Catalent fined after contact with olanzapine leads to dermatitis

By Nick Taylor

- Last updated on 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.

Related news

Related products

show more

Reliability, scale, and security of supply

Reliability, scale, and security of supply

Content provided by Univar Solutions USA | 28-Aug-2024 | Product Brochure

Univar Solutions Pharmaceutical Ingredients is proud to offer one of the most expansive portfolios of 15,000+ products, including high-purity solvents,...

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Related suppliers

Follow us

Products

View more

Webinars