Serono, Inc. has recently become aware of a counterfeit lot of Serono's Serostim® [somatropin (rDNA origin) for injection]. The counterfeit material has been packaged to appear as drug product lot number S810-1A1. This is not a legitimate Serostim® lot number. Serono has notified the appropriate regulatory and law enforcement authorities of this matter.

The counterfeit material may have been distributed via the Internet. However, Serono is also alerting pharmacists to the counterfeit material and recommending that they examine Serostim® prior to dispensing to ensure that the package does not bear lot number S810-1A1. The counterfeit material was neither manufactured nor distributed by Serono. Therefore, it cannot be assumed that the counterfeit material is either safe or effective.

Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals. The difference is that they are deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.

A World Health Organization (WHO) survey of counterfeit medicine reports from 20 countries found that 60% of counterfeit medicine cases occurred in poor countries and 40% in industralized countries. These figures place the annual earnings from the sales of counterfeit and substandard medicines at over US$ 32 billion globally.

Besides a loss of revenues for the pharmaceuticals, these practices can also be a danger to the public health. If pharmaceuticals don't take any responsibility and action they can be held liable if any damages occur. Pretection can monitor the distribution flows of these counterfeit drugs on the Internet. This will eventually result in valuable data about the sales points and the responsible organisations. With this information pharmaceuticals can take their responsibilty and stop the distribution of these counterfeit drugs. Resulting in better revenues and brand image.