Paxil's harmful effects, manufacturer concealment, and patient experiences

¶ … Paxil

In the 35 years following its development, femoxetine, commonly known by its trade name "Paxil," has been the focus of a growing body of research based on its proven harmful effects, most especially an increased incidence of suicide. The fact that the drug's manufacturer concealed evidence of these harmful effects has added further fuel to the investigatory fires and new findings continue to confirm the harmful effects of Paxil today. To gain some current insights into Paxil's use and how it has affected consumers in recent years, this paper provides the history of the drug, representative evidence from the scientific community that confirms its several dangers, as well as the results of two face-to-face interviews with former Paxil users to identify specific points of convergence with the scientific research as well as differences. A summary of the research and important findings are provided in the conclusion.

Review and Analysis

Background and Overview

The history of Paxil involves a convoluted series of corporate acquisitions and mergers mixed with a great deal of scandal. In 1978, researchers working at a small company called Ferrosan in Denmark developed paroxetine; in 1980, paroxetine was sold by Ferrosan to Beecham Pharmaceuticals, a company that subsequently merged with SmithKline and French to become SmithKline Beecham (SB).

Thereafter, SmithKline Beecham merged in 2000 with Glaxo and became known as Glaxo-SmithKline (GSK), which was the world's largest pharmaceutical corporation at the time.

According to Healy (2004), though, paroxetine languished in limbo for some time before marketing was considered. In this regard, Healy reports that, "Beecham was considering shelving paroxetine because it appeared less effective in clinical trials than older antidepressants. A large study run by the Danish Universities Antidepressant Group later confirmed this. This was at a time when the nonhospital depression market still appeared relatively small, and it was not obvious how a less effective antidepressant, even a safer one, could be expected to take a significant share in this market."

Based on this lack of active interest, other drugs for depression such as Prozac, Zelmid and Luvox gained increasing popularity and market share, beginning what DeGrandpre describes as a "cult of pharmacology" in the United States.

This lack of interest changed a few years later, though, and following a series of aggressive marketing efforts by their manufacturers, by the late 1980s and early 1990s, the use of a wide range of so-called "selective serotonin reuptake inhibitors," or SSRIs, for depression, including brand names such as Paxil as well as Prozac and Zoloft became prevalent in the United States.

In fact, the application of the SSRI acronym to Paxil was not a clinical decision, but was rather the result of efforts to improve its sales. In this regard, Healy advises that, "Marketers within what was now SmithKline Beecham coined the acronym SSRI. Compared to the other serotonin reuptake inhibitors, paroxetine was supposedly the selective serotonin reuptake inhibitor (SSRI). The name worked all too well. It was adopted for the entire group of compounds. Thus Paxil made Prozac and Zoloft into selective serotonin reuptake inhibitors."

In 1992, paroxetine was formally licensed as Paxil in the United States; however, a year before, it has been licensed as Seroxat in the United Kingdom.

While the use of SSRIs such as Paxil was increasingly commonplace among adults in the following years, a more disturbing finding was that Paxil was even prescribed for children as young as 6 years, and Leo even notes that, "In some cases prescriptions were written for infants under twelve months."

Today, Paxil has been implicated in a number of birth defects and to represent other prenatal dangers as well, but these dangers were not acknowledged for several years (which is not to say they were not recognized) by the brand owner and its use continued to be regarded as best practices for depression among pregnant women.

Although Paxil's manufacturer has concealed research data concerning Paxil-induced suicide and manipulated the data in other cases, the U.S. Food and Drug Administration (FDA) and GlaxoSmithKline eventually published statements concerning the drug that indicated adults with depressive symptoms experienced higher rates of suicidality compared to their counterparts taking a placebo. Since that initial admission, other studies have consistently indicated a connection between Paxil use and increased suicidality in depressed adults of all ages and also in young adults with depression, dysthymia, panic disorder, generalized anxiety disorder, and obsessive compulsive disorder.

One clinician who sounded warnings about Paxil's effects a full decade before they were formally confirmed also emphasizes that, "The rates of Paxil-induced suicidality will be much higher in actual clinical practice where the drug exposure typically lasts much longer than 4-6 weeks, patient monitoring is much less thorough, multiple drugs often exacerbate adverse drug reactions, and many patients are already suicidal."

With respect to specific periods of time of use of Paxil during pregnancies, the research to date shows that:

1. First trimester use of Paxil has been linked to increased cardiac malformations in the baby (the FDA labeled Paxil with a D. rating in response);

2. Exposure to antidepressants during the second half of pregnancy is associated with increased incidence of pulmonary hypertension in newborns, which can be a serious complication; and,

3. Third trimester exposure to SSRIs (especially Paxil) has been associated with increased risk of persistent pulmonary hypertension and premature birth.

Beyond the foregoing, other researchers have confirmed that late SSRI exposure exacerbates the risk of neonatal withdrawal syndrome, a condition that is typified by (a) jitteriness, (b) sleep problems, (c) mild respiratory distress, and (d) weak cry. Moreover, while there remains a lack of timely and relevant longitudinal studies, the research to date indicates that Paxil may retard motor development during the first year.

Furthermore, although few studies have looked at long-term effects on the child, some evidence suggests slowed motor development during the first year. These findings indicate that antidepressant exposure is associated with risk of complications to the infant, but data are limited with regard to long-term effects on children (Choate & Ginter, 2011). Finally, patient who quit taking Paxil on their own without consulting their physicians are at risk of experiencing various withdrawal symptoms, making its use problematic for some from start to finish. According to a warning from the deputy director of the FDA's Office of New Drugs, "Stopping these medicines on your own can sometimes create more problems than it solves. A lot of these medicines are associated with withdrawal syndromes, which can be very problematic for many patients, so stopping is something that needs to be monitored carefully by your doctor."

Conclusion

The research showed that paroxetine, marketed under the brand name Paxil as a selective serotonin reuptake inhibitor, has been associated with a wide range of healthcare problems, especially among pregnant women for which the drug remains best practices for many clinicians. The research also showed that many of these dangers have been well-known for far longer than they have been revealed, making the need for further longitudinal studies especially acute. Indeed, Paxil was shown to be a very powerful drug that is capable of stimulating unaware users in ways that further exacerbate preexisting mental health problems. In the meantime, the results of the interviews with Paxil users, Peter and Melissa, clearly showed that the drug is experienced in very different ways by different people, and that close clinical supervision is needed to ensure that none of the numerous adverse outcomes that have been documented are allowed to manifest.