Catalent fined after contact with olanzapine leads to dermatitis

22-Dec-2010 - Last updated on 22-Dec-2010 at 10:48 GMT

Catalent has been fined after contact with olanzapine led to employees developing dermatitis, an incident the company “deeply regrets”.

The UK Health and Safety Executive (HSE) prosecuted Catalent after 10 employees at its Swindon plant developed allergic contact dermatitis, an irreversible skin condition. Catalent pleaded guilty and was ordered to pay a £50,000 ($77,000) fine and £50,000 in costs.

Joanna Knight, a HSE inspector, said Catalent “failed to address the inadequacies not only in its systems for working with hazardous substances, but also in its systems for health surveillance and keeping health records”.

The company says it has now addressed these issues. “Catalent has fully cooperated with the HSE and has implemented all recommended engineering and procedural improvements to safeguard our employees’ health”, a company spokesperson told Outsourcing-Pharma.

“These actions include significant changes in oversight and monitoring of employee health and safety. The facility is now compliant with all applicable health and safety regulations.”

Olanzapine exposure

HSE claimed skin conditions were developed after exposure to olanzapine, the active in Eli Lilly's Zyprexa. Catalent identified olanzapine as a potential cause of dermatitis, said HSE, but failed to initiate an immediate review of its risk assessment as required by law.

Cases of allergic contact dermatitis were confirmed in October and December 2007. Catalent launched a thorough review in February 2008, Swindon Magistrates were told. By this time the HSE had also visited the company.

During the HSE investigation a further eight employees were confirmed to have allergic contact dermatitis from exposure to olanzapine. The cases of allergic contact dermatitis “could have been completely avoided had Catalent taken the time to review its risk assessment”, said Knight.

Catalent “deeply regrets” the incident and any duress it may have caused to employees and their families. The company is "working closely with the affected employees to ensure the provision of proper medical care and the appropriate management of their conditions”, said a spokesperson.