Interneuron May Modify Label Of Redux to Reflect Side Effect
April 26, 2011
LEXINGTON, Mass. -- Interneuron Pharmaceuticals Inc. said it may be required to modify the label of its Redux obesity drug to show potentially higher incidence of a rare side effect. The company's stock dropped 8.5% on the news. But a scientist familiar with the research said the changes will likely be minor. The side effect is primary pulmonary hypertension, a rare but serious lung disorder. In its quarterly filing with the Securities and Exchange Commission, Interneuron disclosed that a scientific team is expected to publish a report that estimates incidence of the rare lung disorder in patients who take antiobesity drugs will be ``higher than the occurrence rate originally reported.'' The company's stock closed at $24.25, down $2.25 in Nasdaq Stock Market trading Tuesday. Researchers involved in the study, including scientists at McGill University in Canada, couldn't be reached. But Marcelino Maxfield, medical director at Wyeth-Ayerst Laboratories in Radnor, Pa., a division of Redux marketer American Home Products Corp., said he is familiar with the upcoming publication and believes the difference will be so small as to be ``insignificant.'' The lung disorder was a major issue during the Food and Drug Administration review of Redux. Its incidence among people who take antiobesity drugs will be estimated in the published report as 23 to 46 people per million, compared with the 18 people per million originally estimated in data reviewed by the FDA, said Dr. Maxfield. Incidence in the general population is one to two people per million.
