Saturday, January 10, 2009
statins
Statins May Cause Rare Instances of Eye Muscle Disorders
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By Michelle Rizzo
NEW YORK (Reuters Health) Jan 07 - Results of a study published in the December issue of Ophthalmology suggest that diplopia, ptosis, and ophthalmoplegia are associated with statin therapy at normal doses.
Because of "multiple reports of diplopia and ptosis associated with statin therapy" received at their institution, Drs. F. W. Fraunfelder and Amanda B. Richards, from the Casey Eye Institute, Oregon Health & Science University, Portland, investigated adverse events of this type.
They collected spontaneous reports from the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, and the Food and Drug Administration. A total of 256 case reports (143 males, 91 females, and 22 gender unspecified) of diplopia, ptosis, or ophthalmoplegia associated with statins were identified in the databases.
The median age of the patients was 69 years. The dosage varied between the different statin drugs, but the average dose was within the range recommended in the package insert for each medication. The average time to occurrence of the adverse drug reaction was 8 months.
Among the 256 case reports, "62 patients discontinued the statin and the diplopia or ptosis resolved," Dr. Fraunfelder told Reuters Health. "Sixteen case reports indicate that the statin was started again and the diplopia or ptosis reoccurred," he said. "This is positive rechallenge data and very compelling evidence that a real adverse drug reaction occurred with statins."
The side effect is rare, however. "It probably represents a localized myositis in the extraocular muscles just as statins can cause myositis in other skeletal muscles in the body," Dr. Fraunfelder noted. "Cardiologists or primary care doctors who prescribe medications in this class (statins) should be aware of this potential adverse drug reaction and consider stopping the drug if diplopia, ptosis, or ophthalmoplegia occur."
Ophthalmology 2008;115:2282-2285.
