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Ocular safety of Viagra, (sildenafil citrate).
Trans Am Ophthalmol Soc. 1999; 97:115-25; discussion 125-8.TA

Abstract

To date, sildenafil citrate (Viagra) gives every evidence of being a safe drug for the eye despite a series of expressed concerns. A review of how its ocular safety profile has been identified offers insights into the strengths and weaknesses of present systems and resources for judging the ocular safety of Viagra or, for that matter, of any new drug. Such insights include: The great value of careful, informed assessment of preclinical information gleaned from laboratory experiments. By and large, such assessments point the way toward appropriate clinical evaluation. For Viagra, early in its development it was noted that besides exerting a major inhibitory effect on the intended target, the vascular-associated enzyme phosphodiesterase 5 (PDE5), the drug also exerts a lesser but definite inhibitory effect on the closely related PDE6, located in the retina. For this reason, preclinical evaluation of the drug included electroretinography plus postmortem histology. In addition, an extended eye examination was incorporated into clinical protocols. The often chaotic but invaluable information stream that becomes available once marketing approval has been gained and large populations begin to use a drug. False alarms, misattribution, and erroneous information are the order of the day. Nevertheless, as information accumulates, patterns of response clarify and the true nature of special susceptibility for subpopulations, if any, becomes apparent. A role for the astute clinician remains: Subtle changes or unusual risks for subpopulations can be missed entirely for long periods of time. A manifest need for improvement in evaluation of postmarketing side-effects. This need has led to the establishment of a new discipline: pharmacoepidemiology. In ophthalmology, the National Registry of Drug Induced Ocular Side-Effects maintains a constant and invaluable surveillance. Examples are supplied to illustrate each of these major points: Our presentation will include data gleaned from clinical trials plus postmarketing information on the incidence, duration, and type of color vision defects observed at different doses of Viagra.

Authors+Show Affiliations

Scheie Eye Institute, Philadelphia, USA.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

10703120

Citation

Laties, A M., and F T. Fraunfelder. "Ocular Safety of Viagra, (sildenafil Citrate)." Transactions of the American Ophthalmological Society, vol. 97, 1999, pp. 115-25; discussion 125-8.
Laties AM, Fraunfelder FT. Ocular safety of Viagra, (sildenafil citrate). Trans Am Ophthalmol Soc. 1999;97:115-25; discussion 125-8.
Laties, A. M., & Fraunfelder, F. T. (1999). Ocular safety of Viagra, (sildenafil citrate). Transactions of the American Ophthalmological Society, 97, 115-25; discussion 125-8.
Laties AM, Fraunfelder FT. Ocular Safety of Viagra, (sildenafil Citrate). Trans Am Ophthalmol Soc. 1999;97:115-25; discussion 125-8. PubMed PMID: 10703120.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ocular safety of Viagra, (sildenafil citrate). AU - Laties,A M, AU - Fraunfelder,F T, PY - 2000/3/7/pubmed PY - 2000/3/25/medline PY - 2000/3/7/entrez SP - 115-25; discussion 125-8 JF - Transactions of the American Ophthalmological Society JO - Trans Am Ophthalmol Soc VL - 97 N2 - To date, sildenafil citrate (Viagra) gives every evidence of being a safe drug for the eye despite a series of expressed concerns. A review of how its ocular safety profile has been identified offers insights into the strengths and weaknesses of present systems and resources for judging the ocular safety of Viagra or, for that matter, of any new drug. Such insights include: The great value of careful, informed assessment of preclinical information gleaned from laboratory experiments. By and large, such assessments point the way toward appropriate clinical evaluation. For Viagra, early in its development it was noted that besides exerting a major inhibitory effect on the intended target, the vascular-associated enzyme phosphodiesterase 5 (PDE5), the drug also exerts a lesser but definite inhibitory effect on the closely related PDE6, located in the retina. For this reason, preclinical evaluation of the drug included electroretinography plus postmortem histology. In addition, an extended eye examination was incorporated into clinical protocols. The often chaotic but invaluable information stream that becomes available once marketing approval has been gained and large populations begin to use a drug. False alarms, misattribution, and erroneous information are the order of the day. Nevertheless, as information accumulates, patterns of response clarify and the true nature of special susceptibility for subpopulations, if any, becomes apparent. A role for the astute clinician remains: Subtle changes or unusual risks for subpopulations can be missed entirely for long periods of time. A manifest need for improvement in evaluation of postmarketing side-effects. This need has led to the establishment of a new discipline: pharmacoepidemiology. In ophthalmology, the National Registry of Drug Induced Ocular Side-Effects maintains a constant and invaluable surveillance. Examples are supplied to illustrate each of these major points: Our presentation will include data gleaned from clinical trials plus postmarketing information on the incidence, duration, and type of color vision defects observed at different doses of Viagra. SN - 0065-9533 UR - https://www.unboundmedicine.com/medline/citation/10703120/Ocular_safety_of_Viagra__sildenafil_citrate__ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/10703120/ DB - PRIME DP - Unbound Medicine ER -