New warning against EPO preparations: The marketing authorization holders of all human epoetins currently provide information in a Red Hand letter about cases of severe drug-induced skin reactions. Patients should pay attention to the crucial symptoms and signs of skin reactions such as redness and blistering. If this occurs, the treating doctor should be contacted immediately and treatment should be stopped. The affected agents include Retacrit from the manufacturer Pfizer, Eporatio from Ratiopharm and Biopoin from Teva.
Common Red Hand letter from the manufacturers
The marketing authorization holders of all human epoetins are currently providing information in coordination with the European Medicines Agency (EMA) and the Federal Institute for
Drugs and medical devices (BfArM) on the risk of severe drug-induced skin reactions (Severe cutaneous
adverse reactions; SCARs) related to treatment with epoetins. According to the Red Hand letter, the skin reactions would include the so-called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), and some cases were even fatal.
List of affected preparations
A detailed analysis showed that severe drug-induced skin reactions can be regarded as a risk for the class of all epoetins. These include darbepoetin alfa, epoetin alfa, epoetin beta, epoetin theta, epoetin zeta and methoxy polyethylene glycol epoetin beta.
How often the severe skin reactions occurred could not be determined exactly, the authorities are currently assuming a “very rare” adverse drug effect. This means that less than one in 10,000 people are affected. The more severe reactions were documented for long-acting epoetins. The technical information for all medicines containing epoetin is currently being updated.
According to the Rote-Hand-Brief, the following preparations are affected in Germany:
- Aranesp (marketing authorization holder: Amgen)
- Neorecormon and Mircera (Roche)
- Retacrit (Pfizer)
- Silapo (Stada)
- Erypo (Janssen-Cilag)
- Binocrit and Epoetin alfa Hexal (Hexal)
- Abseamed (medice)
- Eporatio (Ratiopharm)
- Biopoin (Teva)
Education about signs and symptoms
Patients should be advised of the following signs and symptoms of severe skin reactions at the start of epoetin treatment: large-scale rash with redness and blistering of the skin and oral mucosa, eye, nose, throat and genital area, including following flu-like symptoms Fever, fatigue, muscle and joint pain. As a result of the rash, the skin can peel off and peel off, similar to a severe burn.
If these signs and symptoms become apparent, the patient should contact their doctor immediately and discontinue treatment with epoetins. Affected people should "never be treated with an epoetin again," the warning said.
Sad celebrity as a doping agent
Industrially manufactured erythropoietin substances (EPO for short) are called “epoetins”. Erythropoietin is a hormone that is mainly produced in the kidneys and promotes the formation of red blood cells (erythrocytes). Accordingly, EPO is used in medicine for the treatment of anemia, for example in the case of severe renal insufficiency and dialysis patients.
EPO achieved unpleasant fame as a doping agent: Since the muscles can be better supplied with oxygen by the agent, many athletes hoped for increased endurance and increased physical performance. The best-known case is probably the cyclist Lance Armstrong, who had to give up all seven titles again after his doping scandal.
EPO can minimize the risk of brain damage
Swiss researchers, on the other hand, made a very gratifying discovery a few years ago. They realized that the EPO doping agent 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 immediately after birth, the cerebral lesions could be significantly reduced, the scientists from the University of Geneva said. (No)