Warning on diclofenac risks


Diclofenac the NSAID most commonly associated with liver injury, study finds

Caution is needed when recommending diclofenac due to an increased risk of liver injury, experts say.

A US study of 1221 Drug Induced Liver Injury Network cases found 30 cases could be attributed to eight different NSAIDs.

In more than half of these cases, diclofenac was implicated, with presentations characterised by hepatocellular injury.

Seventeen cases resulted in hospitalisation or prolongation of hospitalisation, and one patient died from complications of Stevens–Johnson syndrome because of diclofenac, said the study authors.

“Hepatocellular injury is the most common pattern seen with NSAID hepatotoxicity, and diclofenac is the most frequently implicated agent, said the multi-disciplinary research team.

“Given the number of NSAID alternatives, diclofenac should be reserved for patients who fail other NSAIDs and a high level of suspicion for hepatotoxicity should be maintained”.

Consultant clinical pharmacist Debbie Rigby said the study was an important reminder of risks associated with use of diclofenac.

Pharmacists need to assess the consumer’s risks for CVD, renal and liver adverse effects, and gastrointestinal risk before recommending the most appropriate NSAID for an individual, she said.

“Diclofenac is probably more effective than paracetamol or celecoxib for treatment of osteoarthritis of the knee. But it carries significant risks of adverse effects in some people,” she said.

“It has similar cardiovascular risk to rofecoxib, which was taken off the market many years ago for this reason. And it has the highest risk of cardiovascular events after a heart attack, even five years post-MI”.

Diclofenac has a higher risk of gastrointestinal bleeds compared to ibuprofen and COX-2 inhibitors, and oral diclofenac carries a higher risk of hepatotoxicity than other NSAIDs, with most cases occurring in the first months of use, Rigby said.

“So diclofenac is three-strikes: it increases the risk of cardiac events as much as rofecoxib or high-dose celecoxib, causes more liver toxicity than most NSAIDs, and causes more GI toxicity than celecoxib or meloxicam”.

The study was published in the journal Liver International

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