EMA Issues Drug Safety Reminders

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) met on May 10–12, 2023 to review medicines containing hydroxyprogesterone due to safety and effectiveness concerns. Hydroxyprogesterone caproate is available in the European Union and is given by injection to prevent pregnancy loss or premature birth. These medicines are also given in some countries to treat various gynecological disorders, according to the agency.

The French medicines agency requested PRAC review the medicines after a study suggested patients exposed to the drugs may have an increased risk of cancer that would increase when the drug was used in the first trimester of pregnancy and with the number of injections.

PRAC also issued a reminder about the risks associated with the use of fluoroquinolone antibiotics and said they should not be used to treat infections that might get better without treatment or to treat non-bacterial infections or mild bacterial infections. The restrictions imposed on these medicines were a result of a study that showed the risk of disabling, long-lasting side effects.