Oral tablets of paroxetine has been on American markets since 1993 to treat an array of mental disorders, such as anxiety and OCD, and is now being re-branded to treat hot flashes in menopausal women. The problem with this re-branding is that paroxetine is just the generic name for the hotly contested antidepressant Paxil, which has been subject to mass litigation. Our Paxil attorneys remind women considering a prescription to the new drug Brisdelle that it is the exact same drug as Paxil.
The company marketing Brisdelle, Noven Therapeutics, is advertising the new drug as a non-hormonal option to treat hot flashes. Traditional menopause treatments, such as Prempro, are combination drugs containing hormones estrogen and progestin. It was recently revealed, however, that this type of hormonal treatment is associated with significantly increased risks of invasive breast cancer and heart disease.
Reasonably, many women are now looking for a non-hormonal alternative to treat their symptoms – a market Noven recognized and is now targeting with a feminine-sounding version of Paxil. Some women may be surprised to learn that using antidepressants to treat symptoms of menopause is not new; gynecologists have been prescribing these types of drugs to treat hot flashes for many years, though this is being done “off-label,” meaning it is not approved by the FDA.
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That is all about to change with the introduction of Brisdelle, a selective serotonin reuptake inhibitor (SSRI) theorized to help regulate body temperature among other chemical imbalances. The new drug is formulated in lower doses than typically prescribed for depression, so cognitive function may not be so severely affected. It is disconcerting, however, that there have been no large studies conducted on paroxetine’s effect on hot flashes, and the clinical trials associated with Brisdelle are questionable to say the best.
In March 2013, the FDA’s advisory committee voted, in a ten-to-four decision, against recommending Brisdelle for market because the risks clearly outweighed the benefits (more on that later). Members of the panel said that they did not see any discernable difference in hot flash frequency and severity among women taking paroxetine over those taking a placebo. Panelists also highlighted the drug’s illustrious litigation history, and, most importantly, its black box warning.
The FDA is not bound by its advisory committee’s recommendation, however, so Brisdelle was approved anyway. It is worth noting that Noven conveniently excluded women with a history of depression or suicidal thinking from its clinical trial.
Suicidal Thoughts and Behavior
Black box warnings are the most dangerous labels the FDA can place on drugs, alerting patients that the drug they are prescribed to can potentially cause very serious, sometimes fatal side effects. For paroxetine, the black box warning was added in 2004 to include that risk of suicidal thinking and behavior in patients. That label was again amended in 2007 to include the risk of such thoughts, particularly in young adults aged 18 to 24.
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In 2009, Paxil manufacturer GlaxoSmithKline agreed to a $1 billion global settlement to resolve lawsuits concerning Paxil’s devastating effects on its patients. Among the lawsuits included plaintiffs who suffered or had a loved one who suffered suicidal thoughts and behavior, bleeding problems, birth defects in children exposed to Paxil in utero and antitrust claims against the manufacturer’s misleading marketing.
Paxil attorneys at Pintas & Mullins Law Firm have seen the devastating consequences of this drug, and are very concerned that a women patients will be prescribed this drug without knowing its full complications. If you have any questions regarding paroxetine, or any other dangerous drug, contact our firm for a free legal evaluation.