COVID-19 UPDATE: We are open! Our team is working and offering consultations via phone, e-mail, and video conferencing.


New Study Finds Paxil Offers Little Benefit Over Placebo For Treating Depression

Pregnant womanAccording to a new meta-analysis of both published and unpublished data, the antidepressant Paxil (paroxetine) offers, at best, only a small advantage over a placebo in treating depression and anxiety, and exposes users to a potential risk of serious side effects. The study, which appears in the journal PLOS ONE, indicates that the published data from Paxil maker GlaxoSmithKline overestimates the effectiveness of the antidepressant medication. If you took Paxil while pregnant, and your child was born with a major congenital malformation, such as a neural tube defect, contact our knowledgeable Paxil attorneys at Bandas Law Firm to discuss your legal options. With our skilled Paxil lawyers on your side, you can protect your legal rights and pursue financial compensation for your child’s Paxil birth defects and medical bills.


Upon examining GlaxoSmithKline’s unpublished data regarding the effectiveness of Paxil, researchers involved in the meta-analysis found that the drug provided benefits of only two or three points on common rating scales for anxiety and depression, a significant difference from the benefit rating suggested by published Paxil data. “About 80 percent of the effect can be accounted for by the placebo effect,” wrote lead author Michael Sugarman. “It’s hard to argue that that’s clinically significant.” In fact, the study authors explain in their findings that previous research suggests a change of less than three points on those rating scales should be considered “no improvement.”


The findings of this meta-analysis are significant because Paxil and other drugs included in the category of SSRI (selective serotonin reuptake inhibitor) antidepressants have been found to put users at potential risk for serious side effects, especially when taken during pregnancy. According to mounting research, women who take Paxil during pregnancy may have an increased risk of giving birth to a baby with severe birth defects, such as cleft lip, cleft palate, limb malformations, neural tube birth defects and more. Patients taking Paxil and other SSRI antidepressants may also be at risk for side effects like weight gain, drowsiness, suicidal thoughts and a condition known as serotonin syndrome.


Based on their findings, the researchers involved in the meta-analysis concluded that individuals suffering from depression may want to seek alternative treatments associated with better benefits and fewer risks of side effects. “It’s hard to justify these risks given the minimal differences that we see in benefits,” wrote Sugarman. “It’s also not medically necessary to take these [antidepressant] drugs. There are other options available.” For example, previous research has shown that, while drug therapy and psychotherapy with a trained professional have been shown to perform equally well over the short term – less than 12 weeks – psychotherapy is superior to antidepressant drugs over longer periods of time.


According to the researchers, these important findings underscore the need for researchers to have unfettered access to unpublished drug data, in addition to published data from clinical trials that pharmaceutical companies allow the public to see. In 2004, GlaxoSmithKline was sued for failing to disclose data linking Paxil treatment to suicidal thoughts in children, and as part of the settlement, the drug maker agreed to post all clinical trial results online, including those that had never been made available to the public. If you or a loved one has suffered potential side effects of Paxil, such as spina bifida, persistent pulmonary hypertension of the newborn (PPHN) or other alleged Paxil birth defects, contact our experienced Paxil lawyers at Bandas Law Firm today for legal help.