Cephalon changes product info after Australia takes closer look at modafinil

(Oct. 7, 2011) Pharmaceutical maker Cephalon recently updated the safety literature it packages with modafinil following a risk-benefit review of the drug by Australia’s Therapeutic Goods Administration (a counterpart to the U.S. Food and Drug Administration).

Australia conducted the review in the wake of reports that some modafinil users suffered cardiovascular, nervous system and psychologic problems. The analeptic drug is commonly prescribed to keep awake patients who suffer from narcolepsy or from obstructive sleep apnea-induced excessive daytime sleepiness.

Cephalon – the target of a 2002 FDA misleading-marketing probe that resulted in the company agreeing to pay penalties totaling $425 million – sells modafinil in Australia under the brand name Modavigil. In the U.S., the drug’s name is Provigil, and has been available here since 1998.

Because no one is sure exactly how modafinil works, there exists the possibility that more problems with it will surface in the years ahead.

For example, Cephalon’s current Provigil information recommends against prescribing it to children – this, after the FDA in 2006 held that modafinil was unsuitable for treatment of attention deficit hyperactivity disorder (ADHD) in youngsters (prior to that, the drug had shown promise as an ADHD therapy).

Cephalon, headquartered in West Chester, Pa., leases the rights to make and distribute modafinil from French pharmaceutical firm Lafon.

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