EMA launches safety review of NSAIDs

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After copious amounts of data showed that non-steroidal anti-inflammatory drugs (NSAIDs) may be linked to cardiovascular risk, the European Medicines Agency said that it will launch a review to better understand this potential risk.

Previous reports have outlined that the drugs may negatively affect gastrointestinal and cardiovascular safety, and also may lead to serious skin reactions. For example, Varas-Lorenzo et al, who conducted a systemic review of observational studies to outline stroke risk associated with individual use of NSAIDs, found that stroke was increased with the use of rofecoxib (Vioxx, Merck) and diclofenac. These drugs also increased the risk of ischemic stroke.

However, despite these negative results, the agency's Committee for Medicinal Products for Human Use (CHMP) concluded at their 2006 NSAID revieiw that the benefit-risk balance remained positive, despite findings that showed a small increased risk of thrombotic events such as MI or stroke.

The CHMP’s 2006 review concluded that:

  • Non-selective NSAIDs are important treatments for arthritis;
  • It cannot be excluded that non-selective NSAIDs may be associated with a small increase in thrombotic events, especially when used at high doses for long-term treatment; and
  • The overall benefit-risk balance for non-selective NSAIDs remains favorable when used in accordance with the product information.

“Since 2006, a number of new studies on the cardiovascular safety of NSAIDs have been published,” EMA reported. EMA said that the agency will review the results of a meta-analysis that includes data collected by the Safety of Non-Steroidal Anti-inflammatory Drug project, which was funded by the European Commission and led by investigators from Erasmus University in Rotterdam, the Netherlands.