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US FDA approve tapentadol extended-release

30th September 2011

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 Medication Guide and the Nucynta ER REMS Program documentation.

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MHRA communication on NSAIDs and risk of heart problems

29th September 2011

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 increase 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 state 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.

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End of Life Care strategy annual report

29th September 2011

The UK Department of Health (DH) has published the third annual report of the End of Life Care strategy.

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Consultations on independent prescribing for physiotherapists and podiatrists

22nd September 2011

The UK Department of Health and Medicines and Healthcare products Regulatory Agency (MHRA) have jointly launched two public consultations concerning proposals for independent prescribing for physiotherapists and podiatrists. Both consultations close 8 December 2011.

Consultation for physiotherapists
Consultation for podiatrists

Lorazepam injection - UK supply discussed

22nd September 2011

The British Medical Journal (BMJ) has printed a letter and a reply 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 for customers and patients, 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.

BMJ Pfizer reply (subscription required)

US FDA approve denosumab

20th September 2011

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.

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NICE consults on changes to recommendations for neuropathic pain

15th September 2011

The UK National Institute for health and Clinical Excellence (NICE) is consulting on proposed changes to some of the recommendations made in its clinical guideline on the pharmacological management of neuropathic pain in adults in non-specialist settings (CG 96; March 2010). This action follows concerns about the associated costs that pregabalin may bring to the NHS as one of the first line treatment options for adults with neuropathic pain, and considers new evidence regarding the first-line treatment options. 

The main recommendations regarding first-line drug therapy are:

• Oral amitriptyline or gabapentin should be offered as first-line treatment, except for those with painful diabetic neuropathy, who should be offered duloxetine (amitriptyline if this is contra-indicated)

• Consider imipramine or nortriptyline as alternatives if amitriptyline is effective but not tolerated

• Consider pregabalin if gabapentin is effective but the patient has difficulty adhering to the dosage schedule or cannot tolerate the adverse effects. 

Comments on the draft amended guideline must be via registered stakeholders. The consultation closes at 9am on 10th October 2011. The current clinical guideline should be used until any further announcement is made. Further details including the list of stakeholders can be found on the website link below.

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FDA approve more REMS

14th September 2011

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 downloadable list of all approved REMS (which also includes other fentanyl, buprenorphine, hydromorphone morphine, oxycodone and thalidomide preparations) is available.

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Tramadol oral drops solution launched in UK

14th September 2011


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, "In case tramadol drops is 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.

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Midazolam oromucosal solution granted first paediatric European marketing authorisation

14th September 2011

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.

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AWMSG support the use of PecFent

14th September 2011

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 has also been accepted for use in NHS Scotland by the Scottish Medicines Consortium (SMC) last year, 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.

AWMSG report
SMC report
NETAG report

MHRA warns against Beline herbal supplement

14th September 2011

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.

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FDA approves fentanyl nasal spray

8th September 2011

The US Food and Drug Administration (FDA) has approved the first fentanyl nasal spray (Lazanda, Archimedes) for breakthrough pain in adults patients with cancer. It is due to be available late 2011. The product is already available in five European Countries,including the UK, (known as PecFent). Prescribing information and REMS documentation are available.

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NPC guide to prescribing specials

1st September 2011

The UK National Prescribing Centre (NPC) has produced a good practice guide to prescribing specials which includes a quick practical checklist for prescribers (appendix 2).

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