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Dr. Bob is Robert Hsiung, MD,
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Posted by ed_uk2010 on July 26, 2010, at 16:53:41
From the EMEA website....
European Medicines Agency recommends restricting the use of modafinil (Provigil)
Doctors and patients advised to use modafinil for treatment of narcolepsy only; all other indications to be removed from product information
The European Medicines Agency has recommended restricting the use of modafinil-containing medicines. The medicine should only be used to treat sleepiness associated with narcolepsy. 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.
Modafinil is a wakefulness promoting agent, currently licensed in 21 countries in Europe. They are available under the following invented names: Modasomil, Modiodal, Provigil and Vigil, and as generic medicines.
The review by the Agencys Committee for Medicinal Products for Human Use (CHMP) 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.
On the basis of the available data the Committee concluded that the benefits of these medicines only outweighed their risks in the therapeutic indication narcolepsy, a chronic sleep disorder characterised by excessive daytime sleepiness. For all other indications the Committee found that the risk for development of skin or hypersensitivity reactions and neuropsychiatric disorders outweighed the evidence for clinically important efficacy. Therefore, the Committee concluded that all other indications should be withdrawn from the marketing authorisations of these medicines.
The risk of development of serious skin and hypersensitivity adverse reactions appears to be higher in children than in adults. The Committee concluded that the product information should carry a recommendation saying that modafinil should not be prescribed to 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.
There are some reports that modafinil is being used recreationally for performance enhancement. However, the data seen by the Committee did not allow it to make firm recommendations regarding this risk. The CHMP has requested that the marketing authorisation holders continue to provide further information to monitor the potential for abuse.
Posted by Justherself54 on July 26, 2010, at 19:44:10
In reply to New European restrictions on the use of Provigil, posted by ed_uk2010 on July 26, 2010, at 16:53:41
<<skin or hypersensitivity reactions and neuropsychiatric disorders
Hi Ed..thanks for the article. Do you know how these disorders present themselves? I take modafinil occasionally and don't notice any side effects at all.
Posted by Phillipa on July 27, 2010, at 0:20:37
In reply to Re: New European restrictions on the use of Provigil, posted by Justherself54 on July 26, 2010, at 19:44:10
Ed I think my nursing newsletter listed providgil and nuvidgil as risky meds also forget why. PJxxx
Posted by West on August 4, 2010, at 19:03:09
In reply to Re: New European restrictions on the use of Provigil, posted by Phillipa on July 27, 2010, at 0:20:37
Interesting that they mention psychiatric disorders. Anxiety or depression I suspect.
I eventually got depression from it.
Posted by Phillipa on August 4, 2010, at 21:22:16
In reply to Re: New European restrictions on the use of Provigil, posted by West on August 4, 2010, at 19:03:09
West really? Can you explain what you feel caused depression. I also feel anxiety. Phillipa
Posted by weatherfreak on August 9, 2010, at 20:48:51
In reply to Re: New European restrictions on the use of Provigil, posted by Phillipa on July 27, 2010, at 0:20:37
Modafinil was probably one of the best meds I have every taken for depression and it lasted the longest too. I got 18 months off modafinil and I suffer from bad anxiety. It didn't make me anxious at all, it just stopped working.
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