Despite the many serious complaints about Zoloft, a popular antidepressant medication, neither its manufacturer Pfizer nor the U.S. Food and Drug Administration (FDA) has issued a recall of the drug. It is unconscionable that a pharmaceutical company would continue to market a medicine that has been linked to severe birth defects and fatal side effects. But for a recall to happen, consumers must be willing to speak out about their negative experiences with the drug.
Will Zoloft Be Recalled?
The first step and most important step toward getting a drug recalled is to report the adverse effects associated with it to the United States government through the FDA program, MedWatch. According to the program, these can include: "serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics."
MedWatch accepts reports by phone at 1-800-FDA-1088, online with its form at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or a paper copy can be downloaded at http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm to fax or email.
As the FDA becomes aware of side effects and complications of a particular drug, it will evaluate whether the public needs to be protected from the medicine with a recall. Most often, a manufacturer will recall its defective product voluntarily, but the FDA can request and then order a recall as well.
Another avenue for consumers who want to see a drug recalled is to pursue their legal rights and file lawsuits seeking damages for the adverse effects of the medicine. If enough patients express their concern legally, the financial pressure may persuade a manufacturer to pull the drug off the shelves. At this point, there about 100 Zoloft lawsuits that have been filed around the country and consolidated into a multidistrict litigation (MDL).
Still, Pfizer has not indicated that it will recall Zoloft.
Current Zoloft FDA Warnings
Before a recall happens, the FDA usually issues warnings for that medicine. So far, the agency has issued a Public Health Advisory in 2006 to warn about the increased risk of persistent pulmonary hypertension of the newborn (PPHN) for women taking selective serotonin reuptake inhibitors (SSRIs) during pregnancy. Zoloft is an SSRI, the most popular type of antidepressant today.
PPHN occurs when a baby cannot adapt to breathing outside the womb, according to the FDA. This requires immediate intensive care because the condition usually is not diagnosed until the baby is born. Babies of mothers who take SSRIs after the 20th week of pregnancy are six times as likely to be born as PPHN than those in the general population, the agency reports. Furthermore, in about 10 percent of cases, PPHN, which primarily affects the heart and lungs, is fatal.
In 2006, the FDA also warned consumers about Zoloft with another Public Health Advisory regarding Serotonin Syndrome. This condition occurs when the brain is flooded with too much of the mood elevator, serotonin, from unsafe dosing of one or more SSRIs or other medications. The onset of Serotonin Syndrome is rapid with symptoms of high blood pressure, hyperthermia, high body temperature and an increased heart rate. It can be fatal if not caught quickly.
SSRIs, such as Zoloft, have been linked in studies to increased thoughts of suicide in children and young adults through age 24. In 2007, the FDA advised antidepressant manufacturers to include this information in their black-box warnings.
The FDA has issued three formal warnings about Zoloft and other SRRIs, but there are many more studies linking this class of antidepressants to severe complications and birth defects. Consumers must protect themselves by reporting the effects of their medicines and advocating a Zoloft recall.