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

Date sent

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Medicine

Safety information

October 2013

Short-acting beta agonists (terbutaline, salbutamol, hexoprenaline, ritrodine, fenoterol, isoxsuprine)

Letter 1PDF file (opens in new window) (121Kb)

Letter 2PDF file (opens in new window) (156Kb)

Letter 3PDF file (opens in new window) (229Kb)

Oral and suppository SABAs should not be used in obstetric indications. Parenteral SABA treatment duration should be limited to 48 hours maximum in the inhibition of premature labour.

7 October 2013

Numeta G16%EPDF file (opens in new window) (113Kb)

Risk for hypermagnesaemia when administered to term newborn infants and children up to 2 years. HCPs should:

  • monitor serum magnesium and other electrolyte levels
  • be vigilant for signs of hypermagnesaemia
  • stop/reduce Numeta G16%E infusion if serum magnesium levels are elevated or signs of hypermagnesaemia are identified

14 October 2013

Valdoxan/Thymanax (Agomelatine)PDF file (opens in new window) (153Kb)

Monitor liver function and do not use in people with high transaminase levels (>3 x ULN) or ≥75years.

17 October 2013

Risperdal, Risperdal consta (risperidone), Invega (paliperidone), Xeplion (paliperidone palmitate)PDF file (opens in new window) (285Kb)

Risk of intraoperative floppy iris syndrome in people undergoing cataract surgery while taking α1a-adrenergic antagonists.

23 October 2013

Jevtana ▼ (cabazitaxel)PDF file (opens in new window) (140Kb)

Reminder of reconstitution instructions to avoid overdose: pharmacies should review worksheets they use in the preparation of cabazitaxel. This is to ensure that they inform pharmacy staff to add the entire content of the solvent vial to the concentrate vial.

28 October 2013

NovoMix30 Penfill and FlexPen (biphasic insulin aspart 30)PDF file (opens in new window) (160Kb)

Certain batches are being recalled due to incorrect insulin concentration. 

29 October 2013

IV iron preparations (Ferinject, Venofer, Ferrologic, Cosmofer, Monofer, Diafer)PDF file (opens in new window) (55Kb)

All IV iron preparations can cause serious hypersensitivity reactions. These may occur even when a previous administration has been tolerated. See http://tiny.cc/alvr5w for the Drug Safety Update article.

31 October 2013

Lariam (mefloquine hydrochloride)PDF file (opens in new window) (69Kb)

Mefloquine may induce serious neuropsychiatric disorders. Do not prescribe mefloquine for malaria chemoprophylaxis in people with past or present psychiatric disturbances.

 

Posted on the UK MHRA website on 5 November 2013