Pecfent in-use expiry extended to 60 days

22nd November 2012

The UK SPC for Pecfent (fentanyl citrate) nasal spray 100microgram/spray and 400microgram/spray has been updated. The in-use expiry of the product has been extended from 14 days to 60 days i.e. the SPC now reads:

“If the product has not been used for 5 days, re-prime by spraying once. Discard bottle 60 days after first opening.”

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Antidepressant drugs therapeutic review

15th November 2012

A therapeutic review on antidepressant drugs has been published in the Journal of Pain and Symptom Management (JPSM): 

Howard P. et al (2012) Therapeutic Reviews: Antidepressant drugs. Journal of Pain and Symptom Management. 44: 763-783. 

This is the 11th article in the series; previous ones include Octreotide (July 2010), Propofol (September 2010), Psychostimulants (November 2010), Thalidomide (January 2011), Ketamine (March 2011), Antipsychotics (May 2011), Loperamide (August 2011), Anti-epileptics (November 2011), Stimulant laxatives (February 2012) and Fentanyl; transmucosal (July 2012). All are based on monographs featured in the Palliative Care Formulary.

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Denosumab; fatal cases of severe symptomatic hypocalcaemia

15th November 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have highlighted cases of severe symptomatic hypocalcaemia that have occurred in patients receiving denosumab 120mg (Xgeva^®; authorized for use prevention of skeletal related events in adults with bone metastases from solid tumours) or 60mg (Prolia^®; authorized for use in osteoporosis).

Hypocalcaemia is a known risk with denosumab use, especially in patients with severe renal impairment (creatinine clearance <30 mL/min) or receiving dialysis. Severe symptomatic hypocalcaemia, including three fatal cases, has been reported in patients receiving denosumab 120mg. Although hypocalcaemia with denosumab most commonly occurs within the first 6 months of dosing, it can occur at any time during treatment.

Pre-existing hypocalcaemia must be corrected prior to initiating denosumab, and supplementation of calcium and vitamin D is required in all patients receiving the 120mg dose unless hypercalcaemia is present. Periodic monitoring of calcium levels (at the discretion of the prescriber) is recommended after use of denosumab in patients predisposed to hypocalcaemia, including those with severe renal impairment.

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Die September/Oktober Ausgabe des APM Newsletter ist fertig

13th November 2012

The September/October issue of APM Newsletter for German-speaking users of www.palliativedrugs.com is available.

Die September/Oktober Ausgabe des APM Newsletters ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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EMA review of cardiovascular safety of NSAIDs

13th November 2012

The European Medicines Agency (EMA) has finalised a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs). The review confirms the findings from previous reviews, conducted in 2005 and 2006, which concluded that the overall benefit-risk balance of NSAIDs remained positive, but that a small increased cardiovascular risk could not be excluded.

Most of the data related to diclofenac, ibuprofen and naproxen. The latest evidence appears to further highlight a consistent but small increase in the risk of cardiovascular undesirable effects for diclofenac compared with other non-selective NSAIDs, similar to the risks of COX-2 inhibitors. This information, particularly with long-term use of high doses and in patients who are already at high risk, is well recognised and warnings have been included in the SPC for some years. However, the EMA will now assess all available data on diclofenac (both published and unpublished) to consider the need for updated treatment advice. In relation to naproxen and ibuprofen, the current treatment advice adequately reflects the knowledge regarding the safety and efficacy of these medicines.

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MHRA Medicines Device Alert for Inadine dressings

12th November 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medicines Device Alert for Inadine^® PVP-I non adherent dressing (9.5cm x 9.5 cm) manufactured by Systagenix Wound Management (Product code: P0149; Lot numbers: 1227/1228/1229). There is a possible risk of infection due to compromised sterility, and the affected batches should not be used. For further information see the full alert below.

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Suboxone SL tablets replaced by SL film in US

8th November 2012

Sublingual (SL) combination tablets containing buprenorphine and naloxone (Suboxone; Reckitt Benckiser, Warren, NJ, USA), are being replaced by a sublingual film in the US. The tablet formulation, authorized for maintenance treatment in opioid dependence, is now off-patent and available as a generic product. The manufacturer states that the sublingual film has a faster dissolving rate, a more favourable taste and improved child-safety packaging.

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