Schering-Plough plays down Zetia label change
pharmafile | October 29, 2003 | News story | |Â Â Â
Schering-Plough has changed the labelling of its new cholesterol absorbing drug Zetia after some patients reported experiencing hypersensitivity reactions, including rashes and angio-oedema, a potentially life-threatening swelling of the face, neck, lips and throat.
The drug's side-effects profile has been one of its major selling points and the company only commented on the March 2003 change after reports began appearing in the media.
The company said the label change was a routine update that took into account standard post-marketing surveillance and had not been requested by the FDA.
Zetia's new labelling will note that angio-oedema has been observed in patients who have taken the drug since it was approved, but will not include any other warnings or precautions. All the reported cases of angio-oedema either resolved themselves or were successfully treated.
Zetia was launched in the US by Schering-Plough and its marketing partner Merck in November 2002 and generated sales of $46 million in the first quarter of this year.
The two companies are planning to file a combination of Zetia and Merck's blockbuster statin Zocor for approval later this year. The lucrative combination is aimed at shoring up Zocor's presence in the US market, where it is due to come off patent in 2005 and where the bulk of the drug's sales come from.
Pfizer is using a similar strategy to lengthen the lifecycle of its blood pressure treatment Norvasc (Istin), which is soon to face generic competition, by combining it with its world-leading statin Lipitor.






