Tramadol: It is important that we are informed of side effects

13 June 2017

Doctors should contact the Danish Medicines Agency if clinical experience shows that the side-effect profile of a medicinal product is not consistent with the summary of product characteristics.

At present, there is some debate in the Danish media about the painkiller tramadol, and a number of doctors have told the media that clinical experience shows that tramadol has a higher addition potential than what is mentioned in the summary of product characteristics.

Consequently, the Danish Medicines Agency would like to stress that it is important that doctors and other healthcare professionals inform us about any side effects that occur more frequently and are more serious than described in the summary of product characteristics.

Tramadol is a pain-relieving substance characterised as a weak opioid. All opioids may be associated with both physical and mental addiction – including the weak opioids. The risk of addiction increases the longer the product is used. Tramadol has been on the Danish market since 1997, and the summaries of product characteristics contain several warnings that tramadol may cause addiction. The summaries of product characteristics indicate that patients should only be treated with tramadol for short periods and under medical control. It also appears that tramadol should not, under any circumstances, be administered for longer than absolutely necessary. Addiction is listed as a rare adverse reaction.

In connection with the Danish Broadcasting Corporation’s research for a documentary about tramadol, the Danish Medicines Agency reviewed new knowledge and literature about the addiction potential of tramadol. We found no scientific studies that could form the basis for changing the information that addiction is a rare adverse reaction as mentioned in the summaries of product characteristics.

A summary of product characteristics is an annex to the marketing authorisation issued in connection with the authorisation of a medicinal product. The summary of product characteristics is approved by the Danish Medicines Agency and contains a short description of the conditions applicable to the medicinal product. Changes to summaries of product characteristics must be supported by data. Consequently, it is very important that we are informed by doctors who treat patients and observe side effects, so that we can collect knowledge about the clinical use of the medicinal product and obtain updated data for the summaries of product characteristics.

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