Vectibix Side Effects Linked to Ulcerative Keratitis, Eye Problems: MHRA

U.K. health officials indicate that a class of cancer drugs, which includes Vectibix and Erbitux, may be linked to a risk of serious eye problems and vision loss. 

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a drug safety update this week on a class of drugs known as epidermal growth factor receptor (EGFR) inhibitors.

The MHRA indicates that it has received reports of cornea inflammation, known as keratitis. In some cases, ulcers develop in the cornea, a condition known as ulcerative keratitis. These conditions can lead to reduced vision, extreme pain and blindness.

According to the MHRA, Amgen, the makers of Vectibix, first sent out a letter warning healthcare professionals (PDF) of a possible link a year ago. The letter warned that serious cases of keratitis and ulcerative keratitis had been reported and indicated that any patients showing signs of ulcerative keratitis on Vectibix should be taken off the drug.

The MHRA has decided to update the labels on all EGFR inhibitors sold in the U.K., and provided the following notifications to healthcare professionals this week:

• Ulcerative keratitis is an ophthalmological emergency
• Patients undergoing treatment with EGFR inhibitors who present with acute or worsening signs and symptoms suggestive of keratitis such as: eye inflammation; increased lacrimation; light sensitivity; blurred vision; eye pain and/or red eye should be referred promptly to an ophthalmology specialist
• If a diagnosis of ulcerative keratitis is confirmed, treatment with the EGFR inhibitor should be interrupted or discontinued.

Vectibix (panitumumab) was approved in the United States in 2006 by the FDA for the treatment of colon cancer. Erbitux (cetuximab) was introduced by Eli Lilly & Co.’s ImClone in 2004.