The vaptans ante portas: a status report.

On 25 June 2008 the US Food and Drug Administration held a public Advisory Committee Meeting of its Cardiovascular and Renal Drugs Division on Tolvaptan (NDA 22-275), the first oral vasopressin antagonist to apply for licensing (http://www.fda.gov/ohrms/dockets/ac/cder08.html# CardiovascularRenal). Based on the comments made, we may now expect that tolvaptan will make it to the pharmacies soon. Over the last few years, we have been shown repeated evidence that vaptans shall be helpful (and safe) in the treatment of chronic hyponatraemia under most, though not all, circumstances [1,2]. Assuming that this scenario will come true, is it time to lean back and consider the issues surrounding the vaptans resolved? Not really.