A recent study published in renowned medical journal BMJ has brought renewed attention to concerns surrounding the antidepressant drug Paxil (paroxetine), fourteen years after a different study was heralded as demonstrating its effectiveness and safety in teen patients.
The BMJ study itself represents a novel approach in scientific research, in that could be thought to encourage more than one interpretation of identical experiments. In addition, it calls into question the use of Paxil in several types of individuals, including teens.
Original Paxil study possibly flawed
In the late 1990s, SmithKline Beecham, now known as GlaxoSmithKline, launched the original Paxil study to explore the ability of teenaged patients to safely use the antidepressant medication. Depression scores of three groups consisting of roughly 90 teenagers each were tracked over eight weeks, with one group taking Paxil, one taking a placebo and one taking an older depression treatment drug.
Critics of the study quickly came to the forefront, alleging that the data cited for the drug’s safety was secondary in nature and that the very severe side effects experienced by some of the test subjects were downplayed, giving a false sense of security.
GSK defended the study’s methods and stood by the conclusions. Once the study became public, prescriptions written for teenagers skyrocketed. That growth slowed significantly, however, when the U.S. Food and Drug Administration ordered the addition of strong, so-called “black box” warnings on labels of antidepressant drugs such as Paxil.
New analysis triggers criticisms
The original Paxil study has now been the subject of reexamination, with many of the same criticisms emerging as before. It is alleged that the data used in support of Paxil’s use in certain patient populations does not demonstrate clear effectiveness of the drug for its intended purpose.
Critics claim once more, this time in a formalized, published report, that serious complications and side effects did not get sufficient attention the first time around, potentially exposing patients to unnecessary levels of risk of suicide, aggression and worsening of their depression.
Risk of Paxil and birth defects
Reassessment of the early Paxil research comes on the heels of another study in the BMJ that links the use of older antidepressant drugs with an escalation in the risk of birth defects. The study found that while popular medications Zoloft, Celexa and Lexapro did not increase the likelihood of such defects, Prozac (fluoxetine) and Paxil did result in a rise in the danger.
The study found that women who used the antidepressants during the early stages of pregnancy had babies with birth defects at a rate 2 to 3.5 times higher than women who had not used them. Paxil was linked to anencephaly, a defect in which the child is missing portions of the brain and skull and also a defect causing the child’s intestines to protrude on the outside of his or her body. Heart defects were also found to be connected to Paxil use during pregnancy, though researchers were able only to demonstrate links, not necessarily causation between Paxil use and harm of these types.
If you or someone you love has been harmed as a result of using Paxil or any other drug you were led to believe was safe and effective, the product liability lawyers of Edelman, Krasin & Jaye are prepared to help. For a no-cost initial consultation to discuss your case and all available legal options, contact us at 1-800-469-7429.