Copies of letters sent to healthcare professionals in September 2014, to inform of new safety information and advice.

Date sent


Safety information

1 Sept 2014

Avonex, Rebif, Plegridy (interferon beta 1a) Betaferon, Extavia (interferon beta-1b)PDF file (opens in new window) (253Kb)

There have been reports of thrombotic microangiopathy (including fatal cases) and nephrotic syndrome linked to interferon beta treatment. These conditions may develop several weeks to several years after starting treatment with interferon beta. Be vigilant for early signs or symptoms of these conditions and treat these conditions promptly if they occur, in line with the advice in the letter. See also Drug Safety Update article from December 2013.

8 Sept 2014

Simulect (basiliximab)PDF file (opens in new window)(275Kb)

This is a reminder that Simulect is indicated for preventing acute organ rejection only for allogeneic renal transplantation in patients receiving organ transplantation for the first time. Efficacy and safety have not been proven for the prevention of acute rejection in recipients of non-renal solid organ allografts. In several small clinical trials in heart transplant recipients, serious cardiac adverse events have been reported more frequently with Simulect than with other agents.

10 Sept 2014

OncoTICE (attenuated bacilli of Mycobacterium bovis, prepared from a culture of Bacillus Calmette-Guérin

[BCG])PDF file (opens in new window)(177Kb)

There is a supply shortage of OncoTICE in the UK. As an interim measure, a batch which was packaged for a different country has been made available to the UK. This batch does not contain a Patient Information Leaflet (PIL) in the pack. Copies of the PIL are being distributed along with the ordered batches. Please ensure that patients have access to these PILs.

12 Sept 2014

Intravenous nicardipinePDF file (opens in new window)(134Kb)

Nicardipine should be given by a specialist and in a well-controlled environment (eg, hospital or intensive care unit). In adults, start continuous infusion at a rate of 3‐5 mg/h. The rate can then be increased but should not exceed 15 mg/h. When the target blood pressure is reached, gradually reduce the dose. Monitor blood pressure continuously during infusion and for at least 12 hours after the end of the infusion.

18 Sept 2014

Motilium (domperidone) PDF file (opens in new window)(103Kb)

Domperidone is associated with a small increased risk of serious cardiac side effects. Its use is now restricted to the relief of symptoms of nausea and vomiting and the dosage and duration of use have been reduced. Domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors (see letter and Drug Safety Update article from May 2014) and should no longer be sold without a prescription.

18 Sept 2014

Sanomigran (pizotifen hydrogen malate)PDF file (opens in new window) (444Kb)

The Sanomigran product range (0.5 mg tablet, 1.5 mg tablet, and Elixir 0.25mg/5ml) is being discontinued due to the closure of the manufacturing sites where Sanomigran was produced for the UK.
Please stop prescribing Sanomigran products. Switch patients currently taking Sanomigran products to alternative treatments, based on the patient’s medical history. These could be generics of pizotifen hydrogen malate tablets or other medicines for the same indication. Withdrawal symptoms have been reported when pizotifen treatment is stopped suddenly. Therefore, gradual withdrawal is recommended.

29 Sept 2014

Tegretol Chewtabs (carbamazepine)PDF file (opens in new window)(143Kb)

Tegretol (carbamazepine) Chewtabs (100 mg and 200 mg) are being discontinued. Do not start new patients on Tegretol Chewtabs. Switch patients currently prescribed Tegretol Chewtabs to alternative treatments Abrupt withdrawal of Tegretol may precipitate seizures, therefore withdrawal should be gradual. If treatment with Tegretol Chewtabs has to be withdrawn abruptly in a patient with epilepsy, the changeover to another anti-epileptic drug should be performed under the cover of a suitable drug.

Sept 2014

Vfend (voriconazole)PDF file (opens in new window)(95Kb)

Voriconazole is associated with a risk of phototoxicity and skin squamous cell carcinoma (SCC). If phototoxic reactions occur, refer the patient to consult a dermatologist and consider stopping voriconazole treatment. If voriconazole treatment is continued despite a phototoxic reaction, the skin should be checked frequently and thoroughly to detect and manage precancerous lesions as early as possible. Stop voriconazole treatment if precancerous skin lesions or SSC are identified. Voriconazole is also associated with a risk of liver toxicity. The enclosed risk minimisation materials have been updated to align with recent changes to the voriconazole product information (see Drug Safety Update article from May 2014).


Posted on the UK MHRA website on 10 October 2014