Data Links 20 Deaths to Acthar
In a regulatory filing submitted to the U.S. Securities and Exchange Commission (SEC) on Thursday, Questcor revealed that adverse events were reported in connection with 14 percent of all Acthar prescriptions filled in 2013, marking a 5 percent increase from the adverse event rate recorded in 2011. The company did not, however, comment on data indicating that 20 deaths and six disabilities have been linked to the drug since 2012.
20 Deaths Reported Since 2012
In last week’s filing, Questcor acknowledged that 1,022 patients using Acthar had reported 3,100 adverse events between January 1, 2011 and December 31, 2013. Along with this data, Acthar released a statement claiming that many of the patients treated with Acthar are seriously ill and are facing life-threatening health risk.
What the filing failed to address was data obtained by the New York Times under the Freedom of Information Act which indicates that at least 20 deaths and six disabilities have been reported to the U.S. Food and Drug Administration (FDA) since 2012. In these reports, Acthar was listed as “suspect,” meaning Acthar was most likely associated with the events.
This data is the latest in a series of controversies involving Questcor and Acthar. Last month the FDA announced that it was reviewing accusations that Acthar’s label does not accurately reflect the drug’s ingredients.
Questcor is also under investigation by the SEC over its marketing practices.
Acthar is currently approved for 19 indications, and a single five-milliliter vial of the drug can cost $28,000 – up from $1,650 per vial in 2007. The drug makes up roughly 96 percent of Questcor’s revenues.
Acthar Side Effects
The following adverse events have been reported to the FDA in connection with Acthar
- Heart Failure
- Bone Marrow Failure
- Renal Failure