Monthly lists of letters for healthcare professionals on the safety of medicines

 

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

Date sent

Medicine

Safety information

4 June 2014

Triomel peripheralPDF file (opens in new window) (138Kb)

The maximum recommended infusion rate has been reduced for children aged 2 to 11 years. New guidelines recommend a maximum infusion rate of 0.13 g/kg/hour for lipids for children aged 2 to 11 years. As a result, the maximum infusion rates for fluids, amino acids, and glucose will also be updated.

11 June 2014

Ivabradine (procoralan)PDF file (opens in new window) (111Kb)

Carefully monitor patients taking ivabradine for bradycardia or its symptoms (eg dizziness, fatigue, hypotension). Discontinue ivabradine treatment if resting heart rate becomes too low or symptoms of bradycardia persist. Do not use ivabradine with heart rate-reducing calcium channel blockers such as verapamil or diltiazem. Review the treatment of patients currently using ivabradine as appropriate. The usual starting dose of ivabradine is 5mg twice daily. The maintenance dose is 7.5mg twice daily. See the Drug Safety Update article published in June.

16 June 2014

Vibativ (telavancin)PDF file (opens in new window)(1447Kb)

Telavancin is contraindicated in people with severe renal impairment (creatinine clearance <30ml/min, including people undergoing haemodialysis). Monitor renal function daily for at least the first 3 to 5 days of treatment and every 48 to 72 hours thereafter in anyone receiving telavancin.
QTc prolongation was observed in clinical trials. Use caution when administering telavancin with other QTc-prolonging medicines and in people who are at high risk of QTc prolongation.
Telavancin is contraindicated during pregnancy.

18 June 2014

Dantrium Intravenous (dantrolene sodium)PDF file (opens in new window)(265Kb)

Some vials of dantrolene sodium for intravenous use may contain visible particles after reconstitution. These particles are crystals of dantrolene sodium. All newly issued packs of intravenous dantrolene are being supplied with one filter needle per vial of dantrolene. Draw up reconstituted dantrolene sodium with this needle to reduce the risk of administering undissolved crystals to patients. Existing stock is not affected and does not require filtering.

18 June 2014

Transdermal fentanyl (‘patches’)PDF file (opens in new window) (220Kb)

Accidental exposure to transdermal fentanyl can cause life-threatening harm. It can occur if a patch is swallowed or transferred to another individual. To reduce this risk, advise patients and caregivers to use and dispose of patches safely (see letter for details).

June 2014

Tepadina injection (thiotepa)PDF file (opens in new window) (355Kb)

Tepadina Injection in UK livery is currently out of stock and is expected to remain out of stock until July 2014. However, it is available in Spanish livery. During the period over which Tepadina Injection in UK livery is out of stock, customers placing orders for Tepadina Injection will receive the product in Spanish livery.

 

Posted on the UK MHRA website on 27 June 2014