Anapen (Epinephrin)
Anapen (active ingredient: epinephrine) has been approved for the treatment of a state of shock (anaphylactic emergency) in some European member states, including Austria, since 2005.
Recently, during the further development of the product, a quality defect was discovered, according to which the epinephrine solution is not or not sufficiently delivered in an anaphylactic emergency. In the event of actual use, this would not result in successful treatment of the shock condition. Since 2001, about four million units have been sold, about 26,000 units have been subjected to the company's internal quality control, but this has not occurred in any case of a product on the market. Therefore, this product recall is purely precautionary.
Measures at EU level
Depending on the availability of an alternative product on the respective market, the drug was either recalled or a warning was issued in the member states.
Situation in Austria
In Austria, the following preparations are affected by the recall
- Anapen 300 microgram in 0.3 ml - solution for injection (prefilled syringe)
- Anapen Junior 150 microgram in 0.3 ml solution for injection (ready-to-fill syringe)
BASG has not received any adverse reaction or quality defect reports for the preparations.
Recommendation of the BASG
There is no reason for uncertainty, however, should you wish to consult this product, please talk to your attending physician. The share of Anapen on the Austrian market is about 4.6 percent. Alternative products are approved.
Further information:
BASG safety letter, 05.06.2012.
Queries (technical):
Institute Monitoring Dipl.-Ing. Dr. Ronald Bauer E-mail: ronald.bauer@ages.at
