Institute warns against counterfeit cancer drugs

Authority warns against counterfeit medicines

04/17/2014

In Europe, stolen or counterfeit Herceptin was put on the market. The vials of the cancer medicine containing the active substance trastuzumab were probably stolen in Italy. Alimta and Humatrope have also been potentially manipulated.

Health professionals called to vigilance
As the European Medicines Agency (EMA) announced, counterfeit Herceptin has been traded in Europe. The EMA is calling for health care professionals to be vigilant. Apparently, in Italy vials of the cancer drug Herceptin (active ingredient: trastuzumab) were stolen, manipulated and put back on the market with false certificates. Even from hospitals, the drugs had been stolen. The case will be investigated by the authorities of the Member States. In Italy you not only go after the theft, but also check if other medicines are affected. As reported by the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn on Thursday, ampoules containing the drugs Alimta and Humatrope may also have been manipulated.

No patients have been harmed yet
As the EMA explained, in hospitals or medical practices, no affected Herceptin vials have been found so far. In addition, there were no reports that patients were harmed in connection with the counterfeit drug. However, healthcare professionals should be attentive and closely examine Herceptin vials. This also applies to parallel importers.

Signs of a forgery
Especially doctors and pharmacists should therefore pay attention to certain signs that point to a forgery. For example, for most of the vials concerned, the lot number and expiration date are different from the pack. In addition, some vials show fluid, although Herceptin is a white to yellow powder that needs to be dissolved. Even depressed lids or tampering with the closures - rubber stoppers or crimp caps - can be a sign of tampering. The counterfeit vials also carry the label Italian Herceptin® 150 mg.

Recall of the affected batches
If suspicious bottles are detected, this should be reported to the national authorities. As the EMA said, these medicines should not be used. The lot numbers already known to be affected are: H4311B07, H4329B01, H4284B04, H4319B02, H4324B03, H4196B01, H4271B01, H4301B09 and H4303B01. Although only a few of these vials are likely to be actually affected, Roche, the authorization holder, nevertheless, as a precaution, recalls all those who might be falsified.

No delivery bottlenecks expected
Although the investigations are still in their infancy, the EMA does not expect supply bottlenecks to occur. If affected patients are concerned, they should talk to their doctor and get the authenticity of their medicine confirmed. Herceptin is used predominantly in hospitals and in medical practices with oncological or gynecological focus on the treatment of breast cancer and metastatic gastric cancer. Trade in counterfeit medicines has long been a global problem. According to the Customs Criminal Office, last June 9.8 million plagiarisms were confiscated in around 100 countries in a global raid led by Interpol. But how many such fakes are actually produced remains unknown.

Possibly two more drugs manipulated
As reported by the German Federal Institute for Drugs and Medical Devices (BfArM) in Bonn on Thursday, ampoules containing the drugs Alimta and Humatrope may also have been manipulated. Alimta, with its active ingredient pemetrexed, is used in hospitals and oncology clinics to treat two lung cancers. Humatrope contains the active ingredient somatropin, which is used among other things for the treatment of growth hormone disorders. According to the BfArm, Alimta is concerned with batches C134092E, C021161E and C160908C and with Humatrope batch C165977C. So far, however, it is unknown whether and how these batches were manipulated and traded. (Sb)