Novartis to revamp Rasilez label with safety risks

The data on Rasilez's safety risks is coming home to roost. The Novartis ($NVS) blood-pressure drug will get a new warning in Europe at regulators' request, after a recent trial flagged links to stroke and kidney problems.

The Swiss drugmaker will revise the drug's European label to say that Rasilez should not be used in patients with diabetes or kidney problems who are also using ACE inhibitors or angiotensin receptor blockers. Like Rasilez, ACE inhibitors and ARBs are used to treat high blood pressure.

"In addition, the agency recommended the inclusion of a warning that the combination of aliskiren and ACE inhibitor or ARB is not recommended in all other patients because adverse outcomes cannot be excluded," the EMA's Committee for Medicinal Products for Human Use said (as quoted by Reuters).

Novartis also said it has written doctors around the world recommending against using Rasilez--which is sold in the U.S. as Tekturna--in patients with Type 2 diabetes if they're also receiving an ACE inhibitor or ARB. The company is also working with the FDA on guidelines for use of the drug.

Novartis stopped a Rasilez/Tekturna trial in December after data suggested it might boost the risk of stroke and kidney problems. Since then, the company has downgraded its long-term expectations for the drug and taken a $900 million charge related to that lower forecast, Bloomberg notes. Novartis now says 2012 sales will be less than half of the $557 million posted last year. The company had been hoping the products would help fill the gap left when its older blood-pressure remedy Diovan goes off patent later this year.

- find the release from Novartis
- read the Bloomberg story
- get more from Reuters
- see The Wall Street Journal's take