European watchdog seeks tighter guidelines on ibuprofen
A European panel on Monday backed tougher guidelines on ibuprofen after research found high doses of the popular painkiller were linked to a small increase in cardiac and stroke risk.
Daily doses of 2,400 milligrams or higher "should be avoided in patients with serious underlying heart or circulatory conditions," the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) said.
PRAC's review of published research found "a small increase" in risk, on a scale similar to that seen with other so-called non-steroidal anti-inflammatory drugs.
Doctors should carefully assess a patient's risk profile for heart or circulatory problems before starting long-term, high-dose ibuprofen, EMA said in a press release.
The usual dose for adults and children over 12 years is 200 to 400 mg, three or four times a day. No risk was seen at this dosage, EMA said.
Recommendations by the PRAC have to be endorsed by a pan-European coordinating committee before they are incorporated into guidelines by national agencies.
