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Thought Provoking Issues!

Nine Months to Suicide . . .

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The FDA indicates that it will take nine months to complete its evaluation of Singulair, the popular drug used to treat asthma and hay fever symptoms. Sadly for Cody Miller and his parents this has come too late. Cody Miller was an active boy who took his life on August 4, 2007, seventeen days after taking Singulair.

Merck dismissed the incident as a mere coincidence, but two months after Cody’s death, updated the warning for Singulair to include suicidal thoughts and actions. In the past year Merck has also added anxiety, depression, tremors, along with suicidal thinking and behavior to its list of adverse effects that it provides to doctors about the drug.

Several puzzling questions come to mind:

1. How long has the company or the Food and Drug Administration been receiving anecdotal reports about suicidal tendency of patients taking Singulair?

2. The FDA has asked Merck to look at Singulair study data to ascertain more information about mood changes or behaviors in patients that took the drug.  Given the fact that Singulair had sales of 4.3 billion last year . . . does the FDA really expect Merck to be objective in evaluating the data?

3. Reports have come, “despite being subjective” to Merck from physicians, patients, and patient’s relatives.  Were they fully investigated?

4. Why weren’t the labels updated to reflect these changes quicker? A Merck spokesman stated that they received post marketing events and changed the label inserts, ads and brochures. The spokesman also added that the reps were instructed to pass on the information regarding the updates. Doctors and pharmacists claimed that they didn’t know about the updates.           

The FDA is not suggesting that patients stop taking Singulair, but recommends that they talk to their doctors if they have any concerns.           

It seems that Merck has all the answers.           

But for the mother of Cody Miller, who entered her son’s room—to find that he had hung himself. Where does she turn for answers in the death of her only child?           

As the Millers sit in Cody’s empty room . . . Merck’s updates and the FDA proposed nine months to complete its evaluation . . . have come way too late.

Bradley Booth/Freelance Commercial Writer/Author

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Written by BBooth

March 28, 2008 at 9:56 pm

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