View Full Version : FDA Wants Suicide Warning Labels on Antidepressant
ogarchamplin
22-03-04, 18:45
FDA Wants Suicide Warning Labels on Antidepressants
Monday, March 22, 2004
WASHINGTON — Patients on some popular antidepressants should be closely monitored for warning signs of suicide, the government warned Monday in asking the makers of 10 drugs to add the caution to their labels.
Although the Food and Drug Administration's (search) investigation into the possible suicide connection initially focused on children given the drugs, its warning is aimed at both adult and pediatric use.
It isn't clear yet that the drugs actually do lead to suicide, the FDA stressed. But until that is settled, advisers to the FDA called last month for stronger warnings to doctors and parents that the antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects.
On Monday, the FDA followed its advisers' recommendation and issued a public health advisory putting doctors, patients, families and other caregivers on notice to be particularly vigilant for signs of worsening depression or suicidal thoughts at the beginning of anti-depressant therapy or whenever the dose is changed.
The drugs of concern are all newer-generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin. Most are known to affect the brain chemical serotonin (search).
British health authorities sounded the alarm last year, saying long-suppressed research suggests certain antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers.
Because only one drug, Prozac (search), has been proven to alleviate pediatric depression, Britain declared others — drugs called selective seretonin reuptake inhibitors (search) (SSRIs) and their close relatives — unsuitable for depressed youth.
The FDA issued a caution on pediatric use last year, but Monday's action — especially the addition of the warning to drug labels — goes significantly further.
Dozens of anguished parents pleaded with FDA in a meeting last month to add such warnings, citing preteens and teenagers who hanged themselves or slashed their wrists shortly after starting the antidepressants.
Parent after parent described children who had become extremely agitated or anxious shortly after starting the antidepressants, and seemingly sudden impulses that turned deadly.
Harrisburg, Pa
Seroxat (Paxil) leads the way with this and is where most of the documentation lies.
The danger time is mainly in the first 5 days and it is urged now in the UK that people start on a tiny dose and wind it up slowly.
Also, this month it is recommended that the dose does not exceed 20mg a day . Some doctors have been increasing it up to 40mg or even 60mg and there is no evidence that it is of any benefit at all .
Although suicide is the result cited most , the amount of agression and violence demonstrated by new Seroxat users was enormous too - often against other people.
I welcome this although it will undoubtedly put off already anxious people from taking what may be in the medium /long term an extremely helpful and beneficial class of drug and I do not believe every SSRI to be similar in these sideeffcts.
Meg
Watch your thoughts, they become your words...
Watch your words, they become your actions... Watch your actions, they become your habits... Watch your habits, they become your character... Watch your character, it becomes your destiny...
The information only came to light last Thursday when the Committee on Safety of Medicines, which advises the MHRA, warned doctors to keep to 20mg when prescribing the drug to new patients with most types of disorder. Around 17,000 people were given higher doses last year, which could increase the risk of side-effects such as insomnia and nausea.
Doctors have also beenwarned that children and under-18s should not be prescribed Seroxat, which can be addictive and increase the risk of violent behaviour and suicide in some people.
'On Thursday the agency at last published information advising that many thousands of men and women in this country may have been taking Seroxat at a dose that was unsafe.
Meg
Watch your thoughts, they become your words...
Watch your words, they become your actions... Watch your actions, they become your habits... Watch your habits, they become your character... Watch your character, it becomes your destiny...
ogarchamplin
22-03-04, 20:33
quote:Originally posted by Radar
I welcome this although it will undoubtedly put off already anxious people from taking what may be in the medium /long term an extremely helpful and beneficial class of drug and I do not believe every SSRI to be similar in these sideeffcts.
I agree all meds have side effects and i know this one seems severe but i know a lot of people who paxil has helped
Harrisburg, Pa
I agree entirely with you Ogarchamplin.
Literally, millions of people have used it and the other drugs involved and been helped enormously. Indeed , it's been a complete life saver for many.
Meg
Watch your thoughts, they become your words...
Watch your words, they become your actions... Watch your actions, they become your habits... Watch your habits, they become your character... Watch your character, it becomes your destiny...
Since I took my cipralex two years ago it said on the leaflet that it may cause an increase or cause suicidal feelings.
then i panicked about that for a bit!
Emily
Hiya All
Lol Em, know that feeling!!!
Just to put a positive on things as this post has freaked me out slightly.....My mum has been on Seroxat for about 5 years after trying many other drugs for most of her adult life. She was agoraphobic and within about 4 months of taking them she went on a cruise. Without this medication she would still be living in her bedroom.
Also I started having panic in June 2002 and I was feeling suicidal until I STARTED taking SSRI's at which the feeling subsided and apart from panic havent had any severely depressive thoughts since.
love Sarah
xxxxxxxxxx
My friend Tracy is doing a PHD in psychology.
She was taught when she did her degree that prior to issuing anti - depressants to patients, they should be questioned closely on whether they ever had any suicidal thoughts.
This is because a lot of depressed people with suicidal tendancies felt so bad that they couldn't be bothered to do anything about it.
Once they had started taking certain medications, they started to feel a bit better, and had enough energy to actually try to commit suicide.
Before I started on my anti-depressants, I was questioned by my counsellor and my GP on whether I had ever felt suicidial. (Which I haven't - I want my old life back, I just want to loose the sad anxious one!!)
Although I welcome this report, as it will hopefully ensure that patients who need medication get the correct type, and are treated successfully, I would just like to say that taking anti-depressants is the best thing I've done in a long time!
Obviously drug therapy is a very personal thing, but if anybody had just been prescribed medication, and is unsure, based on my experience, I would say give it a whirl. There are lots of negative posts about medication on this site (mainly because people tend to share bad experiences and don't bother writing about good ones), but I started treatment with an open mind, and I can honestly say the improvement in my general well being is dramatic. (I am also doing talking therapy and lead a very healthy lifestyle)
In fact, lots of people keep telling me how much better I look. Not having noticed any difference myself, I'm getting a bit worried about what they mean!!! I hadn't realised that I looked ill!!!!
Charlie
What doesn't kill you makes you stronger.
I think it's great that they put leaflets in with the medication we get.
At one time we were given the pills and that was that. Anything we wanted to know we had to find out for ourselves.
At least now we know what the medication is designed for, how much to take and what side effects it may have.
On the subject of seroxat, I learned something very interesting the other day.
Apparently doctors have been prescribing to higher starting doses, and too higher continuing doses. Medical councils have warned the goverment to issue information to GP's for years, but they haven't - I wonder why that is?
Love, light and Best wishes
Liz xxx
[:p] Panic Monster & Scatty Eccentric
ogarchamplin
23-03-04, 13:13
People are already starting to freak out because they have been on these meds for some time now and think that NOW they are going to kill themselves. Everyone needs to look at the one part of the warning which is
On Monday, the FDA followed its advisers' recommendation and issued a public health advisory putting doctors, patients, families and other caregivers on notice to be particularly vigilant for signs of worsening depression or suicidal thoughts at the beginning of anti-depressant therapy or whenever the dose is changed.
Harrisburg, Pa
razocaine_07
24-03-04, 11:18
for me, i was offered Seroxat when i came off the beta blockers that im currently on. But being 19 i feel that there should be other ways that should be tried first before taking anti depressants. I have felt suicidal alot of times and have even been in the position of hanging myself but the only thing stopping me was the effect it would have on friends and family.
I do athletics, and my coach who im good friends with, is on Seroxat. Originally, he was on beta blockers and found that they made him violently ill. But, seroxat has changed his life around and he has been taking them for nearly 15yrs without any trouble. For me, the beta blockers have got life of the ground.
What i say is that if you are offered any sort of medication, you should do research on the net, and other sources to see what other people in similar situations have done. Then talk to friends and family. What you shouldnt do is make any 'knee-jerk' decisions because of the way you feel.
What people must remember is that these cases of suicide are probably a handful of people in among millions and millions who take the likes of Seroxat and found it to be of great benefit.
Britain tightens antidepressant warnings
Prescriptions include suicidal cautions, withdrawal risks
Updated: 10:42 a.m. ET Dec. 6, 2004
LONDON - Britain’s medicines agency tightened warnings on popular Prozac-type antidepressants on Monday following a review of selective serotonin re-uptake inhibitors (SSRI) sparked by concerns over their safety.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said there should be stronger warnings about the risk of withdrawal reactions after ending a course of SSRI treatment and in most cases the lowest recommended dose should be prescribed.
Young adults should be monitored closely as a precautionary measure when being treated with SSRIs, it added.
The agency appointed an expert group to investigate the drugs’ safety following claims they could make people feel suicidal or aggressive. Some patients also complained about unpleasant withdrawal effects when they came off treatment.
Drugs including GlaxoSmithKline Plc’s Seroxat -- the most widely prescribed among the drug class in Britain -- were banned from use in children last year following evidence that they may increase the risk of suicides.
The review said a modest increase in the risk of suicidal thoughts and self harm for patients taking SSRIs could not be ruled out, but there was no clear evidence of increased risk of suicide compared with other antidepressants.
The MHRA is also conducting a separate investigation into whether GlaxoSmithKline, Europe’s biggest drugmaker, withheld important data from clinical studies on the suicide risk among teenagers taking Seroxat.
Seroxat, known as Paxil in the United States, used to be GSK’s biggest-selling product but it has recently declined in importance following the launch of cheap generic copies in key markets. Eli Lilly & Co has also lost patent protection on Prozac.
Drug companies argue that millions of people have been prescribed SSRIs without suffering major adverse events and that suicidal thoughts are more likely to be the result of their depression rather than the treatment.
Copyright 2005 Reuters Limited. All rights reserved
Meg
www.anxietymanagementltd.com
You cannot conquer fear until you have learned what it is you're afraid of. The enemy is ignorance. Vivian Vance
bluebottle
09-02-05, 16:28
I'm on Lustral for my depression. I think it works but it isn't a cure, I know I have to play a large part in my recovery.
Regards,
Blue
Take little steps
I'm on Lustral too (since October).
I agree, it's not a cure--but it has given me a 'breathing space' for now--& has helped me to sort out in my mind what I am actually panicking about, whereas before I took any medication I was anxious & prone to panic about anything & everything!
It is good that we are now given more info about the possible effects of drugs & that sub-groups, who might be particularly vulnerable to these effects, are monitored.
My current 'drug problem' is related to the withdrawal of Co-Proxamol. GP's will no longer be allowed to prescribe it because it has been cited in what are believed to have been accidental suicide cases. I have been on it for some years, I have arthritis. There are not really any comparable substitutes & my GP has said that it will be difficult to find a suitable pill for many people who use it. So--for me, they have been a little over-vigilant with that one!
Linda.
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