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Mesalazine and sensitivity to sunlight

Date: 8 February 2017

The Netherlands Pharmacovigilance Centre Lareb received five reports of hypersensitivity to sunlight (photosensitivity) when using the drug mesalazine. Mesalazine reduces inflammation in the intestinal wall and is prescribed for chronic inflammatory bowel disease ulcerative colitis. One reporter said that the complaints occurred every time he was exposed to the sun. The patient remained using the drug despite these complaints.

Hypersensitivity to sunlight is currently not listed in the patient information leaflet (PIL) or official product information (SPC) of mesalazine. However, there are several publications about this adverse drug reaction (ADR). It is important that patients are aware of this potential ADR because it is prevented by avoiding exposure to sunlight or tanning.

The Dutch Medicines Evaluation Board (MEB) will share this ADR within the European network so that any further steps can be taken.

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