UK To Pharma: Update Antidepressant Warnings
4 CommentsBy Ed Silverman // February 5th, 2008 // 2:38 pm
The Medicines and Healthcare Regulatory Agency is reminding drugmakers to upgrade the warnings on all antidepressants - not just SSRIs - after reviewing an FDA analysis of the drugs. As a result, the labeling on these meds should be updated to reflect an increased risk of suicidal thoughts and behavior among young adults and the need to monitor patients closely. The list of drugs that will feature the upgraded warning includes Wellbutrin; Celexa; Paxil; Cymbalta; Lexapro; Prozac; Luvox; Remeron; Serzone, Zoloft and Effexor.
“The Pharmacovigilance Working Party considered the review performed by the FDA was of high quality and although it did not provide evidence to suggest that the use of SSRIs and related depressants leads to an increased risk of suicidality in the general adult population, it found a clear age effect with younger age groups having higher odds ratio estimates than older age groups,” the MHRA announcement states.
“The results of the review found no marked differences in terms of risk of suicidal thoughts or behavior across the different antidepressant classes. In the light of the results of the FDA review the (working party) agreed that the (labeling) of October 2005 should be modified with regard to suicidality and should now be extended to cover all antidepressants.”
UPDATE: An MHRA spokesman writes us to say that “we informed prescribers back in December 2004 about the increased risk of suicidality relating to the whole class of SSRI drugs, and warnings have been in place on the products since then. The piece on our website is aimed at manufacturers, we are basically asking them to make these warnings more prominent to ensure total clarity.”
Matt
It is a strange idea to me that people accept suidical and homicidal side effects as acceptable…
Truthman
I don’t think people ever did accept homicidal and suicidal thoughts as acceptable side effects of SSRI’s…
It’s the manufacturors faliure to warn if these side effects which is the most unacceptable part if this equation..
Barb in Houston TX
LYRICA by PFIZER (as adjunct therapy fo epilepsy)
On or about Jan 25th prior to going for a walk, I alerted our doorman to call me on my cell phone if I did not return in 30 minutes. (I feared I would step in front of a car…a thought that consumes me)
On or about Jan 28th I sent an email to my family telling them if they ever get epilepsy to just f*****g slit their throat.
I stayed in bed…did not go out…just bloody images in my mind of me with a slit throat or crushed by a car.
Jan 30th…Dr Visit…I tell him I have found out from Medicare that LYRICA is a controlled substance and I want off. He says ok. I can’t stop crying in his office. I never mention the feelings of suicide. I did not associate it with LYRICA. I had never had suicidal feelings or behavior before. I had only been on full dosage of LYRICA for a few weeks when the very rapid decent began.
I am slowly tapering off LYRICA…some withdrawal symptoms.
Feb 5th…FDA issues a warning on anticonvulsants that their is an increase risk of suicidal behavior. FDA will try to persuade drug mfgs.in USA to add a “black box” warning to it’s consumer inserts.
How cose did I come to death?
Lee
Youth have a high suicidal rate already, yet no mention has been made of the impact and risks associated with teens or other youth? It matters to me when a Grandson is taking one of the medicines