FDA Investigation Of Potential Link Between Melanoma Skin Cancer And ED Drugs As Well BPH And PAH Medicines Continues
From this FDA watch list of drugs with possible safety issues, "January - March 2016: Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)", we learned that the US drug regulator is looking at the possible link between various drugs in the phosphodiesterase 5 (PDE-5) inhibitors class and melanoma as a side effect. The so-called "active ingredients" in the PDE5 class of drugs are sildenafil, tadalafil, vardenafil, and avanafil.
The five brand name erectile dysfunction (ED) drugs in the PDE-5 inhibitors class are Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Staxyn (vardenafil), and Stendra (avanafil).
Cialis is also prescribed sometimes when doctors see the signs and symptoms of benign prostatic hyperplasia (BPH).
Two other PDE-5 inhibitors, Revatio (sildenafil) and Adcirca (tadalafil), are prescribed for the treatment of pulmonary arterial hypertension (PAH).
To date, there has not been any status update from the FDA on their investigation about this possible malignant melanoma side effect of the PDE-5 drugs.
But during 2017 thus far, there have been a few medical journal articles published regarding the safety issue of whether drugs like Viagra and Cialis might cause or promote skin cancer, especially melanoma, which can be fatal.
We start with "Relation of phosphodiesterase type 5 inhibitors and malignant melanoma: a meta-analysis and systematic review", which was published online back in April 2017 and, later, in the July 11, 2017 edition of the Oncotarget journal.
Here is the Abstract for this article, which sets forth the findings of some medical researchers in China:
Data on the association between using PDE5 inhibitors and malignant melanoma are conflicting. To estimate the relation of using PDE5 inhibitors with risk of malignant melanoma, Medline (Ovid) and Embase (Ovid) databases were searched up to February 2017, and a random effects model was used to calculate the summary risk estimates. Five observational studies were included. Five studies reports encompassed a total of 15,979 melanoma cases occurring among 1, 188,414 participants. The pooled multivariable-adjusted RR of melanoma in patients with using PDE5 inhibitors was 1.12 (95% CI: 1.03–1.21, I2 = 0.48). Findings from this systematic review support that PDE5 inhibitor use is associated with increased risk of melanoma in ED patients, the result remains inclusive and warrants further study in the future.
Strictly Confidential, No Obligation.
Next is "Phosphodiesterase type 5 inhibitors and risk of melanoma: A meta-analysis", an article written by a set of five researchers affiliated with American and Chinese medical institutions. It was published by the Journal of the American Academy of Dermatology in September 2017.
Here are selected parts of the Abstract from this medical journal article:
- Background: The association between phosphodiesterase type 5 (PDE5) inhibitors and melanoma risk is controversial.
- Objective: We quantify the association between use of PDE5 inhibitors and melanoma.
- Results: Five observational studies were included. Compared with PDE5 inhibitor nonuse, PDE5 inhibitor use was slightly but significantly associated with an increased risk for development of melanoma (OR, 1.12; 95% CI, 1.03-1.21) and basal cell carcinoma (OR, 1.14; 95% CI, 1.09-1.19) but not squamous cell carcinoma. For melanoma risk, none of the prespecified factors (dose of PDE5 inhibitor, study design, and study region) significantly affected the results (P > .05). Our sensitivity analysis confirmed the stability of the results.
- Conclusions: Use of PDE5 inhibitors may be associated with a slightly increased risk for development of melanoma and basal cell carcinoma but not squamous cell carcinoma. However, further large well-conducted prospective studies with adequate adjustment for potential confounders are required for confirmation.
Last is this Review piece, "Update on the Safety of Phosphodiesterase Type 5 Inhibitors for the Treatment of Erectile Dysfunction", made available online by Sexual Medicine Reviews journal on October 12, 2017. It comes from two University of California researchers and one from University of Buenos Aires, in Argentina.
From this article's Abstract, here are two relevant points presented by these medical researchers:
- "There appears to be an association between [Phosphodiesterase type 5 inhibitors (PDE5Is)] use and melanoma but the absence of a mechanism of causation raises doubt that the association is cause and effect."; and,
- "Evidence on increased rates of melanoma and prostate cancer recurrence is weak and controversial."
Of course, we will continue to monitor the medical journals for additional research findings about malignant melanoma (perhaps more commonly called melanoma skin cancer) being linked to Viagra and Cialis as well as other PDE-5 drugs prescribed to treat erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH).
And we look forward to eventually hearing from the FDA concerning their investigation of this drug safety issue.
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (All website content by attorney Tom Lamb)
Drug Injury Case Evaluation - Free. Confidential. No Obligation. (Case review done by attorney Tom Lamb)