After decades of research and development, British pharmaceutical company GlaxoSmithKline (GSK) patented the drug Paxil in 1986 for the treatment of anxiety, depression, obsessive compulsive disorder, PTSD and certain premenstrual disorders.
Paxil was approved by the FDA in 1992 and has been used by nearly 100 million people in the United States since. The drug has also been sold under the name Seroxat, which is not a Paxil generic, but rather the European version of the same drug from GSK.
In June of 2007, however, the patent that GSK held on Paxil expired and the FDA approved several generic versions of the drug.
Research has shown that both the Paxil generic and name brand versions can dramatically increase the risk of serious birth defects in infants when taken by mothers during pregnancy.
Paxil generic versions are known as peroxetine, and are available from several drug companies including Teva Pharmaceuticals, Caraco, Sandoz Pharmaceuticals, Apotex, Alphapharm, Mylan, Zydus Pharmaceuticals, Aurobindo Pharma and Cygnus Specialities.
Health and legal rights advocates caution patients against taking generic drugs for two important reasons. First, generic drugs can contain different ingredients. Second, by taking generic drugs over brand name drugs, your right to recover for any damages caused by the drug is limited by a recent U.S. Supreme Court decision.
Make sure you confirm with your pharmacist and insurance company that you are receiving name-brand medications. Otherwise, your legal rights may be severely limited if you are injured.
Before the FDA approves the generic version of a medication, the drug must undergo testing to make sure it is comparable to the brand-name version. The agency then assigns the generic drug a rating which demonstrates how similar it is to the original. The rating ranges from an AA for total bioequivalence to B for no bioequivalence.
Some Paxil generic versions carry an AB rating meaning “bioequivalence problems have been resolved with adequate…evidence supporting bioequivalence.” This means these generic drugs should be equivalent to the original. Other generic versions carry no rating since they are repackaged versions of the original.
Although the FDA requires that generic versions of Paxil contain the same active ingredients as the brand name original, they are allowed to use different inactive ingredients such as dyes, fillers, coatings or other ingredients. These can cause problems for certain patients.
The biggest reason why patients should insist on brand name versions of Paxil or other drugs instead of generics, however, is because taking a generic could significantly hurt your legal rights to recover if you are injured from a defective drug.
On June 23, 2011, the United States Supreme Court ruled in the Pliva, Inc. v. Mensing case that generic drug manufacturers may not be held liable for any injuries caused by their failure to warn patients of dangerous risks as long as their label matches the brand name version.
Both the generic and name brand versions of Paxil are classified as SSRI drugs, which have been linked to serious birth defects including club foot, heart defects, abdominal defects, lung defects and neural tube defects of the brain and spine.
If you have taken a generic or brand name version of Paxil and given birth to a child with birth defects, it is important to speak with a qualified lawyer about your legal rights as soon as possible. Contact us today for a confidential evaluation.