Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
- Medicines and Healthcare products Regulatory Agency
- 22 May 2012
- Therapeutic area:
Patients who present with acute or worsening signs and symptoms of keratitis should be referred promptly to an ophthalmology specialist.
Article date: May 2012
EGFR promotes cell growth in normal epithelial tissues including the skin and is expressed on a variety of tumour cells. The EGFR inhibitors, cetuximab (Erbitux), erlotinib (Tarceva▼), gefitinib (Iressa▼) and panitumumab (Vectibix▼), are used to treat EGFR-expressing tumours.
Reports of keratitis and ulcerative keratitis
The cornea is covered with a layer of epithelium which may be damaged by treatment with EGFR inhibitors. Patients with a history of keratitis, ulcerative keratitis or severe dry eye may be particularly at risk. Serious cases of keratitis and ulcerative keratitis (corneal ulceration) have been reported with varying frequency following treatment with an EGFR inhibitor. In rare cases, this has led to corneal perforation and blindness. Ulcerative keratitis must therefore be regarded as an ophthalmological emergency.
This issue was first identified with panitumumab (Vectibix) and a letter sent to healthcare professionals in May 2011. The risk of keratitis and severe keratitis is now considered a class effect for all EGFR inhibitors, and information for all products in this class has been updated with warnings on this risk.
Advice for healthcare professionals:
- ulcerative keratitis is an opthalmological 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
Patients with a history of keratitis, ulcerative keratitis or severe dry eye may be particularly at risk of ocular damage with EGFR inhibitors.
BNF section 8.1 Cytotoxic drugs
Updated product information on keratitis and ulcerative keratitis can be found in individual Summaries of Product Characteristics (see the electronic Medicines Compendium
Article citation: Drug Safety Update May 2012, vol 5 issue 10: A4
Published: 22 May 2012
Therapeutic area: Cancer