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Acthar

14% of Acthar Prescriptions Linked to Adverse Events

H.P. Acthar Gel (Acthar) is a medication containing a highly purified preparation of the adrenocorticotropic hormone and is approved for the treatment of 19 different inflammatory and autoimmune disorders.

However, Questcor Pharmaceuticals, the developer of Acthar, has released information indicating that roughly 14 percent of all prescriptions filled in 2013 resulted in adverse events.

20 DEATHS REPORTED TO THE FDA

In July 2014, Questcor released a filing with the SEC indicating that adverse event rates linked to Acthar prescriptions had increased from 9.1 percent in 2011 to 14 percent in 2013. Further, the company disclosed that 1,022 patients reported 3,100 adverse events between January 2011 and December 2013.

What Questcor did not include in their report were the 20 deaths and 6 disabilities that had been reported to the U.S. Food and Drug Administration (FDA) since 2012.

Acthar is also facing scrutiny from UnitedHealth who alleges that the drug is “not medically necessary” for four of its last five approved indications.

SIDE-EFFECTS OF ACTHAR

The following adverse events have been reported in patients taking Acthar:

  • Hypertension
  • Heart Failure
  • Convulsion
  • Nausea
  • Renal Failure
  • Pneumonia
  • Thrombocytopenia
  • Bone Marrow Failure
  • Death
APPROVED INDICATIONS

Acthar is currently approved to treat the following disorders:

  • Systemic Lupus Erythematosus
  • Multiple Sclerosis Relapse
  • Proteinuria in Nephrotic Syndrome
  • Infantile Spasms
  • Dermatomyositis and Polymyositis
  • Respriatory Manifestations of Symptomatic Sarcoidosis
  • Severe Erythema Multiforme
  • Stevens-Johnson Syndrome
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Serum Sickness
  • Keratitis
  • Iritis
  • Diffuse Posterior Uveitis and Choroiditis
  • Symptomatic Sarcoidosis

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