| thetinman wrote: |
Thanks so much for the information, I think a lot of drugs have more severe side-effects on young people, that‘s why I‘m very opposed to prescription drugs for them. All those I know taking Paxil are adults.
I just read where Singulair is shown to cause a higher incidence of suicide in teens, the doctor prescribed it for my son, who has asthma and I refused.
I dust-proofed and did everything I could to keep him off of a prescription and he‘s doing great. He still uses the albuterol inhaler once a night but I‘m glad we avoided the Singulair.
|
If you are interested this is a good article from webmd.com
Original artilcle: http://www.webmd.com/asthma/news/20080327/fda-checks-into-singulair-suicide-risk
FDA Checks Into Singulair Suicide Risk
class="subhead_fmt">Possible Link Between Singulair Use and Suicide Risk Isn‘t Certain; Investigation May Take 9 Months
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By
Miranda Hitti
WebMD Medical News
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Reviewed by
Louise Chang, MD
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March 27, 2008 -- The FDA today
announced that it is working with the drug company Merck to investigate a
possible link between Merck‘s asthma and allergy drug Singulair and behavior/mood changes, suicidality (suicidal thinking and
behavior), and suicide.
The FDA‘s investigation may take
nine months. As of now, there‘s no proof that Singulair directly affects
suicide risk.
Meanwhile, the FDA calls Singulair
"effective" and advises patients with questions not to stop taking
Singulair before talking to their doctor.
The FDA also asks health care
professionals and caregivers to monitor patients taking Singulair for
suicidality and changes in behavior and mood.
Singulair is used to treat asthma
and the symptoms of allergic rhinitis (sneezing,
stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced
asthma. It‘s in a class of drugs called leukotriene receptor
antagonists.
Other leukotriene modifying
medications include the asthma drugs Accolate, Zyflo,
and Zyflo CR. The FDA is reviewing postmarketing reports it has received of
behavior/mood changes, suicidality, and suicide in patients who took Accolate,
Zyflo, and Zyflo CR and will assess whether further investigation is
warranted.
Singulair Time Line
The FDA notes that over the past year, Merck has updated Singulair‘s
prescribing information and patient information to include the following
postmarketing adverse events: tremor (March 2007), depression (April 2007),
suicidality (October 2007), and anxiousness (February 2008).
In February 2008, the FDA and Merck discussed how best to communicate these
labeling changes to prescribers and patients. According to the FDA, Merck
plans to highlight the recent changes in the prescribing information in
face-to-face interactions with prescribers and to provide prescribers patient
information leaflets about Singulair.
In response to inquiries received by the FDA, the FDA has asked Merck to
evaluate Singulair study data for more information about suicidality and
suicide. The FDA is also reviewing its postmarketing reports of behavior/mood
changes, suicidality, and suicide in patients who took Singulair.
Singulair‘s web site includes the most current prescribing information and
patient information for Singulair, according to the FDA.
Drug Companies Respond
"The notification by FDA is
not an indication that they believe that health care providers should change
their prescribing practices based on this alert," George Philip, MD,
Merck‘s senior director of clinical research and chair of the product
development team for Singulair worldwide, tells WebMD. "Instead, if
patients have questions, they should contact their doctor before making any
changes in their use of Singulair and should not stop Singluair on the basis of
this report."
Philip notes that postmarketing
reports "can be quite sketchy and difficult to make solid conclusions and
certainly not sufficient for us to conclude that Singulair has caused any
particular effect."
In 40 clinical studies of some
11,000 patients who took Singulair as part of a placebo-controlled trial, there
were no reports of suicide, according to Philip.
Drug Companies Respond continued...
And in other studies comparing
Singulair to other types of asthma therapies including inhaled corticosteroids and
long-acting beta agonists, out of roughly 3,900 patients taking Singulair and
3,400 using other asthma treatments, one patient
taking Singulair and three patients taking other asthma treatments attempted --
but did not complete -- suicide.
Accolate is made by AstraZeneca.
"AstraZeneca is aware of the posting by the FDA, but to date has not been
asked for any further information," Blair Hains, AstraZencea spokesman,
tells WebMD.
Zyflo and Zyflo CR are made by
Critical Therapeutics. "We are actively reviewing our current safety
database and will take appropriate action if deemed necessary," Linda
Lennox, Critical Therapeutics‘ vice president for investor and media relations,
tells WebMD via email.
Asthma, Allergy Doctors Respond
The American College of Allergy, Asthma & Immunology and the
American Academy of Allergy, Asthma & Immunology issued a joint
statement about the FDA‘s announcement.
"There are no data from well-designed studies to indicate a link between
Singulair and suicide. The concern expressed by the FDA is based entirely on
case reports and there is no indication that such effects apply to other
leukotriene-modifying medications," the statement reads.
The statement also recommends that "based on the information currently
available, patients taking Singulair should continue to take the medication as
prescribed provided: 1) the patient and physician feel the medication is
effective; and 2) the patient does not experience any suicidal behavior or
thoughts. Patients who experience suicidal thoughts or demonstrate suicidal
behavior should consult their physician immediately to discuss whether to
continue with this medication. Patients should not hesitate to consult their
physician if they feel uncomfortable continuing on the medication."
Report Adverse Events
The FDA urges health care professionals and patients to report side effects
from the use of Singulair, Accolate, Zyflo, and Zyflo CR to the FDA‘s MedWatch
Adverse Event Reporting program.
MedWatch reports can be filed the following ways:
- On the FDA‘s web
site
- By returning the postage-paid FDA form 3500 to 5600 Fishers
Lane, Rockville, MD 20852-9787
- By faxing the form to 800-FDA-0178
- By phone at 800-332-1088