Medicines related to valproate: risk of abnormal pregnancy outcomes

Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).


Ustekinumab (Stelara): risk of exfoliative dermatitis

If you suspect exfoliative dermatitis caused by an adverse drug reaction to ustekinumab, stop treatment.


Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasis

Measure serum immunoglobulin levels if recurrent infections develop.


Oral diclofenac no longer available without prescription

Oral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.


Aceclofenac (Preservex): updated cardiovascular advice in line with diclofenac and COX-2 inhibitors

Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.


Yellow Card extended to include devices, counterfeits and defective medicines

We have simplified our medicine and device incident report systems by bringing them all under the Yellow Card Scheme.



Posted on the UK MHRA website on 26 January 2015