In 1979 the United States Food and Drug Administration (FDA) introduced drug classification categories of fetal risks due to pharmaceuticals. The manufacturer of Paxil, GlaxoSmithKline, was asked by the FDA in 2005 to reclassify Paxil from Pregnancy Class C to Pregnancy Class D. With the reclassification many women are beginning to think if taking Paxil during pregnancy is really worth it.

Before the FDA asked GSK to reclassify Paxil it was in pregnancy category class C.  According to the FDA a pregnancy category class C drug is defined as: “Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."

After the FDA request Paxil is now pregnancy category class D. The FDA officially defines a pregnancy category class D drug as: “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”

A new question arises with the class reclassification of Paxil which is if it will affect how the drug is prescribed to pregnant women. Taking into consideration that Paxil is now classified as a potential risk to a developing fetus many women may stray from taking the drug as the potential risks may outweigh any positive effects the drug may have. The Potential risks of taking Paxil during the last trimester of pregnancy have been known to include: general irritability due to withdrawal from the medication, seizures or persistent pulmonary hypertension (PPHN), a serious and life-threatening lung condition. However, an instance in where Paxil may be prescribed to a pregnant woman is if the patient has already taken other antidepressants with no positive response.

The FDA’s request to GSK to reclassify Paxil from pregnancy category class C to pregnancy category D may have caused many current users of Paxil to rethink using the drug.  This reclassification may also change how the drug is prescribed to women who are pregnant or are looking to become pregnant because of possible Paxil birth defects. If you are looking to take Paxil for your signs and symptoms of depression, consult with your doctor first.

Around one in every 1,000 babies born in the United States have clubfoot.  A comparatively common birth defect, one or both feet can be affected and ranges from mild to severe.   Medical experts call this “Congenital Talipes Equinovarus” and is often seen by the foot turning inward and downward at birth. People believe its cause is unknown but there are studies that say taking antidepressants during pregnancy could lead to birth defects.  Some studies even point a link between Paxil and macrocephaly.

Clubfoot does not cause any discomfort or pain and a baby with this malformation would continue developing normally until he or she starts to stand and walk.  When the deformity is not treated, he or she could walk on the sides of his or her feet.  This could be further complicated by infection on the part used for walking and over time, it could lead to arthritis.

This malformation could be treated through non-surgical means. Usually, it involves manipulation, casting, splinting, and taping.  Its major goal is to make the foot appear normal and restore its function.  An orthopedic specialist is usually the person to address this.  It is ideal that clubfoot be treated as soon as it is detected after birth since this is when the newborn's bones is easiest to reshape.

Nowadays, many experts believe that genetic and environmental factors contribute to clubfoot.  Environmental factors include smoking, infection and drug use.  Paxil is an antidepressant classified under Selective Serotonin Reuptake Inhibitor (SSRI) that doctors prescribe even to pregnant women to treat mood disorders and depression. Classified by the FDA as a drug that could cause potential harm to the developing fetus, Paxil is one of the drugs being looked at closely because it allegedly causes an array of birth defects among newborns.

To mothers of children who have clubfoot as a result of taking Paxil, there is a legal option that you can take.  Its manufacturer has an obligation to answer the apparent flaws in its product.