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Is there evidence linking rosuvastatin and mouth ulcers?

Associated tags: adverse events, Cardiovascular disease, mouth ulcers, Oral health, rosuvastatin, statins

Question DetailsView Comments (0)

ANSWER

provided by Trip / NLH

Moderate

Appraisal

Moderate

Confidence

Poor

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Answer Rating key

	search		strong
	appraisal		weak
	confidence		moderate

Question answered:29/01/08 Warning! this question is over two years old.

The SPC for Crestor [1] doesn’t list mouth ulcers as an adverse event. Similarly a search of medline found no records. Two American sites – drugs.com [2] and RxList [3] both have entries for rosuvastatin and neither mentions mouth ulcers, although the former mentions periodontal abscess as a potential adverse reaction.

We did find a document on the MHRA website, “Adverse drug reactions online information tracking” for rosuvastatin [4]. This appears to indicate that there have been 4 reports of mouth ulceration associated with rosuvastatin. However, there is no key with the document so we may have mis-interpreted this!

References

1) http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=11976
2) http://www.drugs.com/ppa/rosuvastatin-calcium.html
3) http://www.rxlist.com/cgi/generic/crestor_ad.htm
4) http://www.mhra.gov.uk/home/groups/public/documents/sentineldocuments/dap_1152181553135.pdf

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