil caused those birth defects.

“It’s not clear whether there’s a true causal association,” Renegar says.

Most of the heart defects reported in these studies were holes in the walls of the chambers of the heart (atrial and ventricular septal defects).

“In general,” states the FDA, “these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.”

Studies’ Results

According to the FDA, early results from the two studies showed that women who took Paxil during the first three months of pregnancy were about 1.5 to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population.

In one study, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared with a 1 percent risk in the whole population.

In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared with 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

Weighing Risks and Benefits

The FDA’s news release notes that “the benefits of therapy may outweigh the potential risks to the fetus.”

“In the labeling, I think there’s some important guidance for prescribers as well as patients to take note of,” Renegar says.

“The labeling now advises that patients who become pregnant while they’re taking [Paxil] should certainly be informed of the potential harm to the fetus,” she says.

“Consideration should be given to discontinuing [Paxil] or perhaps switching to another antidepressant, unless the benefit that the mother is experiencing justifies continuing treatment,” Renegar continues.

“For women who intend to become pregnant or are in their first trimester of pregnancy, other treatments and options should be considered first before initiating Paxil. So these are the recommendations that GSK and the FDA support to help put this information in a useful context for physicians as well as women to make well-informed treatment decisions,” she says.

Maker’s Comment

“These studies that are referenced in the new labeling are largely updated analyses from the data that was the justification for the change in September,” Renegar says.

“We have worked very closely with the FDA on the data interpretation, and what the labeling should say, and how to most quickly and effectively get this out into the public,” she says. “It was a collaborative effort.”

By Miranda Hitti, reviewed by Brunilda Nazario, MD

SOURCES: News release, FDA. WebMD Medical News: “Paxil’s Birth Defects Warning Strengthened.” Gaile Renegar, spokeswoman, GlaxoSmithKline. Letter, GlaxoSmithKline: “Dear Healthcare Professional.” Associated Press.

Do I Have a Paxil Lawsuit?

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Source | FDA

The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.  Paxil is approved for the treatment of depression and several other psychiatric disorders.  FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil. 

FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy.  Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients.  In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus.  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.

FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus.  Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy.  Women taking Paxil should not stop taking it without first talking with their physician.

The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

FDA has asked the manufacturer, Glaxo Smith Kline (GSK), 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. However, the benefits of therapy may outweigh the potential risks 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 latest data from the two studies and to change the pregnancy category.

Additional information concerning today’s announcement is available on FDA’s Web site at:
Public Health Advisory: http://www.fda.gov/cder/drug/advisory/paroxetine200512.htm and
CDER Information Sheets: http://www.fda.gov/cder/drug/infopage/paroxetine/default.htm.

Do I have a Paxil Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Paxil lawsuits. We are handling individual litigation nationwide and currently accepting new Paxil birth defect cases in all 50 states.

Free Case Evaluation