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FDA Drug Safety Communication: Ongoing safety review of the angiotensin receptor blockers and cancer

  

Safety Announcement

Additional Information for Patients

Additional Information for Healthcare Professionals

Data Summary

Approved Angiotensin Receptor Blockers

 

Safety Announcement 

[7-15-2010] The U.S. Food and Drug Administration (FDA) is conducting a review of the class of medications known as angiotensin receptor blockers (ARBs) after a recently published study suggested they may be associated with a small increased risk of cancer.

  • FDA's review is ongoing and the Agency has not concluded that ARBs increase the risk of cancer.
  • At this time, FDA believes that the benefits of these medicines continue to outweigh their potential risks.
  • FDA recommends that these drugs continue to be used as recommended in their approved labels.

ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. ARBs are also sold in combination with other medications (see Approved Angiotensin Receptor Blockers below).

The Agency plans to review the available data on these medications, and evaluate additional ways to better assess a possible link between use of ARBs and cancer. FDA will update the public when this review is complete.

The published study was a meta-analysis combining cancer-related findings from several clinical trials. The study found a small increased risk of reported new cancers in patients taking an ARB compared to those not taking an ARB.1 No statistically significant difference in the number of cancer deaths was observed (see Data Summary below).

These clinical trials were not designed to study the effects of ARBs on cancer risk. The findings need close examination for more detailed information about the patients who were reported to have cancer so that it can be determined whether this cancer was in fact new. ARBs have been shown to provide significant benefit in many patients with certain heart-related conditions such as high-blood pressure and heart failure.

 

Additional Information for Patients

  • FDA has not concluded that angiotensin receptor blockers (ARBs) increase the risk of cancer. FDA is evaluating this safety concern and will update the public when additional information is available.
  • FDA believes the benefits of ARBs in patients with high blood pressure and certain heart-related conditions continue to outweigh their potential risks.
  • Do not stop taking your ARB unless told to do so by your healthcare professional.
  • Talk to your healthcare professional if you have concerns about your medicine.
  • Report any side effects you 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 

  • The meta-analysis by Sipahi et al. concluded that there was an increase in new cancer diagnoses in patients randomized to an ARB.1
  • FDA has not concluded that angiotensin receptor blockers (ARBs) increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available.
  • FDA believes the benefits of ARBs continue to outweigh their potential risks.
  • Report adverse events involving ARBs to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.

 

Data Summary

The meta-analysis included data from over 60,000 patients in several long-term, randomized, controlled clinical trials evaluating angiotensin receptor blockers (ARBs) for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years.

The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.

The meta-analysis had several limitations that make it difficult to determine the validity of the findings without further examination of the underlying data. The limitations include:

  • The analysis included data from trials where there was no adjudication of cancer-related adverse events. In these trials, there was no way to determine whether the events represented new diagnoses of cancer, or events related to a preexisting cancer. Thus, the actual number of new cancer occurrences is unknown.
  • The analysis may not have included all relevant clinical trials of ARBs.
  • The analysis is not based on patient-level data. Knowledge of the specific timing and nature of events in individual patients would aid in interpretation of the findings.
  • The majority of patients included in the studies reviewed were receiving the ARB telmisartan; therefore the applicability of the cancer-related findings to all ARBs is uncertain.
  • The meta-analysis was planned to examine a hypothesis raised by cancer-related trends in three outcome studies. Because the meta-analysis included two of these studies, the results of the meta-analysis do not provide a fully independent confirmation of the hypothesis raised by the earlier studies.

Once complete, FDA's review will provide additional information about the possible link between ARB use and development of cancer. At this time, FDA recommends that healthcare professionals continue to use ARBs as recommended in their product labels. Patients should not stop taking their medication unless told to do so by their healthcare professional.

 

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 Names

 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 Oncolology 2010;11(7), 627-36.

 

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