Professional Documents
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NSAID controversy
Non-steroidal anti-
$30m Yasmin patent payout Etopophos shortages
The Therapeutic Goods
inflammatory drugs (NSAIDs) have Bayer will receive more than Without the protection of their Administration (TGA) has advised
been shown to be associated $30 million in damages and intellectual property, research- that supply shortages of Etopophos
with up to a 50% increased risk of interest after receiving a favourable driven pharmaceutical companies etoposide 1 g (as phosphate) and
an out-of-hospital cardiac arrest judgement in its long-running case cannot bring new medical Etopophos etoposide phosphate
(OHCA). with Generic Health over patent innovations to those patients who 113.6 mg (equivalent to 100 mg
The case-time-control study out infringement for its Yasmin and YAZ need them most, Ambrogio said. etoposide) powder for injection
of Copenhagen University Hospital, oral contraceptives. vials are expected to continue until
Denmark, investigated the records The Federal Court of Australia 01 Aug 2017.
of 28,947 people with OHCA, 3,376 ruling found Generic Health had Chemotherapy Previously, health professionals
of whom were treated with an infringed Bayers patent on the were advised that supply would
NSAID up to 30 days prior. products by manufacturing and
change deferred resume next month.
The Australian Self-Medication selling the oral contraceptive The Health Department has The TGA advises that the
Industry (ASMI) acknowledged known as Isabelle. advised of an extension for alternative product Etoposide 100
the study, with spokesman Steve The original judgement was the mandatory inclusion of the mg/5 mL is available.
Scarff saying, it is important to handed down in 2013 but was Compounder ID with eligible claims For more info contact the TGA on
note that the study was conducted stayed pending an appeal, which under the Efficient Funding for medicine.shortages@tga.gov.au.
in patients with an average age was later dismissed along with Chemotherapy (EFC) scheme.
of 70 years who were prescribed an application for special leave to Previously it was intended that
NSAIDs, usually at higher doses appeal to the High Court in 2014. the compounder ID would become Vit B protects against
and for longer duration than are Bayers claim for damages compulsory for claims lodged air pollution effects?
recommended and available for amounted to $25 million, based effective from 01 Apr 2017.
a SMALL scale human trial has
OTC use. on an assessment of its lost profits However according to an update
suggested that high doses of
These elderly patients had where each sale of Isabelle, and on Fri, a number of approved
vitamin B supplements (2.5mg of
pre-existing health conditions and of Petibelle, a generic version of suppliers have indicated that the
folic acid, 50mg of vitamin B6, and
were on other medications, some Yasmin introduced by Bayer, was necessary amendments to their
1mg of vitamin B12) may offset the
of which could have increased their taken to be a lost sale of Yasmin. dispensing software may not be
damage caused by fine particulate
risk factors, he said. Nelson Ambrogio, gm of Bayer ready in time to facilitate this.
matter as found in heavily polluted
Scarff said consumers should note Pharmaceuticals Australia/NZ, The department says it will now
places like Beijing or Mexico.
label warnings on NSAIDs and seek said the decision confirms the provide three months notice before
The most dangerous of these
the advice of their pharmacist or companys intellectual property the field becomes mandatory.
particles is referred to as PM2.5,
doctor if they have certain existing rights relating to Yasmin and YAZ. Until then claims submitted
with a diameter of less than 2.5
health problems, require longer We will always defend these without the compounder ID will
micrometres, coming from diesel
term treatment or if they are taking rights whenever this becomes continue to generate a warning but
cars and wood burning stoves.
other medicines. necessary and will continue to do so. will not be rejected.
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