In the early years of the 90's GlaxoSmithKline (GSK) marketed the antidepressant drug Paxil. Annually, this global healthcare company would profit around $1 billion from the sales of this drug alone as this drug is among the bestselling drugs in the US. Unfortunately, at recent time, the stalwart esteem of the maker and the drug is weakened by the many controversies particularly the aggravated risk of congenital defects linked with the use of drug during pregnancy.

Generically known as paroxetine hydrochloride, Paxil was once given a Pregnancy Category C by the Food and Drug Administration (FDA). Yet, the FDA quickly changed its classification to a Category D after data testifying positive fetal risk are gathered from human studies – one instance is the particular connection between Paxil and heart defects in babies. Pregnancy Category D means Paxil can only be given to expecting mothers if benefits of the drug justify the associate risk.

Many other congenital defects have been soldered to the intake of Paxil during pregnancy especially on the first trimester. The most common of which is PPHN or the persistent pulmonary hypertension of the newborn which is an unusual yet life-threatening birth defect causing multiple organ failure. Other remarkable types are septal heart defects, a condition where the walls dividing the heart chambers are ineffectual due to the presence of the holes on it, and right ventricular outflow tract defects, a condition that prevents efficient blood flow to the lungs.

Over the last 2 decades Paxil and GSK have been dealing with several clamors and legal disputes. July 15 of last year on the New York Times, GSK took a $2.36 billion charge for product liabilities relating to its drugs which includes Paxil. Moreover, GSK also claimed that it had settled "the vast majority of product liability cases" relating to Paxil.

The FDA is recommending health care providers not to prescribe Paxil to women who are pregnant within the first three months of their pregnancy or are planning to become pregnant unless other treatment options are not appropriate. Health care professionals need to carefully assess the condition of the patient. The choice of appropriate drug is so decisive since it may give way for a life-threatening condition to develop on the developing fetus in the mother.