Australian Doctor Australian Doctor 15th September 2017 | Page 8

News
Watchdog to review Panadol Osteo
The sustained released drug
causes overdose issues.
MICHAEL WOODHEAD
THE TGA is reviewing the
availability of sustained-
release paracetamol prod-
ucts such as Panadol Osteo.
The move follows an EU
ban on the products because
of overdose management
problems.
An European Medicines
Agency (EMA) commit-
tee has recommended that
665mg
sustained-release
paracetamol be withdrawn
from sale after clinicians
raised concerns about dif-
ficulties in treating patients
who had taken overdoses of
the long-acting analgesics.
“Experience has shown
that in overdose (particu-
larly at high doses), because
of the way the paracetamol
in modified-release products
is released in the body, the
usual treatment procedures
developed for immediate-
release products are not
appropriate,” the EMA’s
pharmacovigilance
risk
assessment committee said.
“If doctors are not aware
modified-release paraceta-
mol has been taken, which
affects decisions such as
when and for how long to
give an antidote, overdose
might result in severe liver
damage or death,” the EMA
review stated.
The TGA said it aware
of the EMA recommenda-
tions on paracetamol and
was “reviewing information
to determine what, if any,
action is required”.
A spokeswoman told
Australian Doctor that
the TGA had received 43
reports of overdoses with
modified-release paraceta-
mol products between 2005
and 2017, but none had a
fatal outcome.
According to paraceta-
mol overdose management
guidelines, absorption from
sustained release formulai-
tons may continue for up to
24 hours.
A spokesperson for GSK,
said Panadol Osteo had a
long history of safe use in
Australia and there were
clear protocols on how to
manage overdoses.
“We firmly believe in the
positive risk/benefit profile
of modified-release paracet-
amol,” she said.
In Brief
BELSOMRA (suvorexant)
®
Staff writers
A different approach to
the treatment of insomnia.
*
1–3 †
*BELSOMRA is the only orexin receptor antagonist for the treatment of insomnia. 1,2
†
BELSOMRA works differently to other sleep medications by inhibiting wake signalling. 1,3
Don’t mix hep B vax
No apparent evidence of:
WITH hepatitis B vaccine
shortages expected to
continue until 2018, the
Australian Technical
Advisory Group on
Immunisation (ATAGI) now
recommends two doses of
paediatric vaccine (0.5mL
per dose), administered
concurrently for an adult
if no adult vaccine is
available. However, ATAGI
warns not to mix different
brands of paediatric
hepatitis B vaccine to make
up one adult dose.
Physical dependence
1‡
Clinically-meaningful
rebound insomnia
1‡
In studies comparing BELSOMRA with placebo
‡
BELSOMRA is indicated for the treatment of insomnia characterised by difficulties with
sleep onset and/or sleep maintenance. 1
Following initiation of treatment, continuation should be re-evaluated after 3 months. 1
>5 million prescriptions written worldwide
Breastfeeding prevents
endometriosis: study
4
PBS Information: This product is not listed on the PBS.
BEFORE PRESCRIBING, PLEASE REVIEW THE APPROVED PRODUCT INFORMATION.
PRODUCT INFORMATION IS AVAILABLE AT WWW.MSDINFO.COM.AU/BELSOMRAPI
BELSOMRA ® (suvorexant 15mg and 20mg). Indications: Treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. Continuation should
be re-evaluated after 3 months. Contraindications: Narcolepsy; hypersensitivity to any ingredient. Precautions: Somnolence and CNS depressant effects, impairment of driving
skills and other activities that require mental alertness, rule out underlying psychiatric or physical disorders causing worsening of insomnia, complex behaviours associated with use
of hypnotics such as sleep driving, worsening depression or suicidal ideation, presence of severe COPD or severe OSA, sleep paralysis, hypnagogic/hypnopompic hallucinations,
cataplexy-like symptoms, abuse, severe hepatic impairment. Interactions: Co-administration with other CNS depressants or alcohol; strong or moderate CYP3A inhibitors, CYP3A
inducers, midazolam, digoxin. Adverse effects: fatigue, upper respiratory tract infection, diarrhoea, dry mouth, nausea, dizziness, somnolence, headache, abnormal dreams,
medication administration error, others: see full PI. Post-marketing experience: nightmare. Dosage: Take no more than once per night and within 30 minutes of going to bed,
with at least 7 hours remaining before the planned time of awakening. Based on PI approved 23 December 2016.
References: 1. BELSOMRA Product Information. 2. Herring WJ et al. J Clin Sleep Med 2016;12(9):1215–25 & Supplementary Tables. 3. Bennett T et
al. Pharm Ther 2014; 39(4): 264-6. 4. IMS Health, National Prescription Audit (US and Japan), November 2014–January 2017.
Copyright © 2017 Merck Sharp & Dohme Corp a subsidiary of Merck & Co. Inc., Kenilworth, New Jersey, USA.
All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited, Level 1, Building A, 26 Talavera Rd, Macquarie
Park, NSW 2113 Australia. NEUR-1207010-0036. First issued August 2017. BEL0011/AD_FPC_B.
8
BEL0011_B_FPC_Ad_AD_273hx210w_PR.pdf
| Australian Doctor | 15 September 2017
www.australiandoctor.com.au
10/08/2017 4:10 PM
BREASTFEEDING protects
against endometriosis
through its effect on
postpartum amenorrhoea,
US research suggests.
A retrospective review of
more than 72,000 women
found that their duration of
breastfeeding was inversely
associated with risk of the
debilitating condition.
BMJ 2017; online.
Push for GP staff to
act fast on stroke
GP reception staff should
be trained to recognise
and act quickly on the
symptoms of stroke,
according to new national
guidelines from the Stroke
Foundation. Staff should
also know to divert patients
who phone with stroke
symptoms to call triple 000.