Drug safety organizations in New Zealand and Australia have also been struggling with the best way to handle the steady stream of concerns over the safety of Pradaxa.
In New Zealand, drug safety is monitored by the Ministry of Health, which in turn contracts with the Centre for Adverse Reactions Monitoring (CARM) to monitor adverse event reports relating to medications. Both patients as well as healthcare providers can make adverse event reports involving drug-induced injuries, much like in the United States.
The approval of Pradaxa in New Zealand was particularly controversial. Pharmac, the government agency that pays for medications and establishes a formulary, heralded the approval of Pradaxa and made it available with virtually no limitations or warnings to doctors throughout New Zealand, even in the face of reports that the drug might cost the country $150 million. Within months, however, the press in New Zealand was highly critical of Pharmac’s enthusiasm for Pradaxa when two patients died and dozens were injured within months of the drug’s approval. There was also evidence of a lack of appreciation by physicians and patients of the substantial risks posed by Pradaxa as well as evidence that the drug had been prescribed inappropriately to at-risk patients, including those with pre-existing kidney disease as well as patients 75 and older.
On September 30, 2011, the Pharmaceutical Benefits Advisory Committee (PBAC) and the Australian government announced that it was commissioning a safety review of Pradaxa. The PBAC is an advisory committee comprised of doctors, healthcare professionals and consumers which makes recommendations regarding drugs to be included in their national prescription drug program. Pradaxa was recommended for inclusion on the list in March of 2011 for the prevention of stroke or systemic embolism in patients with atrial fibrillation that was not the result of valvular heart disease. The advisory committee’s commendation of this expanded use of Pradaxa, however, was not without some reservations. The advisory committee requested additional investigation into whether Pradaxa really provides a benefit over warfarin (and more specifically whether there is evidence of a benefit when the patients in the study group are given the correct dosage of warfarin, take their Coumadin correctly, and whether the benefits relied upon by Pradaxa’s manufacturer apply to all patients). The Australian press release regarding Pradaxa indicated that approval of the drug in Australia would result in approximately $1 billion in sales of the anticoagulant to Australian patients, such that the government had a strong desire to ensure that such a costly drug was truly beneficial to a broad category of patients in addition to being safe for use by patients.
Australian regulators approved a Consumer Medicine Information guide for patients taking Pradaxa that is very informative. The guide includes dosing instructions for various categories of patients for whom use of Pradaxa is approved in Australia, including prescriptions for patients who have undergone recent hip or knee implant surgeries and for the prevention of strokes in patients with atrial fibrillation. The Patient Safety Guide alerts consumers to contact their physician immediately if they suffer any symptoms that may be consistent with a potentially-fatal bleeding event caused by the drug, including: bruising, nosebleeds, fatigue, shortness of breath, nasal pain, chest pain, swelling of hands or feet, red or dark brown urine, active bleeding, or red or black bowel movements.