Canadian health experts are warning about the risk of a severe and potentially life-threatening skin reactions, known as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which have been linked to side effects of the anemia drug Aranesp.
In a safety alert issued earlier this month, Health Canada indicated that Aranesp has been linked to reports of these severe skin reactions, urging doctors to immediately stop treatment with the drug if the conditions are suspected.
Stevens-Johnson Syndrome (SJS) is a serious reaction linked to a number of different drugs, which causes the skin to burn from the inside out, producing blisters, severe rash and often causing the skin to separate from the body. It also often results in vision loss or blindness.
When the skin lesions affect more than 30% of the body, the condition is typically referred to as toxic epidermal necrolysis (TEN), which often results in the need for treatment in a hospital Intensive Care Unit (ICU) or Burn Unit, and the conditions can be fatal in many cases.
According to Health Canada, global safety databases indicate that, as of April 5, there have been at least 11 cases of SJS and four cases of TEN reported among Aranesp patients worldwide. The drug has been exposed to about six million patient-years of use to date.
Health Canada is warning patients to inform their healthcare professional immediately if they begin experiencing Aranesp side effects, and advises doctors to tell a patient to discontinue Aranesp use immediately at the signs of a severe skin reaction or confirmed cases of SJS or TEN. If SJS or TEN is confirmed, that patient should permanently discontinue use of the drug.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of anemia associated with renal failure. It was also approved to treat anemia in patients with chronic kidney disease, who may or may not be on dialysis. Aranesp is also often used to treat patients with HIV and cancer to increase the production of red blood cells and to prepare patients undergoing major surgery, to reduce the number of transfusions necessary during surgery.
In 2012 Amgen, the manufacturer, reached a $762 million settlement to resolve an Amgen whistleblower lawsuit, which alleged the drug maker illegally promoted the medication.
The lawsuit claims Amgen encouraged doctors to use the drugs by overfilling vials by as much as 25 percent. It also alleges the drug company offered doctors discounts to use the drugs in large volume.
Other scandals surrounding the anemia drug involve Amgen offering false information regarding the safety of the drug. The company is reported to continue the use of lobbyists in congress to pressure lawmakers and the FDA to overlook claims of potential severe side effects, such as an increased risk of cancer and stroke.