ARTHRITIS drug VIOXX is being been removed from pharmacy shelves after US manufacturers Merck & Co issued a worldwide withdrawal of the drug on Thursday amid fears of increased heart disease and stroke amongst patients.
Celia Stelikou, a representative of the Cypriot importers MS Jacovides, yesterday told the Cyprus Mail that the notice from Merck had come out on Thursday afternoon.
“All the pharmacies have been informed and every patient that has the medication can take it back to the pharmacies and receive their money back,” said Stelikou.
VIOXX has been on the Cyprus market since 1999, but Stelikou said the company had no figures available about the number of users.
”We don’t have the actual numbers because it’s for chronic and acute cases, but it would be many thousands,” she said.
However, she said the company had no reports of people experiencing problems with the drug in Cyprus because people were usually only prescribed it for periods of less than six months.
The risks identified relate to the continuous treatment of patients with VIOXX over a period of 18 months or more.
Stelikou was unable to say why the company had not just warned doctors and patients that there was a risk to some users after 18 months of continuous treatment.
“That is a good question but it is important to highlight that the company is withdrawing it voluntarily,” she said.
“They could have continued to market the product with some changes to the labelling but instead of that the company thought it would be more ethical and responsible as a global company to withdraw it from the market as there are other alternatives available.”
Merck’s announcement on Thursday said the company’s decision, effective immediately, was based on new, three-year data from prospective, randomised, placebo-controlled clinical trials.
“In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX compared to those taking placebo,” the announcement said.
“We are taking this action because we believe it best serves the interests of patients,” said Raymond V. Gilmartin, chairman, president and chief executive officer of Merck.
“Although we believe it would have been possible to continue to market VIOXX with labelling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take.”
VIOXX was launched in the US in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion.
