Effectiveness of Warnings Put out by the FDA and Health Canada

By: John Scott
Submitted: 2008-05-14 13:23:43
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Legal systems are not all about the top court. There can be many layers underneath where cases and principles in dispute bubble up as the injured seek justice. One of the most contentious of the current issues in the United States is the idea of pre-emption. That state legislators should be allowed to shield the pharmaceutical manufacturers from liability even though their medications or medical devices may have injured people. The justification is that the Federal Government has delegated the task of regulating the safety of medications and medical devices to the Food and Drug Administration (FDA). The courts therefore do not have the expertise or the right to second-guess the Federal body.

So, here we comes McNellis v. Pfizer Inc. which was decided by the 3rd U.S. Circuit Court of Appeals in tandem with Colacicco v. Apotex Inc. The plaintiffs allege fault because the manufacturers of zoloft and paxil failed to give adequate warnings. Both are Selective Serotonin Reuptake Inhibitors (SSRIs) used to treat depression. Patients taking either zoloft or paxil committed suicide. Although there is a black box notice that warns of the risk to some extent, the FDA refused wording in a stronger and more explicit form. The cases brought before the state courts of Pennsylvania and New Jersey reached opposite conclusions. On appeal, it was decided that state laws do pre-empt the right to claim that there was no adequate warning of the risk of suicide.

Whether the FDA should or should not enforce a more strict labelling system has been the subject of debate for some years. The SSRIs including zoloft are associated with changes in mood, particularly among the young. Now, in one sense, that is exactly what a pharmaceutical company making an antidepressant would want to hear. The medication is supposed to change the mood of those who take zoloft for the better. But moods can swing both ways and, just as zoloft may have its successes, so it may not help or exaggerate depression.

Warning notices are, however, equally two-edged. Also published this month in the Canadian Medical Association Journal is research into the consequences of the warning published by Health Canada that there was an increased risk among younger patients taking SSRIs including zoloft. In the two years after the warning, there was a 25% increase in the number of suicides in Manitoba. Two further facts may be stated: there was a significant reduction in the number of younger patients brought forward for treatment, and a 14% drop in the number of prescriptions written for patients under the age of eighteen years.

When potentially suicidal people go untreated, some will commit suicide. Let us put the SSRIs including zoloft to one side. Therapy and counselling might have saved more lives. But the warning put out by Health Canada was vague. It did not instruct doctors or their patients how to react. Were they to stop prescribing or taking zoloft? Were they to change the dosage of zoloft? What change in the symptoms after taking zoloft might indicate danger? When some parents are ashamed of their children’s illness, it can be difficult to get them to bring their children for treatment. Put out a vague warning with no specific recommendation on how to react, and prejudices are confirmed and the children are left untreated.

The Canadian research only examined the evidence as it affected people under the age of 18 years. We do not know how adults responded to the warning on either side of the Canadian/American border. But Health Canada and the FDA should take greater care in their warnings. Information has no use if you are not told how to use it effectively. It seems that in America, the courts are not willing to allow themselves to be used to penalise the manufacturers if the FDA gets the warnings wrong. I wonder when we can expect research along the Canadian lines to examine the suicide rates in America before and after the FDA’s warning.

Article source: Expert Articles