FDA Wants Suicide Warning Labels on Antidepressants

General Zod · Post by **General Zod** » 2004-03-22 03:31pm

FoxNews wrote: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).

Tsyroc · Post by **Tsyroc** » 2004-03-22 03:41pm

Since they are giving these to people who are already depressed how are they going to prove that the drugs are responsible instead of just not working fast or well enough on these particular patients?

Prozac has been used a lot for awhile now so I would have thought that a problem like this would have shown up sooner.

Stormbringer · Post by **Stormbringer** » 2004-03-22 03:51pm

Yes, it must be the anti-depressants that cause the person to kill themself!

Doesn't the government have anything better to do than this?

General Zod · Post by **General Zod** » 2004-03-22 03:54pm

Stormbringer wrote:Yes, it must be the anti-depressants that cause the person to kill themself! Doesn't the government have anything better to do than this?

keep in mind this is the same administration that ordered an investigation into Janet Jackson's boob flashing incident.

RedImperator · Post by **RedImperator** » 2004-03-22 06:38pm

Brain chemistry is chaotic and little understood, and despite how far pharmacology has come in the last half-century, we're still basically using blunt instruments to achieve fine results. So it's concievable that anti-depressant drugs, while raising seratonin levels to combat depression, throw off some other part of the brain in certain individuals and lead to suicide or suicidal impulses. Clinical depression is not the only known cause of suicide, after all.

Admiral Valdemar · Post by **Admiral Valdemar** » 2004-03-22 06:44pm

I'd have to go with Red on this. The field of neurology is still in its infancy and we have no real working model of the brain, it's far too complicated to just say this drug does that and has these side-effects. A warning would at least act as a safeguard incase a study later on shows evidence for this and then the FDA doesn't get the typical suing action that goes with modern American justice.

Macross · Post by **Macross** » 2004-03-22 08:17pm

Patients on anti-depressants ARE closely monitored.

When I started taking anti-depressants I was going to the doctor every two weeks to get a check up. It took a long time and alot of trial and error experimentation to find the right anti-depressant and the right dosage that worked best for me. Some of the anti-depressants that I took had no effect on me, and some had side effects that were worse then the depression.

The problem is just as much psychological as it is nerochemical. People need to know that anti-depressants are not a quick fix to depression. Its a sad truth that some people taking anti-depressants are already considering suicide. If they start taking a drug, and see no improvement, they get discouraged and this only adds to the problem. They think, " im taking anti-depressants yet not feeling better," and conclude that something is wrong with them, or feel that no matter what they do they will always be depressed. When they reach that state, suicide is seen as the only way out.

When I hear these stories, it sounds to me like these people only see a doctor once, where they are given a perscription with no follow up visits. If this is the case, then the doctor is at fault more than the drug. The doctor needs to make sure that the drug is working, to encourage and work with the patient, like mine did. It took more then drugs to help me deal with my depresion.

Durandal · Post by **Durandal** » 2004-03-22 08:34pm

Stormbringer wrote:Yes, it must be the anti-depressants that cause the person to kill themself! Doesn't the government have anything better to do than this?

You mean like cracking down on "obscenity" and throwing people into federal prisons for simple possession of narcotics?

HemlockGrey · Post by **HemlockGrey** » 2004-03-22 08:49pm

You mean like cracking down on "obscenity" and throwing people into federal prisons for simple possession of narcotics?

What the hell does that have to do with anything?

Tsyroc · Post by **Tsyroc** » 2004-03-23 02:16am

I saw reports on this all over the news today. They want the warning to be on the medication bottles that come from the manufacturers.

My question is. How many of you have ever gotten a prescription where the pharmacy filling it actually gave you a bottle of the drug as it came from the manufacturer? I haven't and I don't think the pharmacy I work at would ever give anyone a bottle like that, and if we did it would still have to have a prescription label on it plus additonal warning labels so you wouldn't likely see what the original bottle said anyway.

I'd really like to see what study they are basing this labeling need on, assuming this isn't just another government "feel good" action.

1)Is there medical proof that the drugs are at fault?

2)Is there proof that the people who committed suicide

took the medication as prescribed?
took it long enough for it to begin to effect them?

Post by **haas mark** » 2004-03-23 03:03am

From what I know, generally the people in that situation are one of two cases:

(a) the antidepressant works so well that it throws them into a manic phase;
(b) the patient is bipolar and the actual meds necessary are mood stabilizers, possibly with or without an antidepressant (with, in my case)

Post by **Darth Wong** » 2004-03-23 03:58am

HemlockGrey wrote:
You mean like cracking down on "obscenity" and throwing people into federal prisons for simple possession of narcotics?
What the hell does that have to do with anything?

It has to do with Stormbringer's preposterous claim that a grand impromptu public experiment with the neurochemistry of living human test subjects is not a subject worthy of government scrutiny.

HemlockGrey · Post by **HemlockGrey** » 2004-03-23 07:55am

But what's the point of bringing obscenity and drug possession into it? It doesn't read like "that's a preposterous claim", it reads like one of MKShep's "Oh yeah? Well how about guns?"

Post by **haas mark** » 2004-03-23 07:56am

HemlockGrey wrote:But what's the point of bringing obscenity and drug possession into it? It doesn't read like "that's a preposterous claim", it reads like one of MKShep's "Oh yeah? Well how about guns?"

It's just an analogy.. and a good one, at that.