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drug adverse effects of phosphodiesterase-5-inhibitors

Adverse effects: 1) adverse ocular effects a) blurred vision b) cataracts c) changes in color perception d) conjunctivitis e) dry eyes f) eye hemorrhage g) eye pain h) mydriasis i) small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy) Viagra, Cialis & Levitra specifically implicated. [1] j) risk for serous retinal detachment & retinal vascular occlusion [6] - no adverse visual or retinal effects associated with daily administration of tadalafil or sildenafil for 6 months [3] - absolute risk is low [6] 2) reports of sudden hearing loss [2], generally unilateral, sometimes persistent, tinnitus may be associated 3) headache [4] 4) flushing [4] 5) dyspepsia [4] 6) rhinitis [4] 7) back pain/myalgias (tadalafil, others ?) [4] 8) increased risk of cutaneous melanoma [2] (RR=1.21)* 9) increased risk of basal cell carcinoma (BCC) [2] (RR=1.19)* * downregulation of PDE5 is thought to increase invasiveness of melanoma; however, risk > for stages 0 & 1 but not stages 2-4 & no dose-response effect * no plausible mechanism for increased risk of BCC

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DRUGS: phosphodiesterase-5 inhibitor FORM: drug adverse effects phosphodiesterase 5 inhibitor

References

  1. http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#ED
  2. Prescriber's Letter 14(12): 2007 Sudden hearing loss with Viagra, Levitra, Cialis, and Revatio Detail-Document#: 231204 (subscription needed) http://www.prescribersletter.com
  3. Cordell WH et al, Retinal Effects of 6 Months of Daily Use of Tadalafil or Sildenafil Archives of Ophthalmology 2009;127(4):367-373 PMID: 19365010
  4. Medical Knowledge Self Assessment Program (MKSAP) 15, American College of Physicians, Philadelphia 2009
  5. Schwenk TL Association Between Erectile Dysfunction Drugs and Malignant Melanoma NEJM Journal Watch. June 23, 2015 Massachusetts Medical Society (subscription needed) http://www.jwatch.org - Loeb S et al. Use of phosphodiesterase type 5 inhibitors for erectile dysfunction and risk of malignant melanoma. JAMA 2015 Jun 23; 313:2449 PMID: 26103029
  6. Etminan M, Sodhi M, Mikelberg FS et al Risk of Ocular Adverse Events Associated With Use of Phosphodiesterase 5 Inhibitors in Men in the US. JAMA Ophthalmol. Published online April 7, 2022. PMID: 35389459 https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2790661