Did Zoloft Cause Twins’ Birth Defects?

Zoloft is a brand-name antidepressant medication manufactured by the giant pharmaceutical company Pfizer. Zoloft is the brand name for sertraline HCL, which comes in tablet form (25 mg, 50 mg, or 100mg) and as an oral concentrate. Zoloft is approved for use in treating Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Posttraumatic Stress Disorder (PTSD), Premenstrual Dysphoric Disorder (PMDD), and Social Anxiety Disorder in adults, and in treating Obsessive-Compulsive Disorder in children and adolescents ages 6 to17. It is also used to relieve the symptoms of certain premenstrual conditions, including mood swings, irritability, bloating, and breast tenderness.

Sertraline is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.


One of the most common safety warnings regarding Zoloft and other antidepressant drugs is that they may increase suicidal thoughts or suicidal actions in children, teenagers, and young adults, especially during the initial few months after starting to take the medications. However, another important safety warning regarding Zoloft and other antidepressant medications is that women who are pregnant, plan to become pregnant, or who are breastfeeding should not take any antidepressants without consulting their doctor.

In a product liability lawsuit filed on June 4, 2012 against Pfizer that includes a medical malpractice claim against the prescribing medical provider, the parents of twins born in Illinois on June 3, 2010 with birth defects that included heart defects, scoliosis, shortness of breath, developmental delays, and flattening of the skull claim that the birth defects were caused by the mother’s use of Zoloft throughout her pregnancy.

The parents claim that the mother was not warned of the potential for birth defects when she took Zoloft during her pregnancy and that Pfizer failed to provide adequate warnings regarding Zoloft, failed to continue to monitor the safety of Zoloft, and failed to release the results of testing that showed dangers associated with the use of Zoloft. The parents’ product liability/medical malpractice case also alleges the defective design of Zoloft and the inadequate testing of Zoloft by Pfizer.

The parents claims include allegations of breach of express warranty, breach of implied warranty, negligent misrepresentation, strict liability, fraud by concealment, and violation of consumer protection laws.

All medications, whether over-the-counter or prescription drugs, come with risks — but some have more serious risks associated with them than others and the risks may be different for different people (for example, men versus woman, children versus adults, pregnant women versus others). Drug manufacturers and prescribing medical providers must make certain that their knowledge regarding risks, adverse reactions, and safety information is fully disclosed to and discussed with those who are prescribed or provided the medications, which obligation is ongoing as new, further, or other information becomes known or available.

If a drug manufacturer and/or a drug prescriber fail to provide information about the medications that they should have disclosed, they may be held liable for their failures to provide the appropriate information if patients suffer a foreseeable adverse reaction or injury as a result.

If you, a family member, a loved one, or a friend have been injured as a result of a prescribed medication or over-the-counter drug, you should seek the advice from a medical malpractice attorney or medical product liability lawyer who may be able to investigate your possible claim and represent you, if appropriate.

Click here to visit our website to be connected with medical malpractice lawyers or product liability attorneys in your state who may be able to represent you with your claim, or call us toll-free at 800-295-3959.

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This entry was posted on Wednesday, July 4th, 2012 at 10:19 am. Both comments and pings are currently closed.


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