New drug warning Epoetins can cause severe skin reactions

New warning against EPO preparations: The authorization holders of all human Epoetins are currently informing in a Red Hand letter about cases of serious drug-induced skin reactions. Patients should be alert to the critical symptoms and signs of skin reactions such as redness and blistering. If these occur, the treating physician should be contacted immediately and the treatment discontinued. Among the products concerned are Retacrit from the manufacturer Pfizer, Eporatio from Ratiopharm and Biopoin from Teva.

Joint red-hand letter from the manufacturer

The authorization holders of all human epoetins are currently informing in coordination with the European Medicines Agency (EMA) and the Federal Institute for Health
Medicines and Medical Devices (BfArM) on the risk of severe drug-induced skin reactions (Severe Cutaneous
adverse reactions; SCARs) associated with treatment with epoetins. According to the Rote-Hand-Brief, skin reactions would include the so-called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases were even fatal.

The marketing authorization holders warn that treatment with human epoetins in very rare cases can lead to serious drug-induced skin reactions. (Image: Cherries / fotolia.com)

List of affected preparations

A detailed analysis has shown that severe drug-induced skin reactions can be considered a risk to the class of all epoetins. These include darbepoetin alfa, epoetin alfa, epoetin beta, epoetin theta, epoetin zeta and methoxy-polyethylene glycol-epoetin beta.

The frequency with which severe skin reactions have occurred has not been determined accurately, with authorities currently expecting a "very rare" adverse drug reaction. This means that less than one in 10,000 people are affected. The more severe reactions were documented for long-acting epoetins. Currently, the technical information of all epoetin-containing medicines is updated.

According to the Rote-Hand-Brief, the following products are affected in Germany:

• Aranesp (holder of authorization: Amgen)
• Neorecormone 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 when starting to receive epoetin preparation: Large rash and blistering of the skin and oral mucosa, ocular, nasal, cervical and genital areas following flu-like symptoms including 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, patients should contact their doctor immediately and discontinue their treatment with epoetins, according to the notification. Affected individuals may also "never be treated with an epoetin again," the warning said.

Sad celebrity as a doping agent

"Epoetins" are industrially produced erythropoietin substances (EPO for short). 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 anemia, for example in severe renal insufficiency and dialysis patients.

Unfortunate celebrity gained EPO as a doping agent: Since the muscles can be better supplied with oxygen by the means, many athletes promised an increased endurance and increase in physical performance. The most famous case is probably the cyclist Lance Armstrong, who had to give up all seven titles again after his doping scandal.

EPO can minimize risk of brain damage

On the other hand, Swiss researchers made a very pleasing discovery a few years ago. They realized that the EPO doping agent protects premature babies' brains. These have a significantly increased risk of brain damage compared to children born "mature". Treating premature infants with EPO immediately after birth may significantly reduce cerebral lesions, researchers from the University of Geneva said. (No)