Generic Zoloft Approved in 2006, But Manufacturers Held Blameless in Court
The FDA approved Pfizer’s antidepressant “Zoloft” (sertraline) in 1991. Fifteen years later, when Pfizer’s patent on the drug expired, the FDA approved the first generic forms of sertraline in 2006. At the time, patients were excited to have the generic option because of the cost savings. After the 2011 Supreme Court decision ruling generic manufacturers could not be held liable in cases of failure to warn, however, that excitement turned to concern.
Things got even more complicated for patients taking generic Zoloft when reports started coming in about Zoloft side effects, particularly Zoloft birth defects. Mothers taking the drug were sometimes giving birth to children with heart and brain defects, but those who attempted to pursue a generic Zoloft lawsuit in court found the task near impossible. As long as the generic label exactly matched that of the brand name drug, plaintiffs were likely to have their cases dismissed.
FDA approves generic Zoloft
On June 30, 2006, the FDA issued a news release stating they had approved the first generic version of Zoloft. They noted that in 2005, Zoloft was the sixth highest-selling brand-name drug in the U.S., with retail sales totaling over $2.5 billion.
With the approval of the generics, Gary J. Buehler, Director of the Office of Generic Drugs, stated that generics were a safe and effective alternative to brand name prescription products, and provided significant savings to the American public.
The new generic Zoloft tablet released in 2006 was manufactured by IVAX Pharmaceuticals, and approved to treat major depressive disorder in adults. The tablet was distributed in 25-, 50-, and 100-milligram dosages. Teva Pharmaceuticals later acquired IVAX.
Later, Zoloft manufacturer Pfizer released its own generic form of the drug through its subsidiary Greenstone Ltd.
All Zoloft side effects the same
Regardless of which form of the drug patients use, Zoloft side effects remain similar. These include depression, aggression and suicidal thoughts, as well as Zoloft birth defects. Indeed, some studies have indicated that women who take selective serotonin reuptake inhibitor (SSRI) antidepressants like Zoloft may have an increased risk of giving birth to a child with birth defects. These may include persistent pulmonary hypertension of a newborn (Zoloft PPHN), atrial heart defects, limb abnormalities, abdominal or cranial defects.
Individuals filing a Zoloft side effects lawsuit against generic manufacturers, however, have achieved little success in court. After the 2011 Supreme Court ruling, many Zoloft lawyers tried other approaches for holding generics liable, but so far few of these approaches have succeeded. New legislation introduced to Congress in April 2012 seeks to change the law so that generics can have the legal right to change their labels as needed. If the bill passes, it would improve legal options for patients taking generic Zoloft.