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Frederick T Fraunfelder

Publications and source records attributed to Frederick T Fraunfelder.

8 recordsLinked to original sources
PubMed2006

Scientific challenges in postmarketing surveillance of ocular adverse drug reactions.

PURPOSE: To highlight the challenges of postmarketing surveillance for drug-related adverse events in the practice of ophthalmology. DESIGN: A retrospective review of the medical literature and postmarketing surveillance databases. METHODS: MEDLINE literature review of sildenafil-associated or amiodarone-associated optic neuropathy and chloramphenicol-associated blood dyscrasias. RESULTS: Sildenafil, amiodarone, and chloramphenicol may all cause adverse ocular events; however, the data are not conclusive. CONCLUSIONS: Reports in peer-reviewed medical journals may be proven incorrect over time. For drug-induced adverse ocular events, there is little true science after the drug reaches the marketplace, so the percentage of incorrect conclusions may be high. Clinicians should be wary of reports of adverse ocular effects until data are confirmed by multiple authors over the long-term. Even so, spontaneous reports from postmarketing surveillance databases may be the first and only signal of an adverse ocular event.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Isotretinoin-associated intracranial hypertension.

PURPOSE: To evaluate the association between intracranial hypertension (IH) and isotretinoin use. DESIGN: Observational case series. METHODS: In this retrospective study, approximately 1950 case reports of adverse ocular side effects related to isotretinoin were received from spontaneous reporting systems. Reports were evaluated as to the occurrence of IH with isotretinoin use. A survey was mailed to all members of the North American Neuro-ophthalmology Society soliciting their opinions on whether isotretinoin caused IH. RESULTS: One hundred seventy-nine reports of IH were associated with isotretinoin use. The mean time from drug exposure to IH diagnosis was 2.3 months. There were 6 cases of positive rechallenge; 5 new cases are reported here, along with 1 previously published report. Of neuro-ophthalmologists surveyed (62% response rate), 6% believed an association between IH and isotretinoin use was certain; 32%, probable; 52%, possible; and 10%, unlikely. Twelve respondents (4%) had personally seen one or more cases of positive rechallenge with isotretinoin causing IH. CONCLUSIONS: Based on the number and pattern of rapid IH onsets after isotretinoin exposure and the 6 cases of positive rechallenge, along with the probable similarity in metabolic pathways of this agent and vitamin A (a known cause of IH), it seems certain that there is a direct correlation between IH and isotretinoin use.

Adolescent↗
PubMed2004

Oculogyric crisis in patients taking cetirizine.

PURPOSE: To report oculogyric crisis in patients receiving cetirizine and inform clinicians on the characteristics of this drug-induced ocular side effect. METHODS: For this retrospective, observational case series, case reports were collected from the National Registry of Drug-Induced Ocular Side Effects (Casey Eye Institute, Portland, Oregon). The World Health Organization Causality Assessment Guide of Suspected Adverse Reactions was used to categorize the cases. RESULTS: Nine cases were reported, with eight occurring in the pediatric age group. Dosage ranged from 5 to 10 mg orally and onset of symptoms ranged from 3 to 184 days. Six cases of oculogyric crisis had positive rechallenge data. Eight cases had complete neurologic consultation including radiographic studies. CONCLUSIONS: Cetirizine can cause oculogyric crisis, especially in the pediatric age group. Extensive neurologic workups may be avoided if clinicians recognize this drug-induced ocular side effect.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Evidence for a probable causal relationship between tretinoin, acitretin, and etretinate and intracranial hypertension.

With the recognition that vitamin A and isotretinoin may cause intracranial hypertension, the authors reviewed 331 case reports of ocular side effects associated with the three other marketed retinoids: tretinoin, acitretin, and etretinate. The reports were drawn from the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization (WHO), the Food and Drug Administration, and medical journals between 1979 and 2003. There were 21 cases of intracranial hypertension associated with these three retinoids, leading to an inference that they are probably causally related to intracranial hypertension by WHO criteria. The lack of positive rechallenge data precludes the inference of a definite causal relationship to intracranial hypertension by WHO criteria. The inference of an independent causal role of these retinoids is further cautioned by the fact that six patients were concurrently using tetracycline or minocycline. Even so, the data suggest that all retinoids may, in rare instances, cause intracranial hypertension.

Acitretin↗
PubMed2003

Scleritis and other ocular side effects associated with pamidronate disodium.

PURPOSE: To evaluate reported cases of scleritis and other ocular side effects associated with pamidronate disodium, with emphasis on previously unreported cases of scleritis. DESIGN: Observational case series. METHODS: Case reports from the National Registry of Drug-Induced Ocular Side Effects (Casey Eye Institute), the Food and Drug Administration, the World Health Organization, and the literature were reviewed to determine possible adverse ocular side effects associated with pamidronate disodium. The World Health Organization's Causality Assessment Guide was used to categorize an adverse drug reaction. RESULTS: Seventeen cases of unilateral scleritis and one case of bilateral scleritis occurred, usually within 6 hours to 2 days after intravenous pamidronate disodium. Six patients had positive rechallenge testing with the scleritis occurring after a repeat drug exposure. Other ocular side effects with positive rechallenge data, associated with pamidronate disodium, include blurred vision, nonspecific conjunctivitis, ocular pain, bilateral anterior uveitis, and episcleritis. CONCLUSIONS: This is the first report, with rechallenge data, of any drug causing scleritis. Pamidronate disodium can cause vision-threatening diseases, which may require discontinuing the drug in some uveitis cases and, in this series, all cases of scleritis.

Aged↗
PubMed2002

Adverse systemic effects from pledgets of topical ocular phenylephrine 10%.

PURPOSE: To report 11 cases of adverse systemic reactions to topical ocular application of phenylephrine 10% in pledget form and to discourage this method of treatment for hemostasis in laser assisted in-situ keratomileusis (LASIK) surgery and other ophthalmic uses. DESIGN: Observational case series. METHODS: The literature, reports provided to the spontaneous reporting system of the United States Food and Drug Administration and the National Registry of Drug-Induced Ocular Side Effects (Casey Eye Institute, Portland, Oregon) were reviewed. Age, sex, duration of therapy, other drugs the patient was taking, and systemic reactions are provided in the series of 11 cases with adverse systemic reactions. RESULTS: Eleven cases of adverse systemic reactions to topical ocular phenylephrine 10% applied in pledget form occurred in 8 male and 3 female patients with an age range from 1 to 76 years. All cases occurred after a single exposure, most patients noted systemic effects within minutes of phenylephrine application, and the adverse systemic reactions included severe hypertension, pulmonary edema, cardiac arrhythmia, cardiac arrest, and subarachnoid hemorrhage. CONCLUSIONS: We recommend ophthalmologists not use this method of phenylephrine application and believe it is contraindicated in ophthalmic surgery, especially when other medications may be used.

Adult↗