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Safety updates

Gabapentin: risk of severe respiratory depression
The MHRA has highlighted a rare risk of severe respiratory depression in patients taking
gabapentin even without concomitant opioids. Dose adjustments may be necessary in patients at
higher risk of respiratory depression, including the elderly, those with compromised respiratory
function, respiratory or neurological disease, renal impairment, or taking other CNS depressants.
This advice follows a European review and the SPC for gabapentin is being updated. For more
information, click here.

Recombinant human erythropoietins: risk of severe cutaneous adverse reactions
MHRA has highlighted a very rare risk of severe cutaneous reactions in patients treated with any
recombinant human erythropoietin (r-HuEPO). The product information is being updated. For more
information, click here.

Solu-medrone 40mg: do not use in cows’ milk allergy
Solu-Medrone 40mg (methylprednisolone injection) uses lactose produced from cows’ milk as an
excipient and may contain trace amounts of milk proteins. It should not be used in patients with a
known or suspected allergy to cows’ milk, as serious allergic reactions have been reported.
Other strengths of Solu-Medrone do not contain lactose. Lactose-containing methylprednisolone
medicines will be reformulated to remove any trace of milk proteins. Companies have been asked
to take steps towards lactose-free formulations by 2019. For more information, click here.

Clozapine: potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic
MHRA has reminded health professionals that clozapine has been associated with varying
degrees of impairment of intestinal peristalsis ranging from constipation (very common), to
intestinal obstruction, faecal impaction, and paralytic ileus (very rare). Patients should be advised
to report constipation immediately and it should be actively treated. Care should be taken in
patients receiving other drugs known to cause constipation (especially those with antimuscarinic
properties), patients with a history of colonic disease or lower abdominal surgery, and in patients
≥60 years. Clozapine is contra-indicated in patients with paralytic ileus. For more information, click

Hot topics

Gabapentin and pregabalin consultation on proposals to schedule under Misuse of Drugs
The government has opened a consultation on proposals to schedule gabapentin and pregabalin
under the Misuse of Drugs Regulations 2001. The preferred option, as recommended by the
Advisory Council on the Misuse of Drugs (ACMD) is that these drugs should be controlled as
Class C drugs (under the Misuse of drugs Act 1971) and placed in Schedule 3 (to the Misuse of
Drugs Regulations 2001). Comments are welcome from all interested parties by 22 January 2018.
For more information, click here.

Assessing fitness to drive: a guide for medical professionals
This government document, published in 2016, has recently been updated in the section entitled ‘Excessive sleepiness including obstructive sleep apnoea syndrome’. For more information, click

Drug updates

Authorized quetiapine oral suspension now available
Quetiapine oral suspension 100mg/5mL (Rosemont Pharmaceuticals) is now available as an
authorized product.
Quetiapine (generic)
Tablets 25mg, 100mg, 150mg, 200mg, 300mg, 28 days @ 100mg b.d.= £1.50.
Oral suspension 12.5mg/5mL, 25mg/5mL, 50mg/5mL, 28 days @ 100mg b.d.= £204
(unauthorized, available as a special order); price based on community specials tariff.
Oral suspension 100mg/5mL, 28 days @ 100mg b.d.= £177.
For the SPC, click here.

US approves pregabalin modified-release tablets
Pregabalin modified-release tablets (Lyrica CR; Pfizer) have been approved in the US. They are
authorized for once daily management of neuropathic pain associated with diabetic peripheral
neuropathy or postherpetic neuralgia. The modified-release tablets are available as 82.5mg,
165mg and 330mg and should be given once daily after the evening meal. For the US prescribing
information, click here.

AWMSG: Noqdirna accepted for use
The All Wales medicines Strategy Group (AWMSG) has accepted Noqdirna (desmopressin oral
lyophilisate), for restricted use in patients ≥65y only, for the symptomatic treatment of nocturia due
to idiopathic nocturnal polyuria in adults .For more information, click here.

Paracetamol infusion risk management
Risk management material for paracetamol 10mg/mL infusion has been produced by Actavis,
highlighting the risks of dosing error and providing guidelines for correct administration. For more
information, click here.

Latest additions

PCF6 now available!
We are delighted to announce the publication of the 6th edition of the Palliative Care Formulary
(PCF6) book. PCF6 print edition is available to purchase via our website store at a cost of £55
(including P+P in the UK). As well as being extensively updated, PCF6 has been re-organised into
a more user-friendly format and contains new monographs. Please note if you require bulk
purchases please contact to discuss your requirements. The on-line
version of the Palliative Care formulary is always the most up to date version and is regularly
updated. PCF6 print version reflects the content of the on-line version as of the end of September
2017. Individual annual access to this continually updated resource remains at £50. For more
information and details of combination packages, see our website store.

Hyoscine butylbromide injection in palliative care – What is your experience?
Results from our survey (May-August 2017), click here.

Prepared by Sarah Charlesworth and Andrew Wilcock

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