Published: September 2011

MARC roundup and recommendations

Prescriber Update 32(3): 27
September 2011

The Medicines Adverse Reaction Committee met on 9 June 2011 and made the following recommendations:

The risk benefit balance for bisphosphonates remains positive following a review of a possible association with oesophageal cancer. The review demonstrated there is insufficient evidence to support an association at this time; however an association cannot be discounted entirely. Further research is warranted.

The available data does not support an association between the use of angiotensin receptor blockers and cancer. This review followed the publication of a meta-analysis suggesting there was a modestly increased risk of new cancer diagnoses. The MARC agreed with the authors of the metaanalysis that additional data is required to further investigate this safety signal.

The MARC reviewed two recently published studies concerning the use of drospirenone. The Committee noted that the studies did not change previous advice issued that second generation combined oral contraceptives are associated with the lowest risk of venous thromboembolism (VTE).

The MARC noted that a case of bulging fontanelles in an infant following vaccination had been reported. Although further information is awaited on this case; the MARC noted that a potential safety signal describing benign transient bulging fontanelles has been published previously.1

Further information on all of these issues can be found in meeting minutes, available at:

  1. Freedman SB, Reed J, Burwen DR et al.2005. Transient bulging fontanelle after vaccination: case report and review of the adverse event reporting system. J Pediatr. 147(5):640-4.