There is an increased risk of cardiovascular events in patients who take high doses of the anti-inflammatory ibuprofen, according to the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). The committee states that when taken at doses of 2400 mg/day or higher, there is a small increase in the risk of Myocardial Infarction and stroke. The risk is similar to the risk observed with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as COX-2 inhibitors and diclofenac.
Earlier, in different studies, researchers have shown that diclofenac, a drug used for pain and inflammation, increases the risk of cardiovascular events between 38% and 63%. The EMA too reached similar conclusions that diclofenac as compared with other NSAIDs presents a consistent but small increase in the risk of cardiovascular side effects.
However, the PRAC believes that the benefits of high-dose ibuprofen (2400 mg per day or higher) outweigh the small increased risk of cardiovascular events. Hence, it recommends that physicians should use caution when prescribing and avoid high-dose ibuprofen in select patients. They should assess patients’ risk factors for cardiovascular conditions and check for history of underlying heart or circulatory conditions, such as heart failure, heart disease, and circulatory problems, before starting them on long-term high-dose ibuprofen.
The PRAC states that the most commonly used over-the-counter dose of ibuprofen in the European Union, i.e. 1200 mg, poses no signal of harm. But, the recommendations of the committee do extend to high doses of dexibuprofen (1200 mg/day or more), which is similar to ibuprofen.
The recommendations of PRAC are going to be sent to the Coordination Group for Mutual Recognition for Decentralized Procedures—Human (CMDh). The CMDh will review the recommendations of PRAC and adopt a final position.
