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GlaxoSmithKline and Valeant’s experimental epilepsy drug Potiga is effective at preventing seizures but causes urinary problems in a small number of users, US health regulators have ruled.
A Food and Drug Administration (FDA) advisory panel said 5% of trial participants taking Potiga experienced bladder problems, compared with 3% of those on placebo.
“Urinary retention appears to be a significant safety issue for Potiga,” the group said.
The drug, however, also reduced the number of seizures by between 23% and 44% depending on dose strength. Patients on placebo experienced reductions of between 13% and 18%.
Both Glaxo and Valeant are hopeful that the problem can be tackled by means of patient monitoring.
In a memo to the panel, Dr Russell Katz, director of the FDA’s neurology drugs division, said data “clearly establish (Potiga’s) capacity to produce urinary retention that in most, though not all, cases was shown to be reversible.”
Copyright Press Association 2010