New Antidepressant Labeling Proposed by FDA
Thursday, December 14, 2006
Ethan Hays
This recommendation came as a result of an FDA review of 372 studies conducted about 11 drugs including Prozac, Zoloft, Lexapro, and Paxil.
Analysis of the combined studies showed a small but significant elevation in risk to young adults - 2 percent reported thoughts of suicide or suicide attempts when on a placebo, compared to 4 percent on antidepressants.
This doubling in risk is "about as unequivocal a result as you can get,” said Dr. Marc Stone, a senior F.D.A. reviewer and an author of the report. "We can't ignore it."
Antidepressents have carried a "black box warning" about the increased risk of suicide for teens since 2004. This warning, located in a black-bordered box above the prescribing information, is the strongest that the FDA can require. Some doctors are worried that including adolescents in this warning will induce a "black-box panic" that could discourage people who need these medications from taking them.
“We’re talking about a devastating, chronic and recurrent disorder, and a black-box warning may serve as another barrier to care that people need,” said Dr. Carol Rabinowitz, president-elect of the American Psychiatric Association. "There is a danger when we paint a medicine as so scary or so potentially dangerous that people avoid it."
Dr. Rabinowitz continued, "Untreated depression causes more loss of life than any of the approved treatments. A black box for adults creates a fear mentality, not only in patients but in doctors...It can limit access to needed care."
Despite such concerns, the committee members are taking the results of these studies very seriously. Remarked Daniel Pine, chief of child and adolescent research at the National Institute of Mental Health and the panel's chairman, "The data are really pretty clear to me and to all the committee members. We need to look at the is issue pretty carefully and the public needs to know more."
6 Comments:
At Wed Dec 20, 07:10:00 AM 2006,
Anonymous said…
A close friend died a year ago. He was 44 at the time of his death. He was an extremely successful executive with a loving wife and two beautiful children. He was diagnosed with depression. He was on serval different medications during a two year battle with trying to improve. After his death his wife and I went online and research all the medications. Three of four medications had warnings of suicide and stated that family members/friends should be aware of the potential risk. She had stated that his doctor never discussed this with her. Unfortunately, we can not undo the damage that has been done to this family, but hopefully everyone who is involved with treating, taking, and living with this problem will become extremely involed!
At Mon Jan 01, 02:09:00 PM 2007,
Jolie Bookspan, M.Ed, PhD said…
Ethan thank you for this life-saving post.
Why should our choice be limited to the "loss of life from untreated depression" and the increased depression and loss of life that some of these medicines are documented to continue to produce? These and several other classes of medicines for other, unrelated problems can bring about or worsen depression, as do several foods and life choices. It is not an outlandish idea to instead, address and stop the cause rather than choose between two problems.
At Thu Mar 29, 08:05:00 AM 2007,
Anonymous said…
i am in a very depressed state and have recently started on lexapro i also have hepatitis c which has lead 2 fibrosis of my liver i am concerned about whether or not this medication is ok to take as i will b starting treatment for my hepatitis which also has side affects of suicide thoughts i have had no suicidal thoughts as of prior just wondering if anyone could give me some information on this.
At Thu Mar 29, 04:52:00 PM 2007,
Ijeoma Eleazu, PharmD said…
To Anonymous:
Hi, my name is Ijeoma Eleazu, I am a Clinical Pharmacist and one of the clinicians here at Healthline.
According to the Lexapro manufacturer’s (Forest Laboratories) labeling guidelines, they recommend a dosage of 10mg per day of Lexapro for people who have impaired liver function.
According to the FDA:
Suicidal thoughts or actions: Persons taking Lexapro may be more likely to think about killing themselves or actually try to do so, especially when Lexapro is first started or the dose is changed. People close to persons taking Lexapro can help by paying attention to changes in user’s moods or actions. Contact your healthcare professional right away if someone using Lexapro talks about or shows signs of killing him or herself. If you are taking Lexapro yourself and you start thinking about killing yourself, tell your healthcare professional about this side effect right away.
At Thu Dec 13, 10:10:00 AM 2007,
Marti said…
can 20mg Lexapro cause hair thining I am 71yrs old
At Fri Dec 14, 10:28:00 AM 2007,
Ijeoma Eleazu, PharmD said…
Hi Marti,
tha manufacturer of Lexapro does not list thinning of the hair as a side effect but this does not mean it is not possible. Here is a link to their list of the adverse effects of Lexapro. I hope it is helpful to you.
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=5814
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