by Kazeem Olalekan MRPharmS

In August a number of communications on medicines safety were sent out to healthcare professionals via the MHRA. If you missed any of it then here are the summary. Full details are available on the MHRA website.

Number 1:

ONDANSETRONE – QTC prolongation – new dose restriction for intravenous ondansetron given for chemotherapy-induced nausea and vomiting in adults.

In summary, a single dose of intravenous ondansetron given for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults, must not exceed 16 mg (infused over at least 15 minutes).


Ondansetron causes a dose-dependent prolongation of the electrocardiographic-corrected QT interval (QTc), which can lead to Torsade de Pointes, a potentially life-threatening heart arrhythmia. Because of this potential safety risk, there are new dose restrictions in place for use of IV ondansetron.

Information provided by  GSK (GlaxoSmithKline)

Number 2:

TAMIFLU – Concentration of oral suspension to be changed from 12 mg/mL to 6 mg/mL

In summary,

  • Concentration of TAMIFLU® for Oral Suspension will be changed from 12 mg/ml to 6 mg/ml
  •  The dispenser will be changed from milligrams (mgs) to millilitres (mLs)
  •  The EU SPCs will be changed to include amended dosing tables to include a column for the volume in millilitres based on the new 6mg/ml formulation.

Prescriptions for Tamiflu® oral suspension should state the dose in millilitres and the new 6 mg/ml concentration should be used when available

This is very important to Pharmacists looking after children who might need this medication. My first thought is: Do we have protocols within my NHS Trust that has the old doses? (Next Step).

Information provided by  Roche

Number 3:

DEPOCYTE – Possible risk of sterility failure at manufacturing site – product recall in Europe

In summary,

DepoCyte (cytarabine liposome injection) authorised for the treatment for lymphomatous meningitis is the sole intrathecal liposomal cytarabine product licensed in Europe. A recent inspection by a Regulatory Authority identified critical deficiencies at the finished product manufacturing site, in particular, reduced sterility assurance in the manufacturing process, which gives rise to a possible risk
of sterility failure. At present, there is no evidence of any microbial contamination of product on the market or risk to patients.

In view of risk-benefit, the product is being recalled.

  • Patients currently receiving treatment with DepoCyte should be transferred to alternative therapy
  • No new patients should be initiated on DepoCyte treatment until further notice
  • In exceptional circumstances, in patients currently receiving treatment and for whom alternative treatments are not appropriate (e.g. for those patients who cannot tolerate more frequent injections), physicians may request a supply of DepoCyte for a specific patient in order to continue the treatment. Healthcare professionals should monitor patients closely for signs and symptoms of infection, including central nervous system infections, which could be linked to microbial contamination of DepoCyte

Read the document for treatment alternatives

Information provided by  Pacira Limited

Number 4:

CALCITONIN – Increased risk of malignancies with the long-term use of calcitonin. Calcitonin should no longer be used in the treatment of osteoporosis.

In summary,

Due to the higher incidence of malignancies, the following is concluded:

  • Calcitonin should no longer be used in the treatment of established post-menopausal osteoporosis, since the risks associated with calcitonin outweigh the benefits in this indication.
  • Patients being treated for osteoporosis with calcitonin should be switched to alternative treatment during the next scheduled (or routine) appointment.

The benefits of calcitonin continue to outweigh the risks in the short term treatment of:

  • Paget’s disease only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, e.g. in patients with severe renal impairment. Treatment in this indication should be limited in most cases to 3 months (Please see below, further information on recommendations to healthcare professionals).
  • Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures, with treatment limited to two to four weeks.
  • Hypercalcaemia of malignancy.

Remember to use the Yellow Card Scheme to report suspected adverse effects.

Information provided by  Novartis


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