Copies of letters sent to healthcare professionals in June 2013, to inform of new safety information and advice.


Date sent


Safety information

13 June 2013

Dianette and all cyproterone acetate 2mg/ethinylestradiol 35 mcg productsPDF file (opens in new window) (343Kb)

Strengthening of warnings, new contraindications, and updated indication

19 June 2013

Revlimid (lenalidomide)PDF file (opens in new window) (433Kb)

Information to support safe use, including pregnancy-prevention measures

20 June 2013

Sublimaze (fentanyl)PDF file (opens in new window) (327Kb)

Risk of serotonin syndrome with coadministration of serotonergic drugs

24 June 2013

Retigabine (Trobalt)PDF file (opens in new window) (85Kb)

Treatment may lead to pigment changes of ocular tissues, including retina, and skin, lips, or nails. Restricted use to adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated

See also MHRA letter for healthcare professionals sent (external link) on June 27, 2013, regarding the suspension of licences for hydroxyethyl starch products.


Posted on the UK MHRA website on 1 July 2013