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Women’s health issues incorporate drug safety


Table of Contents

The 16th Annual National Women’s Health Week is being observed this week. An observance led by the U.S. Department of Health and Human Services, the special week began on Mother’s Day and will run through Saturday. Although improving women’s health is the fundamental objective, this observance happens to occur when a lot of women are focusing on risks linked to the use of certain drugs.

“The goal is to empower women to make their health a priority,” according to a department statement. “The week also serves as a time to help women understand what steps they can take to improve their health.”

The HHS Office on Women’s Health invites women to take healthy steps, to include spreading the word about the week through social media by using the hash tag #NWHW. Another major step is to take the National Women’s Health Week Pledge, the specific activities of which are based on age. For instance, the office invites participants in their 20s and 30s to vow that they will at least:

  • Get an annual well-woman visit
  • Get blood pressure checked
  • Eat healthy
  • Maintain a healthy weight
  • Get at least 30 minutes of exercise most days
  • Quit smoking or don’t start
  • Limit alcohol use
  • Get a seasonal flu shot
  • Ask what other shots are needed
  • Talk to doctor about any domestic and interpersonal violence

Unfortunately, a lot of women are reminded this week of health risks that certain drugs pose that could have been averted had the patients known about them. For instance, women across the country have filed Zoloft lawsuits after learning – sometimes too little, too late – about the antidepressant’s suspected birth defects risks. For these women, any discussion about women’s health must take into account the times when drug makers allegedly fail to issue risk warnings for drugs that affect women and their babies disproportionately.

Nearly 600 federal Zoloft lawsuits are centralized before a single judge for pretrial management at U.S. District Court of the Eastern District of Pennsylvania. The panel of judges that in April 2014 grouped those cases before the multidistrict litigation court determined that those Zoloft lawsuits “share factual questions arising out of allegations that Zoloft causes birth defects in children whose mothers ingest the drug while pregnant.”

The birth defects claims were not pulled out of thin air. Some studies confirmed the risks. For instance, researchers at the Boston-based Slone Epidemiology Center interviewed mothers a year after delivery in more than 600 clubfoot cases and in more than 2,000 non-malformed cases between 2006 and 2011 in Massachusetts, New York, and North Carolina. The journal Epidemiology released the findings in its November 2014 edition. Researchers asked the mothers whether they used a selective serotonin reuptake inhibitor antidepressant to treat their depression or anxiety during pregnancy. Zoloft (sertraline) was one of those SSRIs.

The study calculated the odds ratio, which “represents the odds that an outcome will occur given a particular exposure, compared to the odds of the outcome occurring in the absence of that exposure.” The definition comes from an article that the Journal of the Canadian Academy of Child and Adolescent Psychiatry published in 2010.

The authors of the Boston-based study concluded, “Our data suggest an increased risk of clubfoot occurrence in relation to SSRI use.” Moreover, “When individual SSRIs were examined, [odds ratios] were elevated for sertraline” and for two other drugs.

It just so happens that a Georgia mother recently filed a Zoloft lawsuit against the drug’s manufacturer, Pfizer, on behalf of her now 10-year-old daughter, who was born with clubfoot. The lawsuit explained that the child has undergone numerous corrective procedures as a baby and throughout her childhood. As the mother claims about her child’s medical care, “Her monitoring continues yearly and will follow her for her entire life.”

The mother, according to her complaint, “was prescribed and took Zoloft during the first trimester of her pregnancy in 2004. Because she and her doctor did not know Zoloft could cause birth defects, including bilateral clubfoot, she continued taking it during her pregnancy.”

Getting to the heart of the matter, the plaintiff claimed, “Prior to initial approval in 1991, Pfizer’s preclinical animal studies demonstrated significant harm to animal fetuses when Zoloft was administered during pregnancy, including increased mortality and birth defects. Pfizer knew about these adverse side effects, yet, without further testing, Pfizer began marketing and selling Zoloft to health care providers and the public. In its promotional activities, however, Pfizer did not discourage the use of Zoloft in pregnant women. In fact, through a variety of methods, Pfizer actually encouraged doctors and other health care providers to prescribe Zoloft to women of childbearing age, women who were trying to conceive and even to pregnant women.”

Other women who used Zoloft during pregnancy and who had a child with birth defects may want to talk to an attorney. The Zoloft attorneys at Reich & Binstock, who have extensive experience in multidistrict litigation and in litigation against big pharmaceutical companies, will evaluate whether there is an entitlement to compensation at no charge. For a free consultation, contact Reich & Binstock either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.

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