Jump to content
RemedySpot.com

#1 Selling Drug to Kids 17 and Younger ...

Rate this topic


Guest guest

Recommended Posts

Guest guest

.... being investigated by FDA for possible increased risk of mood changes and

suicidal behavior. Singulair is made by Merck, whose previous best-seller

was Vioxx.

FDA Probing Possible Link Between Asthma Drug and Suicide Risk

03.26.08, 8:00 PM ET

THURSDAY, March 27 (HealthDay News) -- The U.S. Food and Drug Administration

said Thursday it was investigating the possibility of an increased risk of

mood changes and suicidal behavior among those who take the highly popular

asthma

drug Singulair.

Singulair is the number one-selling drug among people aged 17 and younger.

Last year, it posted sales of $4.3 billion, making it Merck & Co.'s top-selling

product, according to the Associated Press.

In issuing its statement, the FDA stressed that asthma patients should not

stop taking Singulair without talking to their doctor first.

Both Merck and the FDA noted that the two have been working together over the

past year to determine the scope of the problem and to make appropriate

labeling changes to reflect the potential risk of mood changes and suicidal

behavior among Singulair users.

" Suicide has been reported to us only in post-marketing experience in

anecdotal reports that come to the company, " Philip, head of Merck's

Singulair

development program, told Bloomberg News. The company declined to say how

many suicides have been reported, saying only that it is a " very small number "

relative to the amount of people taking the drug.

The company also released a statement Thursday that detailed the ongoing

review.

" Singulair has been marketed in the U.S. for 10 years and millions of

patients have been prescribed Singulair in the U.S. and around the world. Merck

voluntarily updated the worldwide product label for Singulair in October 2007 to

include 'suicidal thinking and behavior' and included similar changes to the

patient product information, " the company said in its statement. " These actions

were based on a very limited number of post-marketing adverse event reports

that Merck has received. Since that time, Merck has worked with the U.S. Food

and

Drug Administration to provide further clarity in the product label as well

as to further communicate this information to physicians. "

Over the past year, Merck has updated prescribing information for the drug to

include information on several adverse events including tremor, depression,

suicidality (suicidal thinking and behavior) and anxiousness, according to the

FDA. And Merck plans to convey recent labeling changes in face-to-face

meetings with prescribers and also in patient leaflets.

http://www.forbes.com/forbeslife/health/feeds/hscout/2008/03/27/hscout613968.h

tml

**************

Create a Home Theater Like the Pros. Watch the video on AOL

Home.

(http://home.aol.com/diy/home-improvement-eric-stromer?video=15 & amp;

ncid=aolhom00030000000001)

Link to comment
Share on other sites

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...