European regulatory authorities on Thursday said an Abbott Laboratories (ABT) diet pill should be banned from sale in the market, issuing tougher warnings for the drug because the drug poses high risks of stroke and heart attack.
The warning was conveyed after a study of 10,000 patients suggested it put them at a higher risk for heart disease.
The study revealed 11.4% of those who used Meridia as a medication faced a cardiovascular event such as a heart attack, compared with 10% of patients who received a fake pill.
This medicine is sold in Europe under the brand-names Reductil, Reduxade, Zelium and other names; and as Meridia in the U. S.
The warning for not to use Meridia is to include patients with a history of problems as Coronary artery disease, heart attack, transient ischemic attack, Arrhythmia, Congestive heart failure, Peripheral arterial disease, uncontrolled hypertension.
The agency's decision will now get passed to the European Commission for review.
The FDA said Abbott has agreed to update the label bearing “recommended the drug shouldn't be used in patients with a history of heart disease, “and further plans to convene an advisory committee meeting to further discuss the safety and risks with Meridia.