Justice Foskett, a high court judge in London, has refused to put GSK’s case to a permanent halt because its claimants’ solicitors, Fortitude Law, claimed that the withdrawal symptoms with Paroxetine (in UK: Seroxat and in US: Paxil) are far more harsh than the other contemporary drugs with selective serotonin reuptake inhibitors. The British Medical Journal (BMJ), reported a study by Le Noury, Joanna, et al. “Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence”, which concluded, “neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs”.
Paroxetine, most commonly known by the brand names Seroxat and Paxil, an antidepressant drug that belongs to a class of SSRIs (selective serotonin reuptake inhibitor), was developed by the Danish pharmaceutical firm Ferrosan in 1975. The firm later sold the rights of the drug to the Beecham Group in 1980 which in 1989 merged with SmithKline Beckman to form SmithKline Beecham. In 2000, SmithKline Beecham merged with Glaxo Wellcome to form GlaxoSmithKline.
In 1992, FDA approved the drwug for obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behavior); panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces); social anxiety disorder (fear or avoidance of social situations); post-traumatic stress disorder (anxiety caused by a traumatic event); and generalized anxiety disorder (generally feeling very anxious or nervous).
Paroxetine was assigned the number 329 in clinical trials. The study plans for 329 were drawn up in 1992 and began in 1994 which ended in 1998. In July 2001, the study was published by American Academy of Child and Adolescent Psychiatry, carried out by Keller et al., (2001), and claimed to be “generally well tolerated and effective for major depression in adolescents”.
Although, the study reported serious side effects in paroxetine group but stated that only headache was considered by the treating investigator to be related to paroxetine treatment (deliberating cover up for the other serious side effects due to paroxetine) and concluded that imipramine, another antidepressant drug with which paroxetine was being compared besides placebo (in a double blind randomized controlled trial), produced significant cardiovascular disorders in depressive patients as a major side effect and had to be abandoned by the patients and concluded that paroxetine gave better and positive results without significant adverse effects in depressive patients and can be a better substitute or alternative for imipramine.
The drug became an instantaneous hit, with annual sales in excess of $3 billion as it went on to become the best-selling antidepressant in the world. Smith Kline Beecham reported in 1993 that with sales up 26% for the first quarter of 1993, and pre-tax profits 12% higher, the company is “making excellent progress; group sales for the quarter amounted to $2.27 billion) and pre-tax profit was $456 million.
However, in 2003, the Britain’s Medicines and Healthcare Products Regulatory Agency recommended that antidepressants like Seroxat should not be used in children or adolescents. Later, in 2005 the European regulators followed the suit.
In 2004, Food and Drug Authority (FDA) issued a black box warning for paroxetine, advising against its use in adolescents, stating that the drug carries an increased risk for suicidal ideation in adolescents, especially in children under 18. Later, reports regarding serious addiction, severe withdrawal effects (lasting for years) and even birth defects, started showing up by the sufferers. Yet, Glaxo continued to deny these facts and stated that the drug Paroxetine was not responsible for such adversities, rather the severity of underlying disease should be blamed for. However, in 2005 a federal judge banned the nation-wide drug supporting advertisements, as they were not only misleading but were also developing inaccurate expectations of the patients towards their prognosis with the use of disease.
Glaxo had a legal fight where it settled 3,200 cases of addiction and other complications. Precisely speaking, they include 150 Paxil-related suicide cases and 300 suicide attempts. Paxil’s risk in pregnancy surfaced another case last year in Philadelphia, which charged Glaxo a penalty of $2.5 million to the parents. 600 other pregnancy-related birth defect cases are also in a queue. Glaxo’s tempering of drug’s side effects has turned in to a staggering amount $1 billion to the law suites and settlements. But the big dirty money Glaxo has made from Paxil sales is far more than the cost of legal lash back.
BMJ analyst claimed after analyzing the first Seroxat study (published in 2001) that the perils of the drug could have been highlighted years earlier.