Worldwide Bextra recall begins

In line with the FDA announcement on Bextra recall in the United States, and as expected, Health Canada, the equivalent government body in Canada, has asked Pfizer Canada to voluntarily discontinue sales of Bextra in Canada until safety issues have been resolved. According to an announcement by Health Canada, Pfizer has agreed and will be discontinuing sales immediately in Canada. (Related article: Complete coverage of Bextra recall)

In most cases, Health Canada (like many other drug agencies worldwide) follows the decisions of the FDA but in some cases, for instance, Adderall recall, Health Canada went ahead despite resistance, and even pressure, from the FDA. Health Canada continues to stand by its decision while FDA has refused to act.

Health Canada has further asked Pfizer to submit evidence to establish the safety of Bextra under the conditions of use for which it is recommended. In addition Pfizer has been asked to provide Health Canada with a risk/benefit analysis indicating Bextra's unique therapeutic advantage. (Related article: Bextra safety doubted in two studies)

Similarly, the European Medicines Agency (EMEA), the drug regulatory agency in Europe has also directed Pfizer to recall Bextra in Europe. In the ongoing review of Cox-2 inhibitor drugs, Europeans have been more careful and have imposed stronger restrictions on their prescriptions than the United States. An EMEA panel is scheduled to meet later this month and may impose further restrictions on other Cox-2 drugs like Arcoxia (Etoricoxib), Prexige or Dynastat (Parecoxib), Mobic (Meloxicam), and others.

Drug regulatory agencies in Australia, Singapore, and New Zealand have already restricted Bextra and Celebrex prescriptions and as the decisions are made over the next few days, formal announcements are expected soon. Essentially in almost all cases, patients are being asked to discontinue taking Bextra and speak to their doctor immediately. Other guidelines are identical to those provided by the FDA.

In India, where Bextra is not sold but Indian companies market generic versions of valdecoxib, doctors are already switching their patients to other drugs. The Drugs Controller General of India (DCGI), Ashwini Kumar, told an Indian newspaper the Economic Times that the process of reviewing the drug has been initiated and a decision is expected soon.

Regarding refunds for unused Bextra pills, if you live in the United States, you may bring them to your local pharmacy and request a refund. Or you may contact the National Notification Center (NNC) at 1-866-608-3935 to receive a patient product return kit by mail. NNC will process the refund on Pfizer's behalf. While both FDA and Pfizer are asking arthritis patients to talk to their doctors, it is also possible to call the BEXTRA Customer Support Center at 1-866-623-9872. In countries outside the US, you must contact the local office of Pfizer or your pharmacy where you purchased the drug.

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