Raptiva No Longer Available in CanadaJun 18, 2009 | Parker Waichman LLP
Raptiva has been pulled from the market in Canada because of its association with an often-fatal brain infection called progressive multifocal leukoencephalitis (PML). The suspension of Raptiva sales in Canada is part of a global withdrawal of the drug.
Raptiva works by blocking the activation of certain immune cells called T cells, and the migration of those cells into the skin. However, by suppressing the body’s natural defense system, it can also increase the risk of serious infections and malignancies in patients. Raptiva was authorized in Canada in 2005 for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
In October 2008, U.S. regulators had already mandated that a Boxed Warning be included on the Raptiva label regarding the drugs’ risk of PML and other infectious diseases. In February 2009, the U.S. Food & Drug Administration (FDA) warned that Raptiva had been linked to three fatal cases of PML. The agency also said that it had learned of a suspected PML death in a fourth person treated with Raptiva. That same month, European Medicines Agency said that in light of the deaths, Raptiva’s benefits no longer outweighed its risks, and recommended it be withdrawn from the market in Europe.
It was announced in April that Raptiva was being withdrawn from the global market. The decision was made because the risk/benefit profile for Raptiva had changed. There is no way to determine which Raptiva patients may be at risk for developing PML, and there is also no cure or treatment for the disease.
Raptiva was subject to a voluntary, phased withdrawal, and was no longer available after June 8, 2009. Prescribers in Canada were notified on February 20, 2009 not to issue any new prescriptions for Raptiva and to switch patients to alternative therapies. Pharmacists were also notified on February 24, 2009 not to fill any new prescriptions. Health Canada noted that Canadian prescribers have now had more than 3 months to review the treatment of all patients taking Raptiva and switch them to alternative psoriasis treatments.
According to Health Canada, EMD Serono Canada Inc., the company that markets Raptiva in Canada, notified pharmacies and distribution centers on May 14, 2009 to return all remaining product. Supplies of Raptiva were quarantined on March 11, 2009 and no product has been shipped out since that date.
Health Canada has advised prescribers and other health care providers to continue to monitor carefully all patients that were taking Raptiva, for any signs or symptoms suggestive of PML, and/or other adverse effects.