Safety Alerts & Recalls

What does this mean?

For the majority of patients taking modafinil (also known by the brand name Provigil), modafinil's benefits will continue to outweigh its risks. However, certain patients may need their treatment reviewed or more closely monitored, especially patients using modafinil for shift-worker sleep disorder or obstructive sleep apnoea, or patients with high blood pressure, irregular heart beats, or mood and behaviour disorders. If you are taking modafinil and are experiencing side effects, or have other concerns regarding this alert, then please speak with your doctor or other healthcare professional.

Further Restrictions and Cautions Announced For Modafinil (Provigil)

The Medicines and Healthcare Products Regulatory Agency (MHRA) and the manufacturers of modafinil (Provigil) have advised healthcare professionals about further restrictions and cautions for the use of this drug. This follows a Europe-wide restriction on the use of modafinil to the narcolepsy indication, which was covered in a MediGuard alert issued in August 2010.

Updated product information advises against the use of modafinil in people with uncontrolled raised blood pressure or an irregular heartbeat, in children up to 18 years old, and in women who are pregnant or breastfeeding. Treatment should be discontinued and not restarted in patients with serious skin or hypersensitivity reactions, or those with psychiatric disorders such as suicidal thinking. Modafinil should be used with caution in patients with a history of psychosis, depression, mania, or patients abusing alcohol, drugs or illicit substances. An electrocardiogram (ECG) test to measure heartbeat rhythm should be conducted before treatment with modafinil is started, and heart function (particularly blood pressure and heart rate) should be monitored regularly. Modafinil is also no longer indicated for shift-worker sleep disorder and obstructive sleep apnoea.

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Source: MHRA
Publication Date: 2011-03-11
Last Updated: 2011-03-11

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