A large-scale study of more than 6.3 million adults, has found that over-the-counter painkiller, diclofenac, sold in America as Volatren and Solaraze among others may increase your risk of heart attack or stroke by 50 percent.

The drug, according to the study, also puts patients at higher risks of gastrointestinal bleeding than those on other painkillers.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), used to relieve fever or toothache in adults, or severe joint pain in children. Heart concerns led to British regulators banning the drug over-the-counter in 2015, but the authors of the new study, published on Wednesday in the British Medical Journal, are now calling for global action to protect patients.

The research team from Aarhus University Hospital in Denmark says it is time to acknowledge the potential health risk of diclofenac and reduce its use, adding, “Dicofenac should not be available over the counter, and when prescribed should be accompanied by an appropriate front package warning about its potential risks.”

For the study, the team, led by Morten Schmidt, PhD, analyzed national registry data for over 6.3 million Danish adults.

All of these patients had been taking prescription medications for at least a year before the study began in January 1996.