Quote:
Originally Posted by Dion
I stand corrected, it was Serzone.
http://www.antidepressantsfacts.com/...off-market.htm
18 Deaths Linked to drug - Serzone Removed from European market, not US
http://www.ahrp.org/infomail/0103/17a.php
The Food and Drug Administration (FDA) today issued a Public Health Advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal thoughts and behavior ("suicidality") in children and adolescents being treated with antidepressant medications.
"Today's actions represent FDA's conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them.
They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us," said Dr. Lester M. Crawford, Acting FDA Commissioner.
http://www.antidepressantsfacts.com/...Is-suicide.htm
Shouldn't the drug companies and their testing catch this before it reaches the market?
It's actions like the above that has me leery of their testing methods.
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Alright, in order then...
1. Nefazodone was pulled from the market before I entered pharmacy school, so you'll have to forgive me as I don't know much about it. I just did some reading, and it appears liver toxicity was the problem. As per the Health Canada advisory, the risk was very low.
"This risk, while very remote, poses a greater risk than other similar antidepressants currently available in Canada."
As I mentioned before, the rarity of these side effects make it difficult to find in phase I, II, or III trials. I couldn't really find any good evidence, but
this article, while admittedly not being the best source in the world, says there were 55 cases of liver failure, resulting in 20 deaths in nefazodone's 9 years on the market. They also say there were 2.8million prescriptions written for nefazodone in 2002 alone in the US. Drug companies will never be able to get that many people in a clinical trial to test for these kind of side effects. In reality, all medications can cause adverse side effects. You can't really avoid it.
2. Clinical trials are typically not done on children. This is a problem, and it is being looked at. However, parents are not really willing to sign up their children for clinical trials.
In terms of that adverse effect, pharmacists and doctors are aware of it. Typically, antidepressants tend to increase one's energy levels before their mood gets better. It's not completely understood, but the problem appears to come from more severely depressed people getting this increased energy first without the elevated mood, and therefore having the energy to attempt suicide. As a health professional, you have to try to get the family involved in a more severely depressed patient's care and make sure they are vigilant. Until the mood elevating effects kick in, the patient is definitely at risk.
As I said, these drugs can and do help some people. Can you honestly say they have no benefit? All drugs have their risks, but you need to weigh the potential benefit against the potential risk. For most people, the benefits greatly outweigh the risks.
As an aside, I am not defending drug companies or the over-prescribing of medication. Any vigilant pharmacist will try to prevent this from happening, although it's not always possible.