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The Pulse of the Pharmaceutical Industry
August 17, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Sales of GlaxoSmithKline (GSK)’s popular over-the-counter weight-loss drug Alli have waned over the past few years. The drug could take another loss following a new report that adverse effects such as diarrhea or incontinence were understated by the company during clinical trials.
The report was published this week in the Danish journal PLOS Medicine. In the article, the researchers compared journal articles about Alli, which was first approved as a prescription drug, Xenical (oralist), developed by Roche (RHHBY), to data summaries submitted to European regulators, StatNews reported this morning. Under their review, the researchers found the publications only revealed 14 to 33 percent of the adverse effects. As an example, two of the publications did not reveal side effects that occurred in less than 5 percent of trial participants. The report also shows that multiple reports from one patient was only reported as one adverse effect.
In their conclusion, the researchers said they identified “important disparities in the reporting of adverse events between protocols, clinical study reports, and published papers” when it comes to oralist trials. The researchers said the findings of their study reveal the underreporting of the effects “understated harms in the summarised (sic) results submitted to the EMA (European Medicines Agency) for drug approval and in the published papers.
“Based on the characteristics of harms observed and reported in these trials, we suggest that reports of harms include duration of adverse effects,” the researchers said. “We also suggest that systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles.”
A Roche spokesperson told StatNews that trial reporting was “done according to the standards of the time.” A GlaxoSmithKline spokesperson told the news organization that the company takes “adverse event reporting for our products very seriously and routinely monitor[s] safety information in conjunction with health care professionals and regulatory agencies worldwide.”
Alli works by preventing the body from absorbing fat. However, by not absorbing the fat, it often means those who take it have oily discharge, which can lead to some gastrointestinal side effects, StatNews said.
Over the course of its use, users of the prescribed Xenical declined annually, with multiple patients stopping use within a year.
In 2010, the U.S. Food and Drug Administration added a warning to both the prescription version and the over-the-counter Alli that cautioned about reports of possible, albeit rare, liver damage.
Venical is no longer sold in the United States and GSK no longer includes Alli sales in its financial reports, StatNews said.
Sorry. No data so far.