To ask the Secretary of State for Health, what information his Department holds on how many people have experienced adverse health effects as a result of using the drug ruxolitinib.
Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The Yellow Card Scheme collects information relating to suspected adverse drug reactions, which include both serious and non-serious effects which a health care professional or patient suspect may have been due to a medicine.
The MHRA has received a total of 74 United Kingdom spontaneous suspected ADR reports in association with ruxolitinib up to and including 10 February 2015. This number includes reports received directly from healthcare professionals, patients and indirectly through pharmaceutical companies which have a legal obligation to report suspected ADRs.
The inclusion of a particular ADR in a report does not necessarily mean it has been caused by the drug, only that the reporter had a suspicion it may have, or it had a close temporal relationship to the administration of the suspect drug. The fact that symptoms occur after a treatment does not necessarily mean that they have been caused by the drug itself, as underlying illnesses and other conditions may be responsible.
In 2013, the product information for ruxolitinib was updated to warn healthcare professionals that cases of progressive multifocal leukoencephalopathy (PML) have been reported with ruxolitinib and to recommend that patients are monitored at regular intervals for any new or worsening neurological symptoms or signs. The Market Authorisation Holder is currently conducting studies to investigate the risk of PML further. The benefits of ruxolitinib to adult patients with myelofibrosis who have an enlarged spleen or symptoms related to the disease are considered to outweigh the risks.