Shares in Genzyme Corp have taken a bashing after regulators in the USA warned healthcare professionals about possible contamination of five of the company’s products.

The US Food and Drug Administration issued a statement concerning the potential for foreign particle contamination in all lots of Genzyme’s Cerezyme (imiglucerase) for Gaucher disease, Fabrazyme (agalsidase beta) for Fabry disease, Myozyme (alglucosidase alpha) for Pompe disease, Aldurazyme (laronidase) for mucopolysaccharidosis type I and Thyrogen (thyrotropin alpha) for thyroid cancer. The agency notes that the particles, containing stainless steel fragments, non-latex rubber from the vial stopper, and “fibre-like material from the manufacturing process” could potentially cause serious adverse events.

However the FDA noted that the foreign particles are believed to be found in less than 1% of products based on lots assessed to date. It also noted that no related adverse events have been reported yet and the affected products are not being withdrawn due to “the lack of FDA-approved therapeutic alternatives”.

The contaminated drugs were manufactured at Genzyme’s Allston Landing, Boston facility which was temporarily shut down in June after a bioreactor was contaminated with a virus. This affected production of Cerezyme and Fabrazyme.

Genzyme said that “the safety profile of these products remains unchanged” and a review of the global safety database has not identified any safety concerns. It does however acknowledge that “a theoretical safety risk remains should a particle enter the bloodstream”.

The announcement upset investors, however, and Genzyme’s shares fell 7.3% to $49.28.

FDA warns Shire over Fosrenol promotion
News of Genzyme’s problems led to a rise in shares of Shire, which was allowed by the FDA to distribute its investigational Gaucher disease drug velaglucerase alfa earlier this year after the manufacturing problems for Cerezyme emerged. However the FDA has warned the company about promotional materials it uses for kidney disease drug Fosrenol (lanthanum).

The agency says that a company brochure for Fosrenol omits risk information and makes unsubstantiated claims that the drug works better than rival treatments. The FDA has issued a letter to Shire noting that it has expressed misgivings to the company before and “we are concerned that you are continuing to promote Fosrenol in a similarly violative manner”.

The regulator wants Shire to immediately stop dissemination of the brochure and to explain how it will provide truthful information to people who may have seen the original. The company is reviewing the letter and has until November 20 to respond.

...and criticises Eisai over Dacogen
The FDA also sent a warning letter to Eisai about a promotional card for Dacogen (decitabine) for the treatment of myelodysplastic syndromesagency. The agency says the card omits and minimises risk information, and is misleading.