Arthritis drug undergoes safety check

Dubai: The future of an arthritis drug in the UAE, touted as successor to withdrawn heart-dangerous painkiller Vioxx, is uncertain after the US drug authority rejected its manufacturer's approval application for similar reasons.

The Food and Drug Administration decided on Friday not to approve Arcoxia, a Cox-2 inhibitor to treat inflammation of the joints, due to increased cardiovascular risks, the same reasons for the voluntary withdrawal of Vioxx in 2004.

The drug, manufactured by Merck, Sharpe and Dohme (MSD), has been available for four years in the UAE, where most pharmacists have been selling the general prescription drug over the counter.

Dr Fatima Ali Abdullah, Deputy Director of drug control department at the Ministry of Health, told Gulf News that the ministry was reviewing the safety data on the drug.

"We are aware of the concerns. We are keeping in contact with the company and we have our eyes open, following up and monitoring the safety of the product," she said.

Gentle on stomach

Several studies have linked Arcoxia to increased blood pressure, tissue swelling that can lead to heart problems and congestive heart failure. Dr Fatima also said that the ministry would announce their decision whether to withdraw, continue approval or restrict the sale of the drug within two days.

MSD issued a statement, quoting the company's research laboratories president, Dr Peter S. Kim, who vouched for the safety of the product, which selling point was its gentleness on the stomach compared to other anti-inflammatory drugs.

"There is more long-term safety data from controlled clinical trials, in terms of patient-years on treatment, for Arcoxia than for any other non-steroidal anti-inflammatory drug (NSAID), including traditional NSAIDs and Cox-2 selective inhibitors," he said.

The Emirates Arthritis Foundation has also come out in defence of the drug, saying that complete withdrawal of Arcoxia would be 'a loss' for younger patients who are at risk of gastrointestinal bleeding.

Dr Humeira Badsha, specialist rheumatologist and spokesperson for the Emirates Arthritis Foundation, said health authorities instead should make sure that the drug was not as readily available to the public as it was now.

Although the drug is classified as a general prescription drug, which means any licensed physician can prescribe it, pharmacists tend to interpret drugs under the category as over-the-counter drugs.

"The problem with Vioxx was the overuse of it. Rather than withdraw Arcoxia, health authorities should instead restrict it. Patients should not be allowed to buy it without a prescription," she said.

"The Ministry of Health should look into the practice of selling these drugs without a prescription," she added. MSD also advises patients to consult a physician before taking the drug, stating that it should not be sold over the counter.

Medicine is available over the counter

The US Food and Drug Administraion has decided not to approve Arcoxia, a Cox-2 inhibitor drug manufactured by Merck, Sharpe and Dohme (MSD), due to increased cardiovascular risks.

Several studies have linked Arcoxia to increased blood pressure, tissue swelling that can lead to heart problems and congestive heart failure.

The drug has been available for four years in the UAE. Most pharmacists here have been selling the general prescription drug over the counter.