In conjunction with EU regulatory authorities, including the MHRA, Cephalon has informed Healthcare Professional of the following new warnings and safety information for Provigil ( Modafinil ) regarding serious skin rash and psychiatric symptoms which have been provided to the MHRA in order to update the UK Provigil SmPC.

Summary of the safety concern

• Serious skin rashes requiring hospitalization and discontinuation of treatment have been reported in adults and children in association with the use of Modafinil occurring within 1 to 5 weeks after treatment initiation [ isolated cases have been reported after prolonged treatment ( e.g. 3 months ) ]. Modafinil should be discontinued at the first sign of rash and not restarted unless the rash is clearly not drug-related.

• Psychiatric adverse experiences ( psychosis, mania, delusion, hallucinations, suicidal ideation and aggression ) have been reported in patients treated with Modafinil. If psychiatric symptoms occur, Modafinil should be discontinued and not restarted. Caution should be exercised when administering Modafinil to patients with a history of psychosis, depression or mania given the possible emergence or exacerbation of psychiatric symptoms.

Further information on the safety concern

In clinical trials of Modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% ( 13 per 1,585 ) in paediatric patients ( age <17 years, these rashes included 1 case of possible Stevens-Johnson Syndrome and one case of apparent multi-organ hypersensitivity ), no serious skin rashes having been reported in adult clinical trials ( 0 per 4,264 ) of Modafinil.

Serious cases of rash, including Stevens-Johnson Syndrome ( SJS ), Toxic Epidermal Necrolysis ( TEN ) and Drug Rash with Eosinophilia and Systemic Symptoms ( DRESS ) have been reported in adults and children in worldwide post-marketing experience.

Provigil is not approved for use in children for any indication; Modafinil is indicated for the symptomatic relief of excessive sleepiness associated with narcolepsy, Obstructive Sleep Apnoea/Hypopnoea Syndrome ( OSAHS ) or moderate to severe chronic Shift Work Sleep Disorder ( SWSD ) in adult patients.

Source: Medicines and Healthcare product Regulatory Agency – MHRA, 2008

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