Dextropropoxyphene ban in India: Is there a case for reconsideration?
- 1*
- 1Department of Psychiatry, National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, India.
Published in Journal of Pharmacology and Pharmacotherapeutics
Correspondence: Yatan Pal Singh Balhara
Department of Psychiatry, National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi, India.
Email: ypsbalhara@gmail.com
Copyright: © 2014 The Author(s). This is an open access article.
Abstract
Dextropropoxyphene is a synthetic weak opioid used as analgesic both as standalone as well as in combination with acetaminophen for more than 50 years. Ministry of Health and Family Welfare, Government of India has issued a gazette notification (dated May 23, 2013) suspending the manufacture, sale, and distribution of dextropropoxyphene and formulations containing dextropropoxyphene in the country. This suspension has led to debate about the reasons behind this decision and its implications. India is not the first country to withdraw dextropropoxyphene as it has already been withdrawn from various countries including Australia, Canada, European Union, New Zealand, UK, and USA. UK was probably the first to issue a notification regarding its withdrawal in January 2005. Later on it was withdrawn across the European Union in 2009. Subsequently, recommendations against its use were issued by the US Food and Drug Administration (FDA), New Zealand, and Canada in the year 2010. Australia issued a notification recommending against its use in 2012. All preparation containing dextropropoxyphene (including combinations with acetaminophen) have been withdrawn in these countries. Notably the withdrawal of dextropropoxyphene/acetaminophen combination containing preparations in Australia has been withheld pending a review sought by a pharmaceutical company in the court.
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