Falsification suspicion of parallel-imported "ALIMTA 500 mg powder for the preparation of a concentrate for infusion solution".
Situation in Austria
The Federal Office for Safety in Health Care (BASG) has received information that several packages of the drug "ALIMTA 500 mg Powder for the Preparation of a Concentrate for the Preparation of an Infusion Solution", for which there is urgent suspicion of counterfeiting, have entered the legal distribution chain through parallel trade. According to the current state of affairs, the products in question are original, but their shelf life has been illegally extended by one year by unknown third parties. For the illegal marketing of the goods, new labels were produced by third parties and packaging materials were manipulated, which constitutes counterfeit packaging. The source of the counterfeits is currently unknown, but is already the subject of investigations by law enforcement agencies in other EU member states. Analyses by the original manufacturer's drug control laboratory showed that the contents of the vials had not been tampered with. The active ingredient could be identified analytically.
Based on the investigations, it is suspected that already expired vials were relabeled by criminal individuals or criminal organizations and then illegally placed on the European market with tampered packaging. Out of 32 packs of the affected batch circulating in Austria, 5 packs were stopped or quarantined before use. By contacting all pharmacies supplied, it can be ruled out that packages of the affected batch are still stored in these pharmacies, the hospitals they supply, or even at individual patients' homes.
The active ingredient of ALIMTA, pemetrexed, is basically an active pharmaceutical ingredient that can be described as stable, so that - to a limited extent - e.g. in the case of one-year expiry or improper storage, from today's point of view there are no indications of an acute health hazard. Nevertheless, this situation is not compatible with safe and effective drug therapy on the basis of the precautionary principle, which is why the affected batch (see below) was recalled as soon as the first suspicious facts became known.
In Austria, the following batch of the drug is affected:
| Name | Registration number | Batch number |
|---|---|---|
| ALIMTA 500 mg Powder for the Preparation of a Concentrate for Solution for Infusion | EU/1/04/290/001 | C586047F |
Marketing authorization holder: Eli Lilly Nederland B.V.
Parallel distributor concerned: Haemato Pharm GmbH
At present, BASG has not received any reports of adverse drug reactions from Austria that are relevant to this case.
Information on the drug
ALIMTA is indicated for certain thoracic and lung cancers.
Indications according to the SmPC: Malignant pleural mesothelioma: ALIMTA in combination with cisplatin is indicated for the treatment of chemonaive patients with unresectable malignant pleural mesothelioma. Non-Small Cell Lung Cancer: ALIMTA in combination with cisplatin is indicated for first-line therapy of patients with locally advanced or metastatic non-small cell lung cancer except with predominant squamous histology. ALIMTA in monotherapy is indicated for maintenance therapy of locally advanced or metastatic non-small cell lung cancer except with predominant squamous histology in patients whose disease has not immediately progressed following platinum-based chemotherapy. ALIMTA in monotherapy is indicated for second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer except in cases of predominant squamous histology.
BASG recommendations for physicians, pharmacists and pharmacies
The drug in question requires a prescription and is predominantly used in the inpatient setting. It is recommended to evaluate the efficacy of the treatments carried out with ALIMTA 500 mg of this batch and to immediately bring any findings to the attention of the BASG via the vigilance system.
Further information:
ALIMTA Specialty Information (EMA)
https://www.ema.europa.eu/documents/product-information/alimta-epar-product-information_de.pdf
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: +43 505 55-36004
E-mail:
Queries (for media):
Communications Management, Tel.: +43 505 55-25000
E-mail:
