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Documentation of risk of photosensitivity

April 2011

REPORTING OF MEASURES TO REDUCE THE RISK OF PHOTOSENSITIVITY REACTIONS MEDICINES BASED ON SKIN TOPICAL KETOPROFEN

Medicinal products containing the active ingredient ketoprofen topical skin:

Artrosilene gel and foam, Fastum gel, Flexen gel, Ibifen gel and skin solution, Hiruflog gel, Keplat medicated plaster, Ketofarm gel, Almus ketoprofen gel, Eurogenerici ketoprofen gel, Italy Ratiopharm ketoprofen gel, cream ketoprofen Sandoz, Teva ketoprofen gel, cream Lasoartro , Lasonil gel, gel Liotondol, Orudis gel

Summary

In 2010th the Medicinal Products for Human Use Committee (CHMP) of the European Medicines Agency reviewed scientific data on safety and efficacy of drug containing ketoprofen for topical use on the basis of reports of photosensitivity reactions and co-sensitization by octocrilene (UV filter). The CHMP concluded for a favorable benefit / risk profile of these drugs but considered photosensitivity reactions serious adverse reactions requiring risk reduction measures.
Several regulatory measures were then taken for drugs containing ketoprofen for topical use in order to ensure a safer use, in accordance with the European Commission decision, and in particular:

  1. all drugs containing ketoprofen for topical use are now available only on prescription;
  2. the Summary of Product Characteristics / package leaflet (SmPC / Patient Informative) were amended in the relevant sections to reinforce the precautions for use and to specify contraindications (for a detailed list of changes see Important Informative Note published on the AIFA website, available at http://www.agenziafarmaco.gov.it/;
  3. Important Informative Note has been directed to Healthcare Professionals focusing on risk of photosensitivity by ketorpofene topical drugs;
  4. specific educational programs for physicians and patients have been focused on risk of photosensitization by ketoprofen topical drugs;

Reccomandation to Health Care Professionals

Physician and Pharmacists should remind patients to follow the instructions given in SmPC and recommend:

  1. Avoid exposure to direct sunlight (even when the sky is cloudy), including solarium (UVA) during treatment and until two weeks after therapy stopped.
  2. Use clothing to protect the treated areas from sunlight.
  3. Wash hands carefully after each use.
  4. If any skin reaction occurs after applying the product stop immediately therapy.

Recall reporting

Please note that any suspected adverse reaction following the use of ketoprofen for topical skin should be reported according to the usual mode.

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