What You Need to Know About Diovan
What is Diovan? What does it do?
Diovan is sold in the United States by Novartis. It is prescribed to treat high blood pressure in adults1 and to treat hypertension in adults and children older than 6 years, for patients suffering heart failure and to treat patients following a heart attack.2
Diovan is a brand name of valsartan. Valsartan is part of a group of drugs, called angiotensin receptor blockers, which regulate blood pressure by dilating blood vessels and suppressing hormones that cause the body to retain liquid and reabsorb water in the kidneys.3
Does Diovan work?
A review of seven studies sponsored by Diovan’s maker, Novartis, reported that studies found that Diovan was effective in reducing blood pressure.4
The FDA wrote to Novartis in 2004 regarding a claim by a sales aid prepared by the company that made an unproven claim that Diovan was effective in preserving kidney function in patients with type 2 diabetes. The letter stated that there was no evidence of this claim and that, contrary to the sales aid’s claims, other drugs of the same type as Diovan had been found to reduce kidney function in patients suffering from type 2 diabetes.5
What should I go over with my doctor before I decide to take Diovan?
Diovan can cause severe fetal harm and even fetal death when taken during pregnancy. If you’re pregnant and considering Diovan or become pregnant while taking Diovan, talk to your doctor.6
The FDA warns that Diovan can cause impaired kidney function, hyperkalemia (elevated levels of potassium in the blood which can lead to fatally abnormal heart rhythms), heart failure, kidney failure and impaired kidney function, angiodema (swelling of face, lips, tongue or throat) and rare reports of hepatitis and elevated liver enzymes, thrombocytopenia (decrease in blood platelets), vasculitis (inflammation of blood vessels) and alopecia (loss of head and body hair).7
What if I’m already taking Diovan?
Never stop taking any prescription drug without speaking to your doctor. If you have experienced adverse symptoms or side effects or are concerned about Diovan, talk to your doctor.
Learn everything you can about Diovan before you start taking it.
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1 http://www.diovan.com/
2 Food and Drug Administration, Diovan Highlights of Prescribing Information, (November 2007) http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM166800.pdf
3 Mayo Clinic, “Valsartan and Hydrochlorothiazide” (Updated 1 September 2012, retrieved 20 October 2012), http://www.mayoclinic.com/health/drug-information/DR600427
4 Vasc Health Risk Manag, Abraham I. et al, “Real-world effectiveness of valsartan on hypertension and total cardiovascular risk: review and implications of a translational research program” (31 March 2011), http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3072745/
5 Food and Drug Administration, Warning Letter, (21 April 2004) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055309.pdf
6 Food and Drug Administration, Diovan Labeling Information, http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf
7 Food and Drug Administration, Safety Information Diovan, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm262225.htm; Food and Drug Administration, Highlights of Prescribing Information (retrieved 20 October 2012), http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021283s033lbl.pdf