Questions and answers about counterfeit drugs Herceptin, Alimta and Remicade
Which drugs are affected?
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 and contains the active ingredient trastuzumab. It is available as 150 mg powder for preparation of an infusion solution concentrate for intravenous administration and as 600 mg/5 ml solution for injection for subcutaneous administration. According to current information, only the intravenous dosage form (150 mg powder for preparation of an infusion solution concentrate) is affected by the counterfeit case. 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. It is available in 100 mg and 500 mg strengths. According to current information, only the larger strength (500 mg powder for the preparation of a concentrate for infusion solution) is affected by the counterfeit case. The preparation Remicade is approved throughout Europe as an anti-inflammatory drug and is used for the treatment of 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 who are experienced in the diagnosis and treatment of the above diseases. In contrast to other EU countries, according to current information, Austria is not affected by the counterfeiting case with regard to Remicade.
How were the affected drugs counterfeited?
In the case of Herceptin, the original drug was supplied to hospitals by the marketing authorization holder Roche in Italy. There is a suspicion that these original drugs were stolen from the hospitals - several hundred packages were reported as stolen to the Italian authority AIFA. Furthermore, it is suspected that these packages were passed on to parallel distributors abroad with falsified documents, and were in turn distributed to hospitals via these distributors. Parallel distribution/importation is a legally covered and controlled procedure by which medicinal products may be acquired or traded in the free movement of goods in the EU.
Suspicions indicate that documents were falsified purporting that Italian goods were purchased and distributed by foreign wholesalers. However, these foreign wholesalers were presumably never in possession of these goods, nor did they actually distribute them.
Similar facts have also been reported for the products Alimta and Remicade.
Is there a risk for patients?
According to current information, the probability that a patient in Austria is actually affected is rather low. The annual demand for Austria is about 35,000 packs, in contrast, the packs affected and potentially impacted by the recall represent less than 5% of this quantity.
In a very small number of the affected packs, the products have been tampered with, so there is no guarantee that these products actually contain the correct active ingredient in the stated quantity or whether they contain any active ingredient at all. In individual cases, it was proven that no active ingredient was contained, or that the active ingredient content was only 7%. In addition, a small number of vials were found to have been tampered with, e.g. damaged crimp caps or punctured rubber stoppers, in some cases a liquid was found in the vials instead of the dry powder, or a different active ingredient, namely a widely used antibiotic, was found instead of the correct active ingredient. Up to now (as of 25.04.2014), not a single actually manipulated vial has been discovered in Austria.
For the majority of parallel-imported Herceptin batches affected by the recall, on the other hand, no such obvious manipulations were detected on the drug itself. However, there is also reason for concern here that the cold chain was not fully maintained. Therefore, these products must also be considered unsafe. This applies to affected Herceptin batches as well as to the affected Alimta and Remicade batches. An actual health risk or that a patient in Austria would really have been harmed cannot be proven at present. The recall is being carried out for precautionary reasons, as the safety and efficacy of the affected batches cannot be fully proven and therefore cannot be confirmed for precautionary reasons.
What measures have been taken so far?
Measures at EU level and in Austria
Who can patients contact?
Patients should contact their treating hospital or physician if they are concerned. Only the hospital can provide information about which batch of the affected products a patient actually received during their therapy or which batch(es) were used. Batches that are not affected by the recall are still considered to be fully effective and safe.
Due to the small number of affected batches, it can be assumed that the precautionary recall actions initiated will not lead to any sales restrictions or bottlenecks.
Have there already been any adverse reaction reports or reports of damage?
In the period from January 2013 to April 2014, the BASG received a total of 26 adverse event reports for Herceptin from Austria. This is well within the range of expected side effect reports of legal products and does not allow any conclusion on a connection with the use of adulterated Herceptin. Currently, there is no evidence that patients have actually been harmed by products that entered the distribution chain illegally.
Further information: BASG safety information (04/16/2014):
