What Consumers Should Know about H.P. Acthar Gel
News recently broke that Questcor Pharmaceuticals had disclosed to its investors that its popular H.P. Acthar Gel had numerous reports of adverse events associated with the product. The product, an injectable solution used to treat a variety of immune and inflammatory disorders, has been around for literally decades. Here’s what consumers need to know about Acthar.
What is Acthar Gel?
The website for Acthar explains that acthar gel is a repository corticotropin injection that is currently approved by the FDA to treat 19 different indications including: infantile spasms, rheumatoid arthritis, stevens-johnson syndrome, multiple sclerosis, sarcoidosis, lupus, serum sickness, and more.
The product is a porcine-derived hormone.
History of Acthar
According to a brief history of the drug, Acthar gel was first approved by the U.S. Food and Drug Administration (FDA) in 1952. At that time, extensive clinical trials were not required for drug approval. Although the product was initially approved by the FDA to treat a range of disorders, its use was limited in 1977 and continued popularity until the 1980s.
Questcor purchased the rights for Acthar gel in 2010 and in 2006 filed a supplemental new application to add infantile spasms as an indication. Questcor obtained approval in 2010 and received orphan drug status which allowed the company seven years of market exclusivity.
Since its first approval to present day, the price of one vial of Acthar has risen from $40 to $28,000.
Independent Lab Questions Acthar Ingredients
Earlier this year, an independent lab tested the ingredients of H.P. Acthar and concluded the ingredients were not in fact what the product labeling indicated. The results were forwarded to the FDA, who has since launched an investigation into the product. Those results are not yet available.
Questcor Discloses Adverse Events
Last week, Questcor disclosed in an SEC filing that the number of adverse events reported had risen from about 9.1 percent of prescriptions in 2011 to almost 14 percent in 2013. Specifically, 1,022 patients reported a total of 3,100 adverse events between 2011 and 2013. The adverse events reported included abdominal pain, increased blood sugar, and renal failure.