Provigil Restricted in Europe

Late last year, the European Medicines Agency (EMEA) recommended that use of <"">Provigil (modafinil) be restricted to the treatment of narcolepsy because of its association with a number of side effects, including serious skin reactions. The EMEA required that all other indications be removed from product information for Provigil and other modafinil-containing medicines.

Provigil and modafinil-containing medicines are used in patients who suffer from excessive sleepiness. Excessive sleepiness can be caused by narcolepsy, a disease that causes the person to fall asleep during the day, or it can be due to disturbed night-time sleeping patterns leading to daytime sleepiness. This can be seen in people who work a shift-pattern or in those who suffer from obstructive sleep apnoea (a condition in which pauses in breathing occur repeatedly during the night, disturbing sleep). Excessive sleepiness can also happen with no known causes (idiopathic hypersomnia).

In many cases, Provigil is used in the treatment of Attention Deficit Hyperactivity Disorder, Multiple Sclerosis and depression. It is estimated that as much as 90 percent of all Provigil prescriptions are written for off-label use.

In October 2007, the U.S. Food & Drug Administration updated the Provigil label to warn of several dangerous side-effects associated with its use, including <"">Stevens Johnson Syndrome, a sometimes life-threatening hypersensitivity complex affecting the skin and the mucous membrane, as well as <"">Toxic Epidermal Necrolysis, another life-threatening, and usually drug-induced, dermatological condition that is characterized by the detachment of the top layer of skin from the lower layers of the skin all over the body. In addition to the skin disorders, the FDA has warned that Provigil use has been connected to severe psychiatric symptoms, including anxiety, mania, hallucinations, and suicidal thoughts.

Last November, following a review by the agency’s Committee for Medicinal Products for Human Use (CHMP), the EMEA said doctors and patients should no longer use the medicine for the treatment of idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnoea and chronic shift work sleep disorder. The CHMP review was initiated because of a number of safety concerns, relating to psychiatric disorders, skin and subcutaneous tissue reactions as well as significant off-label use and potential for abuse. The Committee concluded that the benefits of these medicines only outweighed their risks in the therapeutic indication narcolepsy, a chronic sleep disorder characterized by excessive daytime sleepiness. Therefore, the Committee concluded that all other indications should be withdrawn from the marketing authorizations of these medicines.

The Committee concluded that the product information should carry a recommendation saying that modafinil should not be prescribed to children, as the risk of hypersensitivity reactions appears to be higher in children.

The CHMP also identified particular cardiovascular risks with modafinil and recommended that the use of the medicine be contraindicated in patients with uncontrolled moderate to severe hypertension and in patients with cardiac arrhythmias.

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