Paxil: The Good, the Bad, and the Tragic

The Good

Paxil is the registered trademark of paroxitine, first marketed in 1992 by Glaxo-Smith-Kline for the treatment of major depression, OCD and anxiety disorders (including panic attacks). It belongs to a class of compounds called Selective Serotonin Reuptake Inhibitors (SSRIs). The major advantages of this class over traditional medications are their safety profile. Paxil (and other SSRIs) do not have the addiction potential of Valium or Xanax (anti-anxiety medications) and have fewer side effects than some of the traditional drugs used to treat depression. Paroxetine is also very difficult to overdose with – a risk with depressive patients who may contemplate suicide.

These ‘goods’ have led to a few very troubling ‘bads’. The reason is that the reputation of SSRIs meant that general practice physicians felt much more comfortable prescribing them to their patients without a psychiatric consultation and for more minor cases of depression and anxiety. The older drugs were less likely to be prescribed simply because they were thought to be more dangerous. The safer a drug appears to be, the more freely physicians will administer it. After all, it might not help, but it wouldn’t hurt… or so the logic went.

The Bad

It wasn’t until more than a decade after its release that the complaints had mounted up enough where the company had to take action. In 2004, they put the results of clinical testing up on the web. It may surprise some readers that drug companies can fund a study and then never publish the results if they are unfavorable, but a study privately funded is privately owned.

They are, however, required to let the Food and Drug Administration know about any untoward effects of their product on the public. One such came out in 2005 when GlaxoSmithKline informed doctors about risks to fetuses when pregnant women were placed on the medication. This is particularly important because women are twice as likely to suffer from panic disorder as men. Also, the highest risk for the condition occurs in the late teens and early twenties – precisely the age group where women are most likely to have their first child. And many women may have been on the drug for some time, without knowing they were pregnant.

Unfortunately, women who were taking Paxil early in pregnancy put their fetuses at more than a 50% risk of birth defects, with heart defects and pulmonary hypertension high on the list.

The tragic

Paxil had been on the market for 13 years before the information sheet available to doctors changed the uses of the drug from “generally safe for use in pregnant women” to “do not use in pregnancy or women who may become pregnant.” By 2009, the first of hundreds of lawsuits was settled against GlaxoSmithKline (2.5 million).

The question has to be asked: Why did it take so long before the dangers were understood?

The pharmaceutical industry’s position is generally one of “we didn’t know” because testing isn’t done specifically on pregnant women; rather, the standards are to use animal models which didn’t show any abnormalities. This may be the case and sounds reasonable until you look at the time frame – 13 years of sales and treatment data. The question of, “What did you know and when did you know it?” has become the major issue in court cases.

Other dangers:

SSRIs continue to be the source of tragic news with three items in particular causing great concern.

SSRIs (including Paxil) now include information about a withdrawal syndrome, referred to in the company’s literature about the drug as a, ‘discontinuation syndrome’. While the drug continues to be marketed without a DEA warning about being habit forming, the discontinuation syndrome indicates patients do become physically dependent on the medication and it can be dangerous to stop it abruptly.

Court documents indicate that Glaxo-Smith-Kline may have known the drugs were ineffective in teenagers suffering depression and kept the information to themselves. What’s worse, in young adults, there seems to be an increased risk of suicide among those treated for depression with SSRIs.

Finally, as recently as June, 2010, Paxil and other SSRIs have been shown to increase the risk of miscarriage by more than double (68%).

The number of lawsuits these problems have generated now exceeds 5,000.

If you need an attorney to assist with your Paxil case, please contact Solomon Neuhardt.

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