The European Medicines Agency said it would review the use of aliskiren-containing medicines after blood pressure drug Rasilez made by Novartis was shown in an independent study to increase the risk to patients with heart or kidney problems.
The regulator said on Thursday it would assess data from the ALTITUDE study, which was terminated early after patients showed no benefit from using the drug.
There were more cases of stroke, renal complications, hyperkalemia and hypotension in patients who received aliskiren compared with patients who received a placebo.
Novartis was not immediately available to comment on Thursday.
On Tuesday, the company said it was recommending the removal from patients' treatment of products based on aliskiren, which it markets as Rasilev in Europe and Tekturna in the United States, and a review of their high blood pressure medication.
Eight medicines containing aliskiren, a type of renin inhibitor, are licensed for use in Europe.
(Reporting by Paul Sandle; Additional reporting by Martin de Sa'Pinto; Editing by Erica Billingham)