Questcor Discloses Rising Reports of Acthar Side Effects
Questcor purchased Acthar in 2001 for $100,000. The drug now sells for nearly $28,000 per five-milliliter vial and generates about 95 percent of Questcor’s revenue.
While Questcor has been quick to highlight the drugs benefits for its 19 indications, a new report released by the company to investors suggests that the drug is linked to serious and sometime fatal side effects. Even worse, these events are increasing in frequency.
In 2011, the Supreme Court ruled that pharmaceutical companies are responsible for informing investors of all adverse events, even if the events are rare. However, it appears that before this latest report, Questor has made little effort to notify investors of Acthar's reported side effects.
Further complicating matters are allegations by the U.S. Food and Drug Administration that Achtar’s label did not provide a complete list of ingredients. Questcor is also being investigated by the Securities and Exchange Commission (SEC) for its marketing practices.
Details Released in the Acthar Report
- According to the New York Times, from January 1, 2011, to December 31, 2013, 1,022 patients reported 3,100 adverse effects in connection with Acthar.
- An indepentdent investigation by the times also found that from Jan. 2000, to Dec. 2011, 13 deaths involving Acthar were reported to the FDA.
- Since 2012, 20 deaths and six disabilities were reported. These events listed Acthar as the “suspect” drug meaning that Acthar was determined to be the drug most likely linked to the incidents. These events were not addressed by Questcor in their report.
- Other events reported by patients taking Acthar include:
- Cardiac failure
- Renal failure
- Bone marrow failure
- Stevens-Johnson syndrome