Amlodipine and Cancer Risk
Based on the available evidence, amlodipine is not associated with an increased risk of cancer and can be safely used in patients requiring calcium channel blocker therapy for hypertension. 1
Safety Profile of Amlodipine Regarding Cancer Risk
FDA-Approved Drug Information
The FDA drug label for amlodipine specifically addresses carcinogenicity concerns, stating that rats and mice treated with amlodipine maleate in the diet for up to two years showed no evidence of carcinogenic effects, even at doses up to 2.5 mg/kg/day 1. This preclinical safety data provides strong reassurance regarding the lack of carcinogenic potential.
Guideline Recommendations
Multiple cardiovascular guidelines support the safety of amlodipine:
- The American Heart Association (AHA) specifically mentions that amlodipine appeared to be safe in patients with severe systolic heart failure in the PRAISE trial 2.
- The 2016 AHA scientific statement on comorbidities in chronic heart failure identifies amlodipine as one of the few calcium channel blockers that can be safely used in heart failure patients 2.
- European guidelines also support amlodipine's safety profile, noting its use in comparative trials without raising cancer-related concerns 2.
Clinical Evidence
The Prospective Randomized Amlodipine Survival Evaluation (PRAISE) trial demonstrated that amlodipine did not increase cardiovascular morbidity or mortality in patients with severe heart failure 3. While this study didn't specifically examine cancer outcomes, it supports the overall safety profile of amlodipine in high-risk patients.
Cancer-Related Research on Calcium Channel Blockers
Recent Research
Some recent studies have actually suggested potential anticancer properties of amlodipine:
- A 2022 study found that amlodipine demonstrated anticancer effects in non-small cell lung cancer, suggesting it might inhibit cancer cell proliferation by arresting the tumor cell cycle 4.
- Another 2022 study reported that amlodipine improved outcomes when used alongside regorafenib in metastatic colorectal cancer patients 5.
Meta-Analysis Findings
A 2018 meta-analysis examining anti-hypertensive drugs and skin cancer risk did find that calcium channel blocker (CCB) users as a class had a slightly increased skin cancer risk (SRR 1.14,95% CI 1.07-1.21) 6. However:
- This finding was for the entire class of CCBs, not specific to amlodipine
- The increased risk was modest (14%)
- The study did not establish causality
- This finding has not been incorporated into major cardiovascular guidelines
Clinical Application
When prescribing amlodipine, consider:
- Amlodipine is one of the few calcium channel blockers specifically mentioned as safe in patients with heart failure 2
- For patients with hypertension and heart failure, amlodipine can be used when other first-line agents (ACE inhibitors, ARBs, beta-blockers) are insufficient or contraindicated
- Regular skin examinations may be prudent for patients on long-term calcium channel blocker therapy, though this is not a specific recommendation for amlodipine alone
Common Pitfalls to Avoid
- Don't confuse the safety profile of amlodipine with non-dihydropyridine calcium channel blockers (diltiazem, verapamil), which have different safety concerns
- Don't withhold amlodipine therapy when clinically indicated due to unfounded cancer concerns
- Don't assume that findings from meta-analyses of entire drug classes necessarily apply to individual medications within that class
In conclusion, the available evidence, particularly the FDA drug label and major cardiovascular guidelines, supports that amlodipine does not have a clinically significant association with increased cancer risk and can be safely prescribed for appropriate indications.