Pfizer voluntarily withdraws Bextra from NZ

Media Release
11 April 2005

Pfizer voluntarily withdraws Bextra from New Zealand market

Pharmaceutical company Pfizer is voluntarily withdrawing the Cox-2 medicine Bextra from the New Zealand market following a request from Medsafe to suspend distribution and marketing, and will recall supplies of Bextra progressively from wholesale and pharmacy shelves over the next few days.

Medsafe Principal Technical Specialist Dr Stewart Jessamine said Pfizer today informed Medsafe it would be voluntarily withdrawing Bextra (valdecoxib), following similar withdrawals in the US, Europe and Canada.

Along with other Cox-2 inhibitors, the safety of Bextra is already under review due to concerns about possible cardiovascular risk, (heart attack or stroke), when taking these products.

In the past week the United States Food and Drug Administration (FDA) has expressed the opinion that the risks of using Bextra outweigh its benefits because Bextra has similar cardiovascular risks as other Cox-2 medicines and a higher risk of serious adverse skin reactions. Following this announcement Medsafe, along with other regulators, asked Pfizer to voluntarily suspend distribution and marketing Bextra from the market to allow further review of the risk:benefit of this product.

The voluntary withdrawal will commence this week and will remain in place at least until after the Medicines Adverse Reaction Committee (MARC) reviews data on serious cutaneous adverse reactions associated with use of Bextra at its June meeting. Medsafe will consider the MARC's recommendations about Bextra and skin reactions before it makes its final decision.

Dr Jessamine said: ``The MARC remain very concerned about the safety of the Cox- 2 inhibitors and stand by its earlier advice on this group of medicines. Due to the increased level of concern about Bextra, Medsafe is advising people taking this medicine to make an appointment to see their doctor at their own convenience to discuss stopping Bextra and changing to another treatment option while awaiting the outcome of this extended review.''

Medsafe's final decision on the cardiovascular safety of the class of Cox 2 inhibitors, to which Bextra belongs, should be known later this month.

Background information
Pfizer comment on the US withdrawal of Bextra: http://www.bextra.com/
FDA announcement of US withdrawal of Bextra: http://www.fda.gov/bbs/topics/news/2005/NEW01171.html

Questions and answers about Bextra from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)
http://www.mhra.gov.uk/news/bextraqanda.pdf

Medsafe advice to Doctors and Pharmacists February 2005: http://www.medsafe.govt.nz/hot.htm

Ministry of Health statement 22 February: http://www.moh.govt.nz/moh.nsf/bfc540e5ac1ab e02cc256e7d0082eede/a91b805c1d6b0560cc256fb0000308a5?OpenDocument

ENDS

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