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Black-box warning and psychiatric drugs: a problem or a solution?

Recently, there is growing concern among psychiatrists regarding the increase in the black-box warning for psychiatric medications, as 794 unique drugs were approved by the Food and Drug Administration. Thirty-five percent (279) of these had a boxed warning, the most severe label associated with adverse drug reactions. The aim of this review was to search for the causes of warning for psychiatric medications and how to remedy this problem. In addition, we aimed to determine the effect of these warnings on our practice with regard to current drug regulations in Egypt. A search in the Pubmed, MD consult, About.com, and WebMD Health News was carried out. Relevant articles were reviewed. In the last 10 years, most psychiatric drugs have received black-box warnings even for a class of drugs rather than just individual drugs. The laws in Egypt necessitate that all psychiatrists should be up to date in their knowledge about pharmacotherapy, adverse drug reactions, and recent studies on the efficacy and safety of our drugs to advance the future of mental health. In addition, we have to establish our own consensus and drug regulations on the basis of local researches supported by the Ministry of health, education and research.