The medication HP Acthar Gel is under scrutiny following the release of data indicating that the drug is linked to high rates of serious adverse events.
On Thursday, July 10, Questcor Pharmaceutical Inc submitted filings to the Securities and Exchange Commission, reporting high levels of adverse events associated with the use of HP Acthar Gel.
These filings state that in the years 2013, 2012, and 2011, 4.8%, 4.9%, and 3.0%, respectively, of patients prescribed Acthar reported having adverse events.
The filings also break down the total number of adverse events as a percentage of prescriptions, with 15.8% of prescriptions in filled 2012 associated with adverse events.
Originally approved by the U.S. Food and Drug Administration (FDA) in 1952, HP Acthar Gel can currently be used in the treatment of 19 different conditions, including systemic lupus erythematosus, proteinuria in nephrotic syndrome, dermatomyositis, rheumatic disorders, and many others.
However, the SEC filings report that, with the exception of the indications for infantile spasms and multiple sclerosis, there have not been any clinical trials to determine efficacy for these treatments.
According to a New York Times investigation, the FDA has received reports of twenty deaths and six disabilities in people who have take Acthar since 2012. Among the adverse effects reported to the FDA’s adverse events reporting system where HP Acthar Gel is suspect, are:
Other side effects reported with HP Acthar include:
The New York Times reports that the SEC is investing Questcor over its marketing practices, and the Wall Street Journal reports that two US Attorneys are also investing the marketing of HP Acthar Gel.
The New York Times points out that the recent increase in reports of adverse events corresponds to the increased marketing of HP Acthar Gel. Between 2001 and 2011, there were 13 deaths reported to the FDA adverse event reporting system, while between 2012 and 2014 there were 20 deaths.
The New York Times also reports that while the adverse event reports have been mounting executives of Questcor have been selling shares in the company.