1. Home
  2. Activities

OTC: Submission of an opinion letter against changing the risk class of ketoprofen-containing drugs from the highest risk group to the second risk group of OTC drugs


In Japan, over-the-counter (OTC) drugs are classified into three groups according to their risks.

The Pharmaceutical Affairs Act mandates that pharmacists should give consumers explanations and advice when selling drugs that come under the highest risk group. Eighty percent of OTC drugs including cough and cold drugs are classified into the second risk group. Regarding this group, "registered salespersons" (those who have a new license to sell OTC drugs), are permitted to handle OTC drugs, and explanations and advice from pharmacists are only necessary when consumers ask about the drugs.

Recently, an advisory committee of the Ministry of Health, Labor and Welfare (MHLW) announced that six drugs, including those that contain ketoprofen that were switched to OTC drugs from prescription-only drugs and classified into the highest risk group, should now move to the second risk group.

However, these drugs cannot be sold as part of the second group as their risks are too high.
Concerning drugs with ketoprofen in particular, adverse skin reactions including photoallergy can be serious. After reviewing safety and effectiveness, the Committee for Medicinal Products for Human Use (CHMP) of The European Medicines Agency (EMA) concluded that these medicines should no longer be available as OTC drugs but should only be obtained with a prescription, and that more severe warnings on sun exposure should be included in the product information, as well as information on adverse skin reactions when topical ketoprofen is used with octocrylene.

Therefore, we submitted an opinion letter to the MHLW dated November 19, against changing the risk class of the drugs including ketoprofen-containing medicine to the second group of OTC.