Posted on 15/06/2009 in Pharmaceutical Company Product News Merck is confident that Singulair (montelukast sodium) is safe and effective, it has asserted.
After the drug's approval over 11 years ago, more than ten million patients with asthma and allergic rhinitis have been advised to take it.
In order to communicate a range of adverse effects reported from the treatment, the company has updated the post-marketing section of the prescribing information since the medication was first introduced.
Now, the firm has included types of neuropsychiatric events the Food and Drug Administration has highlighted and Merck stated it will continue to work with the regulatory body to revise Singulair's administration advice.
Dr Scott Korn is vice-president of Merck Research Laboratories' clinical risk management and safety sureveillance and commented on the medication.
"For the millions of people suffering from either asthma or allergic rhinitis, Singulair is an important treatment option for appropriate patients," he said.
The company is recommending those with asthma or allergies should discuss any queries regarding the drug with their healthcare provider.
Earlier this month, Merck announced results from a pivotal phase III study of rolofylline (MK-7418) did not meet primary or secondary endpoints.
The medication was being analysed as an acute heart failure treatment.Other news stories from 15/06/2009
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