Drug safety update


Cetuximab: importance of establishing wild type RAS (KRASand NRAS) status before treatment of metastatic colorectal cancer

In the treatment of metastatic colorectal cancer, inferior overall survival, progression-free survival, and objective response rates have been shown in people with RAS mutations (at exons 2, 3, and 4 ofKRAS and NRAS) who received cetuximab in combination with FOLFOX4 (oxaliplatin-containing) chemotherapy versus FOLFOX4 alone. Cetuximab is now indicated for the treatment of people with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in combination with irinotecan or oxaliplatin based chemotherapy or as a single agent.


Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small—consider risk factors and remain vigilant for signs and symptoms

A review of the latest evidence on the risk of thromboembolism in association with combined hormonal contraceptives (CHCs) has concluded that:

  • the risk of blood clots with all low-dose CHCs is small

  • there is good evidence that the risk of venous thromboembolism (VTE) may vary between products, depending on the progestogen

  • CHCs that contain levonorgestrel, norethisterone, or norgestimate have the lowest risk of VTE

  • the benefits of any CHC far outweigh the risk of serious side effects

  • prescribers and women should be aware of the major risk factors for thromboembolism, and of the key signs and symptoms.

Posted on the UK MHRA website on 14 February 2014