Paxil and Pregnancy - A Dangerous Combination
Pregnancies are typically a time when men celebrate with a cigar and women daydream about names – but what about the issue of tackling depression while pregnant? What medication is safe to take and what’s dangerous? What regulations do drug companies face regarding the marketing of these drugs and warnings of use while pregnant?
Before we delve into this, I want to first look at a recent study conducted by Kaiser Permanente Center for Health Research. The group found that more than one in seven women are either depressed in the nine months before pregnancy, during their pregnancy, or in the nine-month period after giving birth.
The study also revealed that women with a history of depression are at a higher risk for postpartum depression – 54 percent of women in the study suffering from postpartum suffered from depression before or during their pregnancy.
This tells us two things: first, that depression is a significant issue for women during pregnancy, and second, that something must be done to treat women suffering from depression in all stages of their pregnancy.
In 2005, GlaxoSmithKline (GSK), the maker of Paxil, released a study that showed an increased risk of heart defects in pregnant women who take the prescription anti-depressant during their first trimester. Both the FDA and GSK were surprised by the results, as they conflicted with previous statements on Paxil and pregnancy.
Most alarming, the study revealed there’s a greater risk associated with Paxil than other anti-depressant medications.
As a result of the study, the FDA required GSK to change the pill’s classification from a C to a D – meaning it should be avoided during pregnancy.
Paxil, first introduced in the U.S. in 1992, was available for more than a decade to fight depression, anxiety and other disorders before GSK issued its warnings. It’s reasonable to assume thousands of mothers used the medication while pregnant--so what is the responsibility of the drug maker?
GSK has a responsibility to consumers to communicate any risks associated with its drugs. That includes conducting due diligence and product testing before submitting any medication to the FDA for approval.
As patients, we are at the mercy of the drug makers and the federal agencies. It can be terrifying. How is an expectant mother at home in Wyoming supposed to know everything about the drugs she’s taking? She can do as much research as she likes, but if the information isn’t available and published, there is no way of knowing.
That’s where private litigation comes in.
Through lawsuits, we have the power to uncover risks and information withheld from the public and improve the way drug makers and the FDA research and release new drugs to the market.
Above all, before a patient begins any drug regime, it’s important to conduct personal research and ask for a second opinion. It’s hard to know or identify the motivating factors behind a prescription, but years of lawsuits against those in the pharmaceutical industry tells us that fraud and misleading practices hide behind many doors. For more information, see www.paxilandbabies.com.

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