Michael McGrath (Cork South Central, Fianna Fail)
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To ask the Minister for Health if he has any concerns at the continued availability of a certain drug (details supplied) here in view of the fact that it is no longer legally available in the United States; and if he will make a statement on the matter. [1044/13]

Alex White (Dublin South, Labour)
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Centrax contains the active substance prazepam which is a long acting benzodiazepine. Prazepam shares the characteristics of benzodiazepines in general, including the need to use them for the shortest length of time possible and to gradually reduce the dose when discontinuing treatment to avoid withdrawal symptoms. The product information for Centrax approved by the Irish Medicines Board includes these warnings and recommends a maximum treatment time of 4-6 weeks including the time for the tapering-off process. It also states that extensions to this time period should be based on a re-evaluation of the patient's status by specialist experts.

According to the Food and Drug Administration (FDA) website, Centrax has been discontinued in the US but my Department is not aware of any safety concerns regarding long-term use specific to this medicine other than the general concerns relating to benzodiazepines generally.

Benzodiazepines are known to be associated with dependence and withdrawal symptoms and consequently are primarily recommended for short-term treatment only. My Department is reviewing the Misuse of Drugs Regulations with a view to, amongst other issues, introducing tighter controls on benzodiazepine medicines. My Department has consulted with key stakeholders in relation to the proposed amendments. It is anticipated that new legislation will be introduced early this year.