New information on Herceptin theft
Situation Austria: currently only parallel marketed Italian Herceptin and Alimta are affected (as of 18.4.2014).
The drug Herceptin is approved throughout Europe for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. It is used primarily in hospitals, contains the active ingredient trastuzumab, and is available as 150 mg powder for the preparation of an infusion solution concentrate for intravenous administration or as 600 mg/5 ml injection solution for subcutaneous administration. Suspicions of counterfeiting are currently limited to the intravenous dosage form only.
The drug Alimta is approved throughout Europe for the treatment of lung cancer. It is used under the supervision of physicians experienced in the use of antineoplastic drugs. Alimta is a powder prepared for infusion and administered intravenously. It contains the active ingredient pemetrexed.
Remicade is approved throughout Europe as an anti-inflammatory drug and is used to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. It contains the active ingredient infliximab and is a powder prepared for infusion. It is used by qualified physicians experienced in the diagnosis and treatment of the above diseases.
Measures at EU level
The European Medicines Agency (EMA) is providing the latest information regarding stolen Herceptin (trastuzumab) vials in Italy. The vials were adulterated and introduced into the legal distribution chain in some countries. Italian law enforcement authorities are currently investigating the theft, but the incident affects the entire EU. These are exceptional circumstances caused by criminal activity that require special measures and require close cooperation between all EU health authorities.
National health authorities are currently trying to identify all affected batches in their countries as quickly as possible and are already taking appropriate steps to avoid any health risk to patients. In addition to the theft investigation, all piercing vials are being recalled from the products and batches already identified. In addition to Herceptin affected by the theft, there is now such confirmation for Alimta (pemetrexed) and Remicade (infliximab) products. Samples of the batches affected by the theft are currently being analyzed. It must be noted, however, that to date no adulterated Alimta or Remicade vials have been found that have already been distributed. It is assumed that only a small number of vials of the three drugs are affected by the adulteration and there have been no reports of patient harm to date. It is believed that the precautionary recall actions initiated will not result in any distribution restrictions.
Users and pharmacists are again asked to pay special attention to the three drugs before use/preparation. If one of the products mentioned appears suspicious, the BASG / AGES Medizinmarktaufsicht should be informed as soon as possible.
For this purpose, it is again pointed out to check the following characteristics in order to be able to detect possibly counterfeit vials of Herceptin, Alimta and Remicade:
- Lot number and expiration date on the vials do not match the information on the outer packaging.
- Some vials contained a liquid (Herceptin is a white to faint yellow lyophilized powder)
- Tampered with rubber stoppers, crimp caps and caps.
- The counterfeit vials are circulating as Italian Herceptin 150 mg
Counterfeit drugs should not be used under any circumstances, as it must be considered that they are not safe or effective.
The following information regarding affected lots is currently available:
| Affected Batches (Herceptin)(As of: 18.04.2014) |
|---|
| H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09, H4303B01, H4143B01, H4293B01, H4180B01, N1010B02. |
The Paul Ehrlich Institute in Germany also reported additional parallel distributed Herceptin batches of Italian origin that were not legally introduced into the distribution chain.
| Affected batches (Herceptin, Paul-Ehrlich-Institut) (as of 04/18/2014). |
|---|
| H4105B01, H4136B02, H4150B01, H4152B04, H4168B02, H4169B01, H4171B01, H4179B02, H4184B01, H4185B02, H4194B01, H4195B01, H4261B01, H4263B02, H4279B01, N1001B01, N1002B02, N1002B03 |
| affected batches (Alimta) (as of 04/18/2014). |
|---|
| C134092E, C021161E, C160908C |
| affected batches (Remicade) (as of 04/18/2014). |
|---|
| 3RMA66304, 3RMA67102, 3RMA68106, 3RMA67602 |
Situation in Austria The following proprietary medicinal products are approved in Austria:
- Herceptin 150 mg powder for the preparation of an infusion solution concentrate.
- Herceptin 600 mg/5 ml solution for injection
- Alimta 100 mg powder for the preparation of a concentrate for infusion solution
- Alimta 500 mg powder for the preparation of a concentrate for solution for infusion
- Remicade 100 mg powder for a concentrate for solution for infusion
Please note that currently only "Herceptin 150 mg Powder for the Preparation of a Concentrate for Solution for Infusion" has been identified as counterfeit. So far, no evidence of adulterated vials has been found for Alimta and Remicade, but they are also affected by the theft in Italy.
Batches marketed by the marketing authorization holders in Austria are not affected.
In Austria, Italian Herceptin has been distributed exclusively by the two parallel distributors "HAEMATO PHARM GmbH" and "INOPHA GmbH". A recall of the batches affected in Austria (H4196B01, H4271B01, H4284B04, H4303B01, H4301B09, H4324B03, H4329B01) has been initiated. The recall of another Herceptin lot (H4143B01) was also initiated.Furthermore, a recall of the batches reported by the Paul Ehrlich Institute and affected in Austria (H4150B01, H4152B04, H4169B01, H4171B01, H4179B02, H4194B01, H4261B01, H4263B02, H4279B01, N1001B01, N1002B02, N1002B03) has been initiated.
In Austria, Italian Alimta has been distributed exclusively by the two parallel distributors "HAEMATO PHARM GmbH" and "INOPHA GmbH". A recall of the batches affected in Austria (C134092E, C021161E, C160908C) has been initiated.
However, according to current information, noItalian Remicade from the affected batches is distributed in Austria via parallel distribution, so that no recall has been initiated here at present.
In the period from January 2013 to April 2014, the BASG received a total of 26 adverse event reports for Herceptin from Austria. However, no conclusion can be drawn regarding a connection with the use of adulterated "Herceptin 150 mg powder for the preparation of an infusion concentrate".
Recommendations of the BASG Recommendations for users and pharmacists:
- Please check the above listed adulteration characteristics before using/preparing the above products.
- If a possible counterfeit is detected, we request that you report it to the Medical Market Surveillance of the Institute Surveillance of BASG / AGES Medical Market Surveillance at enforcement@ages.at.
- Please check your stock for the mentioned products with origin Italy and compare them with the affected batch numbers already identified for Austria as well as those identified throughout Europe and do not use them anymore.
Recommendations for patients:
- If you have any questions, please contact your physician
Further information: European Medicines Agency press release (04/17/2014):
European Medicines Agency press release (16.04.2014):
Safety release of the BASG (18.04.2014): see below"Files".
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004 E-mail: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
