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FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)

This information is an update to the FDA Drug Safety Communication: Ongoing safety review of the angiotensin receptor blockers and cancer issued on July 15, 2010.

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary

Safety Announcement

[06-02-2011] The U.S. Food and Drug Administration (FDA) has completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers (ARBs). FDA has concluded that treatment with an ARB medication does not increase a patient’s risk of developing cancer. A list of medications containing an ARB is available here.

Facts about Angiotensin Receptor Blockers (ARBs)

  • ARBs are widely used to treat patients with high blood pressure.  
  • Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten, as well as the combination product brand names included in Table 1 below.

In July 2010, FDA communicated its intent to conduct a safety review of ARBs after a published meta-analysis of 5 randomized clinical trials reported a small but statistically significant increase in risk of cancer in patients taking an ARB compared to patients not taking an ARB.1

To further evaluate the reported link between use of ARBs and cancer, FDA conducted a trial-level meta-analysis of clinical trials in which patients had been randomized to an ARB treatment or a non-ARB treatment. This analysis included 31 trials and approximately 156,000 patients, far more than the approximately 62,000 in the published analysis. FDA’s more comprehensive meta-analysis did not show an increased risk of cancer in the patients taking an ARB medication.

Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer.

Additional Information for Patients

  • Do not stop taking your ARB medication without talking to your healthcare professional.
  • Discuss any questions or concerns about ARB medications with your healthcare professional.
  • Report any side effects you may experience to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of the page.

Additional Information for Healthcare Professionals

  • Know that FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs.
  • Report adverse events involving ARB medications to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Data Summary

FDA conducted a trial-level meta-analysis of 31 randomized clinical trials to evaluate the risk of incident (new) cancer in patients taking ARBs compared to patients taking non-ARB treatments. The meta-analysis also evaluated the associations between ARBs and the following outcomes individually: cancer-related death, breast cancer, lung cancer, and prostate cancer.

The FDA study is the largest meta-analysis of clinical trials exploring the association between ARBs and cancer conducted to date. The analysis included all drug sponsor-identified randomized clinical trials that met pre-specified criteria (trials that included more than 100 patients and lasted for at least 1 year), including ascertainment of the occurrence of cancer or cancer death as a pre-specified endpoint or adverse event.  

The 31 trials included 84,461 patients randomized to ARBs and 71,355 patients randomized to non-ARB comparators, with an average follow-up of 39 months. The rate of incident cancer events in the ARB group was 1.82 per 100 patient-years, and the rate in non-ARB comparators was 1.84 per 100 patient-years. The relative risk of incident cancer in patients taking ARBs was 0.99 (95% confidence interval 0.92 to 1.06).  The estimate of risk was similar irrespective of the choice of statistical method (random effects or fixed effects), as well as the choice of comparator arm used in the analysis (all comparators, placebo only, active-comparators only).

FDA also found no evidence of association between ARBs and cancer-related death (relative risk 1.04, 95% confidence interval 0.96 to 1.13), breast cancer (odds ratio 1.06, 95% confidence interval 0.90 to 1.23), lung cancer (odds ratio 1.07, 95% confidence interval 0.89 to 1.29), or prostate cancer (odds ratio 1.05, 95% confidence interval 0.95 to 1.17).

The results from three recently published studies (two meta-analyses2,3 generally similar to the FDA analysis and an observational cohort study4) also do not suggest any increased risk of cancer related to ARB use.

Table 1. Approved Angiotensin Receptor Blockers

Single Ingredient Angiotensin Receptor Blockers

Brand name

Generic name

Atacand

candesartan

Avapro

irbesartan

Benicar

olmesartan

Cozaar

losartan

Diovan

valsartan

Micardis

telmisartan

Teveten

eprosartan

Combination Angiotensin Receptor Blockers

Brand name

Generic name

Atacand HCT

candesartan and hydrochlorothiazide

Avalide

irbesartan and hydrochlorothiazide

Azor

olmesartan and amlodipine

Benicar HCT

olmesartan and hydrochlorothiazide

Diovan HCT

valsartan and hydrochlorothiazide

Exforge

valsartan and amlodipine

Exforge HCT

valsartan, amlodipine, and hydrochlorothiazide

Hyzaar

losartan and hydrochlorothiazide

Micardis HCT

telmisartan and hydrochlorothiazide

Teveten HCT

eprosartan and hydrochlorothiazide

Twynsta

telmisartan and amlodipine

Valturna

valsartan and aliskiren

References

  1. Sipahi I, Debanne SM, Rowland DY, Simon DI, Fang JC. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. The Lancet Oncology 2010;11: 627-36.
  2. Bangalore S, Kumar S, Kjeldsen SE, et al. Antihypertensive drugs and risk of cancer: network meta-analyses and trial sequential analyses of 324,168 participants from randomized trials. Lancet Oncol 2011;12: 65-82.
  3. The ARB Trialists Collaboration. Effects of telmisartan, irbesartan, valsartan, and candesartan, and losartan on cancers in 15 trials. J Hypertens 2011;29: 623-635.
  4. Pasternak B, Svanström H, Callréus T, et al. Use of angiotensin receptor blockers and the risk of cancer. Circulation 2011;123: 1729-36.

 

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