Health Ministry launches review after drug recall

4.30pm

The Health Ministry is to review the safety of an entire class of pain relief drugs after multinational drug manufacturer Merck Sharpe and Dohme launched a global recall today of its arthritis drug Vioxx.

Merck announced the recall after a three-year trial into the effect of Vioxx on gastrointestinal problems was scrapped when it found the drug doubled the risk of heart attacks and strokes for people who took it for more than 18 months.

The company has offered to pay for users to seek alternative treatment as quickly as possible and says Vioxx, which is used by an estimated 15,000 New Zealanders, will be completely off pharmacy shelves by Monday.

Health Ministry drug safety agency Medsafe today announced it would review all anti-inflammatory pain relief drugs in the same "Cox-2 inhibitor" class as Vioxx.

Spokeswoman Sharon Sime said that would involve a re-examination of literature and test results and liasing with regulators in other countries to see what information they had discovered.

Currently there were four such drugs approved in New Zealand, the most popular of which was Celebrex. Other brand names include Arcoxia and Bextra.

Dr Sime said if necessary the agency could request the companies involved to recall them.

She said Medsafe was confident of its procedures despite the drug being available in New Zealand for about four years before it was discovered as unsafe.

"Medsafe is confident that our process is in line with other major countries around the world," she told NZPA.

"The balance we try to find is enabling patients and consumers to have access to new medicines that may be very beneficial in a timely manner whilst balancing the safety profile."

The alternative option would be to only approve drugs that had been available overseas for five or ten years, denying local patients access to important medical advances, she said.

Earlier, Merck New Zealand managing director Alister Brown told NZPA the new risks were detected after comparing the results of Vioxx users in the trial against those taking a placebo.

The latest trial was Merck's own and as soon as the new risk was learned the company scrapped the trial and recalled the drug.

He said other placebo-controlled studies had been done before the drug was released, but the risks did not show up.

"The difference with this study is that it had a lot more patients in it and it ran for a far longer period and it was enough to show an actual statistical difference," he told NZPA.

Mr Brown said Merck's safety procedures were sound, but if regulators asked for more detailed safety testing then Merck would comply.

The company had started its recall in the middle of the night and hoped to have Vioxx completely off pharmacy shelves by Monday.

Merck would pay for doctor visits to arrange an alternative treatment and any unused portion of the drug, he said.

The drug is worth US$2.5 ($3.77) billion in annual worldwide sales for the company.

Consumers Institute chief executive David Russell said it was disturbing that the drug had been on the market for four years before the new risks were detected.

Vioxx can also be used for treating period pain or migraine.

Arthritis New Zealand chief executive Alasdair Finnie urged Vioxx users to visit their doctor and arrange alternative treatment as soon as possible.

"People should not be afraid and suffer pain when they can discuss a variety of options with their GP," he said in a statement.

Green MP Sue Kedgley said in a statement the drug was popular because it had been heavily marketed direct to consumers.

She said the drug had been proven to be unsafe and unnecessary and showed why the Government should ban direct to consumer advertising of pharmaceuticals.

- NZPA