FDA launches investigation into GlaxoSmithKline’s Zofran

18 September 2011 (Last Updated September 18th, 2011 18:30)

The US Food and Drug Administration (FDA) has launched an investigation into GlaxoSmithKline's Zofran medication, used to treat nausea, following concerns that the drug could distort the electrical activity of the heart. The investigation, which will also include generic versions of t

The US Food and Drug Administration (FDA) has launched an investigation into GlaxoSmithKline’s Zofran medication, used to treat nausea, following concerns that the drug could distort the electrical activity of the heart.

The investigation, which will also include generic versions of the drug, is focused around active ingredient ondansetron.

It is feared that the ingredient could cause QT interval prolongation, potentially leading to abnormal heart rhythms.

The FDA has acted quickly to enforce an interim change to the labelling on products within the US market that contain ondansetron, and has also requested that GlaxoSmithKline to conduct a study to assess Zofran’s potential in prolonging the QT interval.

Zofran was once considered integral to GlaxoSmithKline’s performance, but the drug has lost importance with the advent of generic competition.