European Medicines Agency to Review RoAccutane Safety

European Medicines Agency to Review RoAccutane Safety

Members of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) are to meet early June 2017 to Review RoAccutane.

This comes after a letter of evidence by Mr. David Roberts, the father of a UK suicide victim, was sent to Parliament encouraging action to be taken on behalf of a group of concerned parents. Parents whose children committed suicide after claiming Roaccutane left them with horrific side effects. In his letter Mr. Roberts highlighted several problems with RoAccutane the MHRA has refused to properly address:

  • Patients taking the drug without reading warnings in the patient information leaflet (P.I.L.),
  • Patients not wanting to quit the drug after side effects develop due to eagerness to rid themselves of acne
  • General under-reporting of adverse reactions
  • Suicides being under-reported and overlooked because of the stigma associated with it
  • An unclear relationship between RoAccutane’s (unknown) mechanism of action and effects on mental health
  • Lack of warnings of risk of sexual dysfunction in the patient information leaflet

 

20 suicides linked to RoAccutne were reported in Britain alone from 2012 to 2014 and the matter was discussed in British Parliament in late 2013. Even so, the MHRA has not increased warnings or restrictions on the drug.

The European Medicines Agency’s mission is protecting public health in 28 EU states in regards to pharmaceutical products and their PRAC committee is devoted to detecting, assessing, and communicating risk of adverse reactions. If you have suffered life-altering complications from RoAccutane, or other Isotretinoin product, please contact the PRAC committee member representing your nation to inform them of your experience with the drug.

 

Include the following in your email, if applicable:

  • Name (data protection will guarantee confidentiality) age, dosage, duration
  • Complete and thorough list of your side effects.
  • How and when your side-effects evolved.
  • Description of any depressive symptoms, including suicidal ideation or suicide attempt
  • Explanation of how/if these depressive symptoms differ from any experienced due to acne.
  • Description of sexual side-effects, or any other side-effect not listed in the patient information leaflet
  • How RoAccutane/Isotretinoin has affected and/or interrupted your study/work
  • How you feel about RoAccutane/Isotretinoin and any regrets you might have about taking it
  • Whether your side effects have been reported through a doctor, or other means, or if they have been reported
  • An account of your interactions with doctors when discussing side-effects

 

It is difficult for any researcher to investigate side-effects from RoAccutane when they are not officially recognized as being a potential risk of the drug. And others are less likely to seek alternative treatments for acne when the dangers of RoAcctuane can be so easily de-emphasized as myths. This is a chance to have your voices heard.

A list of PRAC representatives is available here

The meeting is scheduled to occur from June 6th-9th 2017

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