New OTC category develops on heels of U.K.'s Cyklo-F approval

LONDON The Medicines and Healthcare Products Regulatory Agency, the U.K. equivalent to the Food and Drug Administration, on Thursday approved an over-the-counter medicine for heavy menstrual bleeding, creating a new OTC category for English druggists.

According to the MCRA, an estimated 1-in-20 women ages 30 to 49 years consults a general practitioners or healthcare professional around heavy menstrual bleeding each year. The condition can lead to mood changes and absence from work, and can severely impact a woman's quality of life.

Tranexamic acid will be available through pharmacies under the brand name Cyklo-F for women aged 18 to 45 years with a history of regular heavy menstrual bleeding over several consecutive menstrual cycles

Women can self diagnose heavy menstrual bleeding and pharmacists will help decide if Cyklo-F is suitable for them.

"Making Cyklo-F available through pharmacies without a prescription is an important step for women, helping improve their quality of life and provide them with the greater convenience of better access to medicines,” stated MHRA Director of Vigilance and Risk Management of Medicines June Raine. "The MHRA is committed to improving access to over-the-counter medicines for self care where it is safe to do so, providing greater choice and access for the public."