ADR that result in revision of patient information
|
| |
| The United Kingdom: EU review confirms that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac |
| |
MHRA and other EU medicines regulators have reviewed the safety of high-dose ibuprofen, following the publication of a meta-analysis of clinical trial data. This meta-analysis showed that people taking ≥2400 mg of ibuprofen per day are at a higher risk of arterial thrombotic events (heart attack, stroke) than people taking placebo. The review confirmed that this higher risk is similar to that seen with COX-2 inhibitors and diclofenac.
No increased risk of arterial thrombotic events is seen with ibuprofen at doses up to 1200 mg per day (the highest dose available over the counter) compared with not taking ibuprofen. There are limited data on the risk with ibuprofen at doses between 1200 mg and 2400 mg per day. It is uncertain whether such doses are associated with an increased cardiovascular risk compared with not taking ibuprofen.
In 2013, less than 1% of all prescriptions for ibuprofen in primary care in the UK were for 2400 mg per day or more.
The European review also considered the latest data on the possible interaction between ibuprofen and low-dose aspirin. The latest experimental data confirm previous findings that ibuprofen competitively inhibits the effect of low-dose aspirin on platelet aggregation in vivo, ex vivo and in vitro. It is uncertain if these data can be extrapolated to the clinical situation, and clinical data do not support a clinically meaningful interaction. However, the possibility that long-term, daily use of ibuprofen might reduce the cardioprotective effects of low-dose aspirin cannot be excluded.
Occasional ibuprofen use is unlikely to have a clinically meaningful effect on the benefits of low-dose aspirin.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/high-dose-ibuprofen-2400mg-day-small-increase-in-cardiovascular-risk
In Hong Kong, there are 87 registered pharmaceutical products (excluding external preparations) containing ibuprofen, and are pharmacy-only medicines. Safety alerts regarding the cardiovascular risks associated with NSAIDs has been released by various overseas regulatory authorities, and was posted on the Drug Office website since 2011. Letter to healthcare professionals to draw their attention to the alerts was issued on 30 September 2011. The matter related to cardiovascular risk of NSAID was discussed in the meeting of the Registration Committee of the Pharmacy Poisons Board (the Committee) in February 2013. The Committee concluded that NSAIDs-containing products, other than external preparations and aspirin, should include new safety warnings regarding the cardiovascular risk.
Latest news specifically on cardiovascular risk related to high dose ibuprofen has been released by the EMA, the Health Canada, and the Taiwan Food and Drug Administration, and was posted on the Drug Office website on 14 April 2015, 24 April 2015, 23 May 2015 and 24 June 2015. As previously reported, the matter will be further discussed in the Committee's meeting. The DH will remain vigilant on any safety updates of the drug by other overseas regulatory authorities.
Ends/ Saturday, June 27, 2015
Issued at HKT 13:00
|
| |
|
