Parker Waichman LLP

Paxil Birth Defect Trial Set to Start

Much has been written about side effects linked to the antidepressant drug Paxil (generic: paroxetine), including that it can lead to birth defects. Now, drug maker giant and maker of Paxil, GlaxoSmithKline Plc, will have to defend itself in a Philadelphia court next week, reports Bloomberg.com. The trial is believed to be what Bloomberg.com described […]

Much has been written about side effects linked to the antidepressant drug <"https://www.yourlawyer.com/topics/overview/paxil_birth_defects">Paxil (generic: paroxetine), including that it can lead to birth defects. Now, drug maker giant and maker of Paxil, GlaxoSmithKline Plc, will have to defend itself in a Philadelphia court next week, reports Bloomberg.com. The trial is believed to be what Bloomberg.com described as a “test case” for over 600 other cases in which Paxil has been blamed for birth defects. The judge in the Philadelphia cases denied Glaxo’s motion last month to bar punitive damages, said Bloomberg.com.

Patients and their parents claim that internal Glaxo documents show the drug maker neglected to publicize warnings about Paxil’s risks until it was compelled to do so by the U.S. Food and Drug Administration (FDA) in 2005, said Bloomberg.com. Paxil was approved by the agency in 1992.

The trial is set to begin September 14. Two other such trials are also scheduled in Philadelphia’s state court for later this year, according to Bloomberg.com. Glaxo is also in lawsuits in the United States, Canada, and the United Kingdom over claims Paxil causes homicidal and suicidal behavior.

Last year, said Bloomberg.com, Paxil generated approximately $942 million in sales, which represents less than three percent of Glaxo’s total sales.

According to the FDA, in late 2005 it sent an alert to physicians about early studies suggesting Paxil could be a contributor to heart defects in babies when taken by expectant mothers in the first trimester, said Bloomberg.com. The government asked Glaxo to update medication information warning on birth defects.

Plaintiff attorneys claim Glaxo’s paperwork prove it was aware Paxil could increase birth defect risks as far back as 1980 and that it did not fully research Paxil before—and after—release to market, said Bloomberg.com. “There remains the possibility that this compound could be teratogenic at higher dose levels. A teratogenic agent is one that causes malformations of an embryo or fetus,” wrote company scientist John Baldwin in a 1980 memorandum, quoted Bloomberg.com.

Plaintiff’s lawyers wrote, “In the face of this warning from Baldwin, GSK chose not to perform any additional animal studies to explore the teratogenic effects of Paxil,” reported Bloomberg.com. Also, according to the Bloomberg.com report, in 1993, Glaxo destroyed raw data from animal studies; in 1996, 1998, and 2000, it withheld safety reports detailing adverse reactions in mothers who took Paxil; and in 1994, supported a low-dose study “as the best way forward and having an acceptably low risk of triggering adverse labeling worldwide,” citing meeting minutes.

In 2005, the FDA, citing a Swedish study, indicated a two percent increased risk of birth defects in infants whose mothers took Paxil in early pregnancy, two-fold higher than the general population, said Bloomberg.com. The FDA noted that another study found the risk in Paxil users was 1.5 percent with one percent for those on other anti-depressants, said Bloomberg.com.

As we have been reporting, some anti-depressants, including Paxil:

Are known to affect sexual functioning in men and women

Have been found, in men, to impair fertility, sperm, erectile function, and ejaculation

Might interfere with the efficacy of breast cancer medication, tamoxifen, leading to recurrence of breast cancer

Are linked to cardiac arrest in some studies; are linked to an increase in the risk for sudden cardiac death (SCD) in a study of women with no cardiac history; and are known to cause a number of cardiovascular side effects, such as irregular heart rhythms and potentially lethal arrhythmias, in some

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism Christina (Tina) Paralegal is a true professional and has excellent customer service skills. Tina is friendly and helpful with my case. Tina also is respectful and compassionate toward me. I have refer others to Parker Waichman LLP. Thank you
Jacqueline D Bryce
2 years ago
5 Star Reviews 150
I am happy to choose Parker Waichman to handle my case. They are very professional and attentive, they always answer any questions I have. I also thank Denny Tang, Kathy Núñez and Jorge Peniche for making me feel comfortable with their help. Thank you for everything you are doing for me.
Francisco Aviles
5 years ago
5 Star Reviews 150
Excellent service
Cris Valdueza
6 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038