STORM2K

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.

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Lindaloo wrote:I have a 45 year old sister who is on Prozac. She is now psychotic.

Stephanie wrote:

Lindaloo wrote:I have a 45 year old sister who is on Prozac. She is now psychotic.

GREAT!

I certainly hope that her doctor has her on something different. Sometimes the medication that is prescribed isn't the appropriate one.

Don't joke about that Jara. For me, Porzac has been a lifesaver. The one time I came off of it, I had a nervous breakdown and WAS suicidal. Talk to you doctor about your concerns. I'll be quite honest though, I still have fleeting feelings of depression and dark thoughts. The difference is that I CAN tell myself now "it's not worth it".

stormchazer wrote:

Stephanie wrote:

Lindaloo wrote:I have a 45 year old sister who is on Prozac. She is now psychotic.

GREAT!

I certainly hope that her doctor has her on something different. Sometimes the medication that is prescribed isn't the appropriate one.

Don't joke about that Jara. For me, Porzac has been a lifesaver. The one time I came off of it, I had a nervous breakdown and WAS suicidal. Talk to you doctor about your concerns. I'll be quite honest though, I still have fleeting feelings of depression and dark thoughts. The difference is that I CAN tell myself now "it's not worth it".

I joke...keeps me relaxed. I'm glad Prozac is working for you.

GalvestonDuck wrote:IMO, chronic depression and several other chronic mental disorders should be treated with both medication to control the chemical imbalance and therapy. The therapy would serve to assure that a patient's emotional well-being is staying in check (since the medication's side effects are in question). Therapy also offers a more hands-on approach to the patient's care -- one-on-one, personal, and confidential discussions about how the patient is feeling and coping -- whereas medicating is just a way of saying "Here take two of these and you'll feel better," a method which doesn't always work by itself.

However, not all mental disorders require nor should they be treated with medication. Sometimes therapy, reassurance, and behavioral modification can help a person overcome something like associative depression (acute depression which results from a certain traumatic or stressful situation and how the person copes with it - death in the family, breakup, loss of job, etc.).

I think some doctors are too quick to prescribe medication without completely diagnosing and understanding the patient's problem. A pill won't always fix everything and sometimes the disabilities associated with the side effects make matters worse.

GalvestonDuck wrote:A pill won't always fix everything and sometimes the disabilities associated with the side effects make matters worse.

ColdFront77 wrote:

GalvestonDuck wrote:A pill won't always fix everything and sometimes the disabilities associated with the side effects make matters worse.

Excellent point, Shawn. This the main reason why I don't want to take anything for my Asperger's Syndrome. I really don't get depressed, more annoyed with things, but I live each day as it comes. Coming here to Storm2K, other boards and elsewhere online is very enjoyable.