Paxil, the brand name for paroxetine, was approved by the FDA in 1992 for treatment of depression and is one of the most widely prescribed psychiatric drugs. GlaxoSmithKline, the drug company that manufactures Paxil, has been accused of withholding important information regarding severe side effects of Paxil, which has led to life-altering, life-threatening, and sometimes life-ending consequences for patients who believed the drug to be safe. At least 5,000 lawsuits have been filed against the drug maker for failure to warn consumers of the risks of taking Paxil.
Paxil falls under a class of antidepressant drugs called SSRIs, or selective serotonin reuptake inhibitors. An SSRI blocks reabsorption of serotonin, allowing serotonin to remain in the brain and increase, which shifts the mood to, essentially, make one feel happy rather than depressed. (Worthy of note: There is no actual way of measuring the amount of serotonin in the brain.) SSRIs became wildly popular when they first hit the market in the early ‘90s, and doctors prescribed them almost indiscriminately to anyone with symptoms of mild to severe depression, obsessive-compulsive disorder, or anxiety, even though SSRIs were intended solely for people with severely low serotonin levels, not those with mild depression, anxiety, or obsessive-compulsive disorder. Paxil is also prescribed for conditions including post-traumatic stress disorder (PTSD), premenstrual disorder (PMDD), chronic headaches, and diabetic neuropathy.
According to the American Medical Association, SSRIs like Paxil are no more effective in treating depression than a sugar pill. However, patients have been hearing an entirely different story from physicians over the past 14 years, and the side effects and risks have far outweighed the benefits for many who were prescribed Paxil.
When Paxil was released by GlaxoSmithKline, the company claimed that the medication was safe for adolescents (children under 18) for the treatment of depression, anxiety, and obsessive-compulsive disorder. But early case studies, which were withheld from the public by GlaxoSmithKline, showed that Paxil was neither safe nor effective for children. Not only did GlaxoSmithKline withhold this information regarding the ineffectiveness of Paxil for adolescents, they also failed to disclose evidence-based information that the drug could potentially worsen suicidal behavior.
Had GlaxoSmithKline shared this information, the lives of adolescents could have been saved—children who didn’t live to see their teen years due to suicide. Despite reports of Paxil increasing suicidal tendencies, the company went forward with their 2001 marketing strategy stating that Paxil demonstrated “remarkable efficacy and safety in the treatment of adolescent depression.”
Paxil also causes severe withdrawal symptoms, making it very difficult for a patient to simply stop taking the medication. Nightmares, insomnia, fatigue, anxiety, nausea, and emotional disturbances are common symptoms of withdrawal from Paxil. GlaxoSmithKline promoted Paxil as non-habit forming, despite being aware of the drug’s severe withdrawal symptoms as early as 1993.
Another devastating side effect of Paxil is the high risk of birth defects. Though Paxil was classified as a medication with “no known side effects” when it was introduced, using Paxil during pregnancy puts newborns at risk for a lengthy list of dangerous illnesses. Unfortunately, studies show that 13 percent of pregnant women are taking an SSRI, as doctors continue to prescribe these medications despite the risk of birth defects. The likelihood of a child having autism increases by 200 percent if the mother uses an SSRI while pregnant. Persistent Pulmonary Hypertension of the Newborn (PPHN) is a very serious illness that is also among Paxil’s known side effects. PPHN causes abnormal blood flow and oxygen deprivation, which leads to multiple organ failure. Approximately 20 percent of infants with PPHN will not survive, and those who do survive are often left with long-term breathing difficulties.
Birth defects of the newborn’s heart are the main risk of Paxil use in pregnancy. Left heart syndrome (undeveloped heart), pulmonary stenosis, coarctation of the aorta (narrow aorta), septal defect (hole in the heart), and transposition of the great arteries are often seen as the result of Paxil use during pregnancy. Other birth defects include spina bifida, cleft palate, cleft lip, clubbed feet, neural tube defects, craniosynostosis, and abdominal defects.
GlaxoSmithKline has downplayed the side effects of Paxil for 14 years, but after so many serious injuries and deaths, it’s time the company be held accountable for its failure to warn users of the dangers of the drug. Those who have been affected, and their loved ones, deserve compensation for losses caused by trusting in physicians and drug makers who fail to inform them of the risk they may be taking when they use certain drugs.
If you or your loved one took Paxil and suffered side effects, we will review your case at no cost to determine if you or your loved one may be eligible for compensation for injuries, medical bills, lost income, pain, and suffering. Many who have suffered severe side effects from Paxil are coming forward to seek justice and appropriate compensation.
To arrange a free evaluation of your case and explore your legal options, call Macaluso & Fafinski today at 718.364.4000 (in the Bronx) or 212.480.9000 (from elsewhere in New York), or simply fill out our convenient online form, and we will respond as soon as possible. The offices of Macaluso & Fafinski are conveniently located to serve the five-borough area and its residents.