Joint red-hand letter from the manufacturers
The authorization holders of all human epoetins are currently informing about the risk of serious drug-induced skin reactions( Severe cutaneous
adverse reactions) in coordination with the European Medicines Agency( EMA) and the Federal Institute for
Drugs and Medical Devices( BfArM), SCARs) associated with treatment with epoetins. The skin reactions would include the so-called Stevens-Johnson syndrome( SJS) and the toxic epidermal necrolysis( TEN), according to the Red Hand letter, and some cases were even fatal.
List of affected products
A detailed analysis showed that severe drug-induced skin reactions can be considered as a risk to the class of all epoetins. These include darbepoetin alfa, epoetin alfa, epoetin beta, epoetin theta, epoetin zeta and methoxy-polyethyleneglycol-epoetin beta.
How often the severe skin reactions occurred could not be determined precisely, the authorities are currently assuming a "very rare" unwanted drug effect. This means that less than one in 10,000 people are affected. The more severe reactions were documented for long-acting epoetins. At present, the specialist information for all epoetin-containing medicines is being updated.
In Germany, according to the red-hand letter, the following preparations are affected:
- Aranesp( holder: Amgen)
- Neorecormon and Mircera( Roche)
- Retacrit( Pfizer)
- Silapo( Stada)
- Erypo( Janssen-Cilag)
- Binocrit andEpoetin alfa Hexal
- Biopoin( Teva)
Information about Signs and Symptoms
Patients should be enrolled at the start of treatment with an epoetin preparation for the following signs and symptoms of severe skin reactions: Large areaRash with redness and blistering of the skin and oral mucosa, eye, nose, throat and genital area following flu-like symptoms including fever, fatigue, muscle and joint pain. As a result of the rash, the skin can peel off and detach itself - similar to a heavy incineration.
If these signs and symptoms become apparent, patients should immediately contact their physician and discontinue treatment with epoetins. Patients who are affected should never be treated with an epoetin again.
Sad celebrity as doping agent
"Epoetins" are industrially produced erythropoietin substances( EPO).Erythropoietin is a hormone that is mainly produced in the kidneys and promotes the formation of red blood cells( erythrocytes).In medicine, EPO is used accordingly for the treatment of blood glut( anemia), for example in severe renal insufficiency and dialysis patients.
Unpleasant celebrity gained EPO as doping agent: As the muscles can be supplied with oxygen better by the medium, many athletes promised an increased endurance and increase of the physical performance. The best known case is probably the cyclist Lance Armstrong, who had to surrender all seven titles after his doping scandal.
EPO can minimize the risk of brain damage
Swiss researchers, on the other hand, made a very pleasing discovery a few years ago. They recognized that the EPO dopant protects the brain of premature babies. These have a significantly increased risk of brain damage compared to children who are born "mature".If premature babies are treated with EPO directly after birth, the cerebral lesions could be significantly reduced, the scientists of the University of Geneva reported.(nr)