[AF] Australia suspende el lumiracoxib

[Martín Cañás]

estimadas y estimados
la agencia reguladora australiana Therapeutic Goods Administration
suspende el lumiracoxib  despues de 8 RAMs graves incluyendo 2 muertes y 2
casos  que necesitaron de transplante hepatico
http://www.tga.gov.au/media/2007/070811-lumiracoxib.htm


Medicines Regulator cancels registration of anti inflammatory drug,
Lumiracoxib
Media statement 11 August 2007
Australia's medicines Regulator, the Therapeutic Goods Administration (TGA)
has cancelled the registration of the osteoarthritis drug, Lumiracoxib
because of serious liver side effects associated with the use of the drug.
Lumiracoxib, marketed by Novartis Pharmaceuticals under the brand name of
Prexige, is a Cox 2 inhibitor belonging to the group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDS).
Lumiracoxib was first approved in Australia in July 2004 but has only
recently become widely used since being listed on the Pharmaceutical
Benefits Scheme (PBS) in 2006.
According to the TGA's Principal Medical Adviser, Dr Rohan Hammett, as of
10th August 2007 the TGA had received 8 reports of serious liver adverse
reactions to the drug, including two deaths and two liver transplants.
"The TGA and its expert advisory committee, the Adverse Drug Reactions
Advisory Committee (ADRAC), have urgently investigated these reports. ADRAC
has today recommended the cancellation of the registration of Lumiracoxib
due to the severity of the reported side effects associated with this drug,"
Dr Hammett said.
"The TGA has taken this advice to cancel the registration of Lumiracoxib in
order to prevent further cases of severe liver damage.
"It seems that the longer people are on the medicine, the greater the chance
of liver injury. The TGA is, therefore, advising people to stop taking the
Lumiracoxib immediately and to discuss alternative treatments with their
doctor," Dr Hammett said.
Approximately 60 000 people take Lumiracoxib in Australia which is typically
prescribed for: symptomatic relief in the treatment of osteoarthritis,
relief of acute pain, including post-operative pain and pain related to
dental procedures and relief of pain due to primary dysmenorrhoea.
Further information can be obtained by contacting the TGA Info Line on 1800
004 599 (8.30 am-8.30 pm seven days a week), or Novartis Pharmaceuticals on
1800 671 203
Media contact: Kay McNiece, TGA Media Adviser, 0412 132 585

Saludos,
Martin Cañás

GAPURMED
La Plata (Argentina)
macanas en netverk.com.ar