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Sep 30, 2005 (UPI via COMTEX) -- This week's warning of a possible risk of suicide from a prescription ADD drug highlights an area that badly needs attention.
The fact is, many widely used legal drugs can cause psychiatric side effects. And not all of them are used to treat psychiatric problems.
That's not meant to be a shocking statement. Any drug powerful enough to affect one part of the body has the potential to affect another.
To make the point, let's pick a cholesterol drug at random, simply because they are the most-prescribed in the United States. According to the official product label, people who took the drug we looked up have reported insomnia, dizziness, amnesia, abnormal dreams, libido decreased, emotional lability and depression.
Many, many other drugs carry similar warnings -- which don't constitute proof but do suggest such problems might happen to some users. Just this week United Press International reported about an anti-malaria drug, Lariam, that a number of Australian soldiers claim made them psychotic and suicidal (the drug's label says others have filed such reports).
When the drug involved is designed to treat mental or behavior problems, the issue gets stickier. For one thing, it's well-known that -- with or without medication -- a patient becomes a greater suicide risk at the exact point when they start to improve. One theory is that they have regained just enough energy to consider suicide but not enough optimism and judgment to avoid it.
Add adolescence to the mix and things get really confusing, which brings us to this week's news that the drug Strattera will now carry a "black box" warning -- a prominent mention outlined in a black box that it might increase suicidal thinking in children and adolescents.
According to The New York Times, the signs of suicidal thinking aren't strong enough for Lilly to change the way the drug, which is used to treat attention deficit disorder, is prescribed. And the article quoted psychiatrists as saying "suicidal thinking is so common, especially among adolescents, that it is not clear what, if anything," the findings that led to the black box actually mean.
Similar issues have arisen with anti-depression drugs such as Prozac and Paxil.
In the middle of all this is the FDA, which faces political and pharmaceutical pressure to get drugs on the market as soon as possible, but also must contend with side effects that emerge after a drug has been approved.
Keeping tabs on previously undetected side effects of an approved drug is called "post-marketing surveillance," and both the manufacturer and the FDA maintain databases of adverse-events reports filed by medical professionals and patients.
In February the FDA announced, somewhat self-congratulatory under the circumstances, "a new emboldened vision for FDA that will promote a culture of openness and enhanced oversight within the Agency. ... FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues, and will provide emerging information to health providers and patients about the risks and benefits of medicines."
The agency was "emboldened" in large part by the Vioxx controversy. The popular anti-arthritis drug was found to raise the risk of cardiovascular problems, and the FDA and the manufacturer were criticized for not acting quickly enough in response. The manufacturer, Merck, voluntarily withdrew the drug.
The FDA's changes increase the likelihood that emerging side effects will be spotted, and warned about, sooner rather than later. The new setup separates the monitoring process from the drug-approval operation.
Still, those of us who take prescription drugs -- which means just about everyone at one point or another -- would do well to remember that our own experience with the drug is part of the evaluation process called a Phase IV Trial.
The first three phases lead up to the approval of a drug. The fourth: "Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use."
Again, it's not shocking that we're all participating in an ongoing study every time we take a pill. Not every possible side effect can be teased out in smaller test groups, and shorter time periods, before drugs come on the market and are taken by millions.
But it makes you want to read the drug label, doesn't it? And if you're starting to feel a little strange, consider the drug as a possible cause, no matter what the label says or doesn't say. You are the Phase IV trial.
Copyright 2005 by United Press International