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FDA Approves Risk Education and Awareness For Drugs Used to Promote “Awakeness”–Sleep Apnea & Work Shift Disor

Posted Oct 22 2010 7:33pm

Ok the title may have caught your attention as it certainly caught mine as I did not image know there were drugs to help those who do not get enough sleep due to sleep apnea or shift work disorder.  In short these are medications to keep one more alert if they have one those conditions and a couple others. 

The official name here is the Risk Evaluation and Mitigation Strategies, aka as REMS to ensure patient, doctor education and safety with ensuring that all side effects are known and understood.  From the websites below:

What is NUVIGIL?

NUVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder, or narcolepsy. image

In patients with OSA, NUVIGIL is used along with other medical treatments for this sleep disorder. NUVIGIL is not a replacement for your current treatment. Consult your doctor about the importance of continuing your current OSA treatment while taking NUVIGIL.

NUVIGIL is a federally controlled substance (C-IV) because it has the potential to be abused or lead to dependence. Please use NUVIGIL only as directed and keep in a safe place to prevent misuse and abuse.

What is PROVIGIL (modafinil), and what does it do?

PROVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder, or narcolepsy. image

In patients with OSA, PROVIGIL is used along with other medical treatments for this sleep disorder. PROVIGIL is not a replacement for your current treatment. Consult your doctor about the importance of continuing your current OSA treatment while taking PROVIGIL.

These are Schedule IV drugs so I can see why they want to ensure they are used properly and everyone knows the potential side effects.  I found this a bit odd as both websites state they are controlled substances and both could be addictive and yet we have a coupon here for a 7 day starter voucher?  This just struck me as being very odd for a drug that is a Class IV and is federally controlled.  Here we go again with marketing……BD

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FRAZER, Pa., Oct. 22 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH ) today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL® (armodafinil) Tablets [C-IV] and PROVIGIL® (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA).  Both the NUVIGIL and PROVIGIL REMS consist of a Medication Guide to inform patients about the potential risks associated with the use of these medications, a communication plan and a timetable for submission of assessments of the REMS.  The communication plan includes a Dear Healthcare Professional Letter, a Prescriber Brochure, a Pharmacist Action Letter and a dedicated REMS Internet Site. The introduction of the NUVIGIL and PROVIGIL REMS programs is consistent with the company's commitment to safe and appropriate use of its medications.

The goal of each REMS is to inform healthcare providers, patients and caregivers about the risks associated with these medications, including serious skin rash and hypersensitivity reactions.  The current product labeling for both medications contains a bolded warning that includes these risks. Neither medication is approved for use in the pediatric population for any indication.  In accordance with the approved REMS, the company is currently updating NUVIGIL and PROVIGIL labeling to include the Medication Guide.

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