Translated from Rev Prescrire December 2009; 29 (314): 905-906

Telithromycin: visual disorders

G Telithromycin is a macrolide antibi- during clinical trials of telithromycin (1-4). diplopia occurred in about half of the otic with a negative risk-benefit bal- A Finnish review of pharmacovigilance cases linked to telithromycin (5). ance. Its efficacy is no better than that reports published in 2009 examined the of other macrolides. Telithromycin car- frequency, characteristics and reversibil- Ciliary body dysfunction? Ophthal- ries a risk of serious adverse effects, ity of these ocular adverse effects (5). mological findings were normal in patients including loss of consciousness, QT with visual disorders due to telithromycin (3). prolongation, severe liver damage, A Finnish review: generally reversi- The underlying mechanism is not entire- aggravation of myasthenia gravis, and ble visual disorders. The Finnish drug ly clear. One possibility is a reversible a high risk of drug interactions. regulatory agency has published a effect of telithromycin on the ciliary body, 7-year review of pharmacovigilance delaying ciliary muscle relaxation and G In Finland, a 7-year pharmacovigi- reports concerning telithromycin since thus affecting accommodation (6). lance review identified 20 reports of its market introduction in 2002. It mentions visual disorders among patients taking 20 reports of visual disorders out of a total In practice. Telithromycin is sometimes telithromycin, including blurred vision, of 52 reports involving telithromycin (5). associated with visual disorders. Even if they accommodation disorder and diplopia, Most of the patients were young (20 to are usually moderate and transient, they mainly in young patients and women. 40 years) and female (16 cases). can be troubling and may make driving or Eight patients had blurred vision and 6 operating heavy machinery dangerous (7). G Visual disorders occurred in about had miscellaneous visual disorders includ- This is yet another reason to avoid 1% of patients receiving telithromycin ing loss of near or distant visual acuity, using telithromycin, a drug with a clearly in clinical trials. They were generally image distortion, and visual field disor- unfavourable risk-benefit balance (1). moderate, brief and reversible. ders. Diplopia, ocular pain and oculo- It is time for the regulatory agencies or gyric episodes were occasionally report- the manufacturer to withdraw telithromycin G These visual disorders may result ed, sometimes associated with general from the market. from reversible paralysis of the ciliary symptoms such as headache, nausea, ©Prescrire body due to telithromycin. malaise, and dizziness (5). In 15 cases the visual disorders occurred a- In 2006 and 2007, certain indications were restricted G In practice, these visual disorders, within 24 hours after treatment initiation. to second-line use due to numerous adverse effects (ref 8). The licensed indications of telithromycin are worded as fol- which can be dangerous when driving or Outcome was known in 12 cases and was lows in the EU summary of product characteristics: “In operating heavy machinery, add to the generally favourable. Four patients had patients of 18 years and older: -Community-acquired pneumonia, mild or moderate already long list of adverse effects of not yet recovered normal vision when the -When treating infections caused by known or suspected telithromycin. They are yet another rea- disorder was reported. The doses of beta-lactam and/or macrolide resistance (…): acute exac- son not to use telithromycin, but rather telithromycin are not specified in this review. erbation of chronic bronchitis, acute sinusitis. spiramycin In patients of 12 years and older: a safer macrolide such . -Tonsillitis/pharyngitis caused by Streptococcus pyogenes, Rev Prescrire 2009; 29 (314): 905-906. Visual disorders in 1% of patients. In as an alternative when beta-lactam antibiotics are not clinical trials, reversible visual disorders appropriate in countries/regions with a significant preva- telithromycin lence of macrolide resistant S. pyogenes (…)” (ref 7). were more frequent with than b- The European SPC was modified in 2007 to recommend elithromycin is a macrolide antibiot- with comparator antibiotics (5,6). Accord- taking the drug at bedtime, in order to reduce the potential T ic (a)(1-3). There is no evidence that ing to the US Food and Drug Administra- impact of visual disorders and loss of consciousness (ref 8). it is more effective than other macrolides, tion (FDA), visual disorders occurred in regardless of the bacterial species 0.7% of patients taking telithromycin (5). Selected references from Prescrire’s literature involved (1). Telithromycin shares the The European Medicines Agency (EMA) search. 1- Prescrire Editorial Staff “Telithromycin” Prescrire adverse effects of all macrolides, mainly estimated that 1.1% of patients treated Int 2003; 12 (63): 8-12. including gastrointestinal disorders (diar- with telithromycin experienced visual dis- 2- Prescrire Rédaction “16-1-8. Patients sous macrolide” Rev Prescrire 2009; 29 (314 suppl. inter- rhoea, nausea and vomiting, abdominal orders, versus 0.4% of patients in com- actions médicamenteuses). pain and dyspepsia) and neurological parator groups (6). Blurred vision, other 3- “Telithromycin”. In: “Martindale The Complete disorders (headache and dizziness). It unspecified visual disorders, and abnormal Drug Reference” The Pharmaceutical Press, Lon- don. www.medicinescomplete.com accessed can also prolong the QT interval when accommodation were reported (1). 12 June 2009: 6 pages. used at the standard oral doses, and also Between April 2004 and July 2006, 4- Prescrire Editorial Staff “Telithromycin: visual provoke severe liver damage, aggravate FDA recorded 390 cases of visual disor- disorders, myasthenia” Prescrire Int 2008; 17 (94): 67. 5- Vuorio A and Rajaratnam R “Telithromycin and myasthenia gravis, as well as cause loss ders associated with telithromycin, 71 of visual disturbances” TABU 2009; 17 (2): 44-46. of consciousness (1-4). In addition, like which were serious (b)(4). 6- EMA - CHMP “European Public Assessment spi- Report - Ketek (revision 13) - Scientific discussion” other macrolides, with the exception of The Finnish review mentions a study 29 pages; posted on EMEA website 9 June 2009. ramycin, telithromycin can interact with based on an Italian register of visual 7- Commission européenne “Résumé des caractéris- many other drugs, with potentially serious adverse effects attributed to macrolides. tiques du produit - Ketek” 2 June 2009: 14 pages. 8- Prescrire Rédaction “Télithromycine: trop de clinical consequences (1-3). Nearly half of the reports involved risques graves, mais des agences frileuses” Rev Visual disorders were first observed telithromycin and blurred vision and/or Prescrire 2007; 27 (283): 347.

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