Other safety alerts
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| The United States : FDA Drug Safety Communication : FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs) |
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FDA is to further evaluate the safety of Long-Acting Beta-Agonist (LABAs) when used in combination with inhaled corticosteroids for the treatment of asthma by requiring the manufacturers of LABAs to conduct five randomized, double-blind, controlled clinical trials comparing the addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone. The clinical trials will begin in 2011 and FDA expects to receive results in 2017.
For details, please refer to the following FDA website at :http://www.fda.gov/Drugs/DrugSafety/ucm251512.htm
In February 2010, FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management program called a Risk Evaluation and Mitigation Stratefy (REMS) and class-labelling changes for all LABAs. The news was posted at Pharmaceutical Service website on 19 February 2010 and letters to healthcare professionals advising them on the safe use of LABAs for the treatment of asthma were also issued on the same day.
For details, please also refer to the FDA website at :http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm
Situation in Hong Kong : There are currently 15 registered pharmaceutical products containing LABAs for the treatment of asthma, namely, 10 products contain Salmetrol and 5 products contain Formoterol. The situation will keep in view in light of the latest announcement by FDA.
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