Europe's regulator has given its support to continued use of Takeda's diabetes pill Actos but has recommended new contraindications and warnings be added to the label regarding a "small increased risk of bladder cancer".
Last month, France and Germany suspended use of Actos (pioglitazone) and Competact (pioglitazone/metformin) following new data from a retrospective study which appears to indicate a slight increased risk of bladder cancer with pioglitazone-containing medicines. However, having completed its review which began in March, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) says medicines containing pioglitazone "remain a valid treatment option for certain patients with type 2 diabetes".
The agency acknowledged the small increased risk of bladder cancer in patients taking these medicines but concluded that it could be reduced "by appropriate patient selection and exclusion, including a requirement for periodic review of the efficacy and safety of the individual patient’s treatment".
Prescribers are advised not to use these medicines in patients with current or a history of bladder cancer or in patients with uninvestigated macroscopic haematuria. They should also consider the age of the patient and review the treatment after three to six months "and regularly afterwards", the EMA added.
The CHMP has also asked Takeda to conduct a pan-European epidemiological study focusing "on more robust characterisation" of the bladder cancer risk. The Japanese drugmaker said it is confident in the therapeutic benefits of pioglitazone and will work with the EMA to implement its proposals.
Last month, the US Food and Drug Administration said it is adding information to the label on Actos about the potential risk of bladder cancer in long-term use.
Champix heart risk study 'not robust'
The EMA has also confirmed that the benefit-risk balance for Pfizer's smoking cessation drug Champix (varenicline) remains positive, despite the results of a recent meta-analysis of its side effects affecting the heart and blood vessels.
The agency has concluded that "the slightly increased risk of cardiovascular events" reported by the study’s authors does not outweigh the benefits of Champix in helping people to stop smoking. The CHMP says it identified a number of limitations of the meta-analysis, including the low number of events seen, and the higher drop-out rates in people receiving placebo, and so "could not draw robust conclusions".
The committee has asked Pfizer to submit a variation to include more information on cardiovascular events in the Champix product information and the drugs giant will submit this application in early August.
Pandemrix narcolepsy link
The EMA has also recommended that in people under 20, GlaxoSmithKline's swine flu jab Pandemrix may only be used if the recommended seasonal trivalent influenza vaccine is not available and if immunisation against H1N1 is still needed.
A review of Pandemrix was initiated to investigate a possible link between vaccination and narcolepsy, following an increased number of cases among children and adolescents in Finland and Sweden, following the H1N1 pandemic vaccination campaign in late 2009 and early 2010. The committee noted that the vaccine is likely to have interacted with genetic or environmental factors which might raise the risk of narcolepsy, but stressed that further research is necessary.
GSK, which says it will conduct the aforementioned research, noted that over 31 million doses of Pandemrix have been administered in 47 countries. Some 335 cases of narcolepsy have been reported, with 68% of them originating from Finland and Sweden.
