Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Safety updates
MHRA warns against Beline herbal supplement
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning advising people not to take the illegal herbal supplement Beline capsules. Analysis of samples of Beline have revealed that the product, which claimed to be herbal, actually contained chlorphenamine, oxetacaine, piroxicam, and betamethasone. There have been several reports of adverse reactions to Beline. For more information click here.
MHRA communication on NSAIDs and risk of heart problems
The UK Medicines and Healthcare products Regulatory Agency (MHRA) have commented on the recent international review that reports that the use of NSAIDs can increase the risk of heart attack or stroke by one-third. MHRA state that the findings are not new; an increased risk of heart attack or stroke with some NSAIDs has been well recognised for some years, particularly with long-term use of high doses and in patients who are already at high risk. However, for most patients the risks of side effects are outweighed by the benefits of treatment. MHRA states that to minimise risk, its advice remains that all NSAIDs should be used for the shortest time and at the lowest dose necessary to control symptoms. For more information click here.
Drug updates
US FDA approve tapentadol extended-release
The US. Food and Drug Administration (FDA) has approved tapentadol extended-release formulation, (Nucynta ER, Janssen Pharmaceuticals). The drug is available in 50mg, 100mg, 150mg, 200mg, and 250mg tablet strengths and is designed to be taken twice daily for the management of moderate to severe chronic pain in adult patients who need continuous, around-the-clock pain relief for an extended period of time. Janssen’s immediate-release formulation of tapentadol was approved by the FDA in 2008. Tapentadol, a centrally-acting synthetic analgesic, is a Schedule II controlled drug. For complete administration and safety recommendations, see the Prescribing Information and the Nucynta ER Risk Evaluation Mitigation Strategy (REMS) documentation.
US FDA approve more REMS
The US Food and Drug Administration (FDA) has approved the Risk Evaluation Mitigation Strategy (REMS) for Actiq (oral transmucosal fentanyl citrate), Fentora (fentanyl buccal tablet) and Nucynta ER (tapentadol m/r tablets).
A full list of all approved REMS (which also includes other fentanyl, buprenorphine, hydromorphone, morphine, oxycodone and thalidomide preparations) is available from here.
Tramadol oral drops solution launched in UK
Tramadol oral drops 100mg/mL solution (Goldshield, 08700 703033) has been launched in the UK for the treatment of moderate to severe pain. The oral solution is not intended as a fast action relief for breakthrough pain, the SPC states, “If tramadol drops are used for acute pain, it should be stressed that its activity is somewhat delayed in comparison to that of other analgesics.” Also, it has not been licensed for children under 12 years. The dosage is expressed as drops (50mg = 20drops) and the 10mL bottle contains an integral dropper. The drops should be diluted with a glass of water before administration. The cost of a 10mL bottle (approx 20 doses of 50mg) = £3.50. Full details are in the SPC.
Midazolam oromucosal solution granted first paediatric European marketing authorisation
The European Commission has granted the first ever new Paediatric Use Marketing Authorisation (PUMA) for Buccolam (midazolam, oromucosal solution), for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years of age.
Buccolam is oral midazolam provided in an age-specific, ready to use, pre-filled syringe containing an individual dose for buccal delivery. It is expected that the product will be available in the UK from October 2011.
A PUMA is a new type of centralised marketing authorisation designed to encourage the development of older medicines, no longer covered by a patent, specifically for use in children. For more information click here.
AWMSG support the use of PecFent
The All Wales Medicines Strategy Group (AWMSG) has supported the use of fentanyl nasal spray (PecFent, Archimedes) within NHS Wales for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. It should be considered as an option when immediate release opioids (e.g. morphine, oxycodone) are inadequate or unsuitable. It should be initiated by, and remain under the supervision of, a specialist physician experienced in the management of opioid therapy in cancer patients and be prescribed by brand name to avoid automatic substitution. PecFent may be suitable for shared care within NHS Wales for the above indication.
PecFent was also accepted last year for use in NHS Scotland by the Scottish Medicines Consortium (SMC) but was not recommended by the North East Treatment Advisory group (NETAG). Currently NETAG does not recommend the novel fentanyl analgesics (Abstral, Effentora, Instanyl or PecFent) for breakthrough pain associated with cancer.
US FDA approve denosumab
The US Food and Drug Administration (FDA) has approved denosumab (Prolia, Amgen) for the following indications:
- to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
- to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.
Lorazepam injection – UK supply discussed
The British Medical Journal (BMJ) has printed a letter from Pfizer discussing the current lack of supply of lorazepam injection in the UK. Supply has been a problem since the middle of 2010 and was expected to resume to normal in late 2011. However, in June 2011 the sterile manufacturing activities of Recipharm, who was producing lorazepam for Pfizer, closed. Pfizer states that it is working to ensure the long term resupply of lorazepam injection to UK customers and stocks are expected in the second quarter of 2013. It is also exploring short term resupply alternatives, and will continue to update the UK regulatory authorities on progress. Lorazepam injection is available in the US, although it is not manufactured or supplied by Pfizer. It can be imported as an unlicensed medicine on a named patient basis.
Surveys
Assisted dying – should the law be changed?
Results from this www.palliativedrugs.com survey (May – August 2011) can be downloaded from here.
Prepared by Sarah Charlesworth and Andrew Wilcock