Mothers Push for Singulair “Black Box” Warning


The Cleveland Plain Dealer reported that the FDA “recently told the makers of Singulair and three less widely used asthma drugs — Accolate, Zyflo and Zyflo CR — that the drugs’ labels must list a dozen mood and behavior changes as possible side effects.” The article focuses on a group of mothers who had pushed for the warning. “The group’s goal now is to get a ‘black box’ warning for Singulair.”

From the American Association for Justice news release.

3 Comments For This Post

  1. sarahsmom
    July 7th, 2009 | 8:15 am

    I am a mother who has lost her daughter to this medication. My daughter completed suicide after three horrible years on this medication. I am so grateful that the word is finally getting out so that other children do not have to suffer. Nothing will give me back my beautiful daughter, but saving other parents from this suffering does bring me some peace. The FDA MUST protect our children!

  2. lynne faraone
    July 9th, 2009 | 7:41 am

    I am the mother of the boy featured in the story,i cannot express to you enough how awful the effects of this drug are,and yet i feel as though i was one of the lucky ones,my child is still here and recovering,while way to many are not.The process of getting this warning was way to hard,who knew protecting children would be a full time job.I do question as to why they finished their investigation in April,but did not release it till June,when allergy season was about over,a short time before the stock market closed,on a busy news friday afternoon,when Iran was holding its elections,i think we all knew that would be a huge story.

  3. Bob Kraft
    July 10th, 2009 | 2:40 pm

    Thank you for sharing your story with us. I hope you will use this experience to continue to crusade for tighter drug regulation.

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