Recall of Jakavi 15 mg tablets due to suspected counterfeiting

Safety warnings | Medicines | 25/10/2018

Situation in Austria

The Federal Office for Safety in Health Care has received information that several packages of the drug Jakavi 15 mg tablets, for which there is an urgent suspicion of counterfeiting, have entered the legal distribution chain as a result of parallel distribution. As things stand today, these are exclusively counterfeit packaging. This means that both the blister (primary packaging) and the folding box (secondary packaging) were not produced by the original manufacturer and were not placed on the market by the original manufacturer. The source of the counterfeits is currently unknown, but is already the subject of investigation by law enforcement authorities. Initial analyses carried out by the authority's drug control laboratory (OMCL) have shown that the tablets in question are probably authentic original tablets. The active ingredient has already been identified analytically as being present in relevant quantities.

There is thus the suspicion that already expired original tablets were repackaged by individual fraudsters or criminal organizations and then illegally marketed at the European level. Of a medium double-digit number of packages that were in circulation in Austria, about half were already stopped or quarantined before delivery and dispensing. However, it cannot be ruled out that some packages of these two batches, which were traded throughout Europe, have already been dispensed to individual patients.

The active ingredient in Jakavi, ruxolitinib, is generally considered stable, so that - to a limited extent - there are no indications at present of an acute health hazard in the event of expiry or improper storage. Nevertheless, this situation is not compatible with safe and effective drug therapy on the basis of the precautionary principle, which is why a complete recall of the two affected batches (see below) has been initiated. More precise detailed parameters (full analysis) of the incriminated batches regarding the identity and content of the tablets are now being determined in elaborate detailed investigations. These analytical procedures are already in full swing.

In Austria, the following batches of the drug are affected:

Name	Registration number	Batch numbers
Jakavi 15 mg Tablets	EU/1/12/773/002,007-009	SM018, SAD42

Marketing authorization holder: Novartis Europharm Limited

Affected parallel distributors: Haemato Pharm GmbH and Abacus Medicine A/S

At the present time, BASG has not received any reports of adverse drug reactions from Austria that are relevant to this case.

Information on the drug

Jakavi is indicated for certain blood cancers of the bone marrow.

Indications according to the expert information:

Myelofibrosis (MF): Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adults with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythaemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.

Polycythaemia vera (PV): Jakavi is indicated for the treatment of adults with polycythaemia vera who are resistant or intolerant to hydroxycarbamide.

BASG recommendations for patients

The recall is being issued as a purely precautionary measure. Nevertheless, for precautionary reasons, it is recommended that affected packs be exchanged for a new, unaffected pack as soon as possible in consultation with your doctor or pharmacist. The affected medicine is available only on prescription, so that in any case a contact to the attending physician should be established. Do not stop treatment with Jakavi without consulting your doctor. If you have any further questions or feel unsure, please contact your doctor or pharmacist. There is no acute patient risk.

Further information: Jakavi (EMA) SmPC https://www.ema.europa.eu/documents/product-information/jakavi-epar-product-information_de.pdf