Please login to the form below

Not currently logged in
Email:
Password:

Amgen recalls Epogen and Procrit vials

Certain lots of anaemia drugs are being voluntarily recalled by Amgen and J&J due to thin glass flakes in the product

Certain lots of Epogen and Procrit (epoetin alfa) vials, indicated for the treatment of anaemia related to HIV therapy, chronic renal failure and chemotherapy are being voluntarily recalled by Amgen and Johnson & Johnson (J&J) from specialist distributors, wholesalers, pharmacies and healthcare providers as a precaution.

The decision is based on news that the vials may contain extremely thin glass flakes (lamellae) resulting from the interaction of the formulation with glass vials over the shelf life of the product.

Although Amgen said the flakes were barely visible in most cases, and that they have fielded no complaints or reports of adverse events that could be directly tied to them, they advised patients experiencing problems to contact their doctor.

Evaluations conducted by the company indicate that the potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events, and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity.

According to a report on Bloomberg Businessweek on September 24, Epogen is Amgen's fourth-best-selling product, with $2.57bn in sales last year, while Procrit brought in $2.25bn for J&J, which licenses the drug from Amgen.

27th September 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
JPA Health Communications

JPA Health is an award-winning public relations, marketing and advocacy firm known for sharing our clients’ commitment to making people...

Latest intelligence

PRO
Integrating patient reported outcomes into clinical trials
How capturing the patient voice is unlocking medicines’ commercial potential...
Theodora Harold
A snapshot of Crescendo Biologics
PME talks to CEO Theodora Harold...
eyeforpharma Marketing and Customer Innovation Europe
By Richard Springham...

Infographics