ADR that result in revision of patient information
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| The United States: FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use |
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In follow-up to the US Food and Drug Administration (FDA) Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) issued on 10 January 2013, FDA is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs.
FDA is also warning that patients who take the sleep medication zolpidem extended-release (Ambien CR) - either 6.25 mg or 12.5 mg - should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities. This new recommendation has been added to the Warnings and Precautions section of the physician label and to the patient Medication Guide for zolpidem extended-release (Ambien CR).
Also included in the updated label are the dosing recommendations previously stated in FDA’s January 2013 Drug Safety Communication: The recommended initial dose of certain immediate-release zolpidem products (Ambien and Edluar) is 5 mg for women and either 5 mg or 10 mg for men. The recommended initial dose of zolpidem extended-release (Ambien CR) is 6.25 mg for women and either 6.25 or 12.5 mg for men. If the lower doses (5 mg for immediate-release, 6.25 mg for extended-release) are not effective, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for zolpidem extended-release. However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm352085.htm
In Hong Kong, there are 15 registered pharmaceutical products containing zolpidem which include immediate-release 5mg or 10mg tablets and modified-release 6.25mg or 12.5mg tablets. All of the products are prescription-only medicines. Zolpidem is also controlled as psychotropic substance internationally including Hong Kong. Related news has been released by FDA and was posted on the Drug Office website on 11 January 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on the same day. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board in the meeting in February 2013 and was concluded that Drug Office will remain vigilant on any new safety update of zolpidem by other regulatory authorities for future consideration by the Registration Committee when necessary.
Ends/ Wednesday, May 15, 2013
Issued at HKT 14:00
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