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| Version 1 | Version 2 |
|---|---|
| Arthritis drug licence suspended | Arthritis drug licence suspended |
| (2 days later) | |
| A drug for osteoarthritis has been withdrawn from sale in the UK amid concerns it may cause liver damage. | |
| The Medicines and Healthcare products Regulatory Agency (MHRA) suspended the licence for Prexige, and advised doctors not to prescribe it. | The Medicines and Healthcare products Regulatory Agency (MHRA) suspended the licence for Prexige, and advised doctors not to prescribe it. |
| The Commission on Human Medicines found an increase in the number of serious liver reactions among patients taking a 100mg dose of the drug. | The Commission on Human Medicines found an increase in the number of serious liver reactions among patients taking a 100mg dose of the drug. |
| Prexige (lumiracoxib) has been available in the UK since late 2005. | Prexige (lumiracoxib) has been available in the UK since late 2005. |
| Patients taking Prexige should make an appointment to see their doctor at the next convenient opportunity Dr June RaineMHRA | Patients taking Prexige should make an appointment to see their doctor at the next convenient opportunity Dr June RaineMHRA |
| Patients who are taking Prexige - made by Novartis - and who feel unwell are advised to stop taking it immediately. | Patients who are taking Prexige - made by Novartis - and who feel unwell are advised to stop taking it immediately. |
| Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA, said: "Patients taking Prexige should make an appointment to see their doctor at the next convenient opportunity." | Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA, said: "Patients taking Prexige should make an appointment to see their doctor at the next convenient opportunity." |
| The MHRA move is the latest in a series of setbacks to hit the class of drugs to which Prexige belongs, the Cox-2 inhibitors. | The MHRA move is the latest in a series of setbacks to hit the class of drugs to which Prexige belongs, the Cox-2 inhibitors. |
| Another drug in the class, Vioxx, was withdrawn after being linked to an increased risk of heart attack and stroke. | Another drug in the class, Vioxx, was withdrawn after being linked to an increased risk of heart attack and stroke. |
| Its makers, Merck, last week agreed to pay out £2.4bn to settle claims for injuries allegedly caused by the drug. | Its makers, Merck, last week agreed to pay out £2.4bn to settle claims for injuries allegedly caused by the drug. |
| And the European Medicines Agency has said doctors should also be "cautious" about giving any Cox-2 inhibitor to patients who have risk factors for heart disease. | And the European Medicines Agency has said doctors should also be "cautious" about giving any Cox-2 inhibitor to patients who have risk factors for heart disease. |
| Thousands of prescriptions | Thousands of prescriptions |
| Around 5,000 patients in the UK have been prescribed Prexige, which helps ease the pain of osteoarthritis, particularly in the knee. It was already restricted for use in patients with liver problems. | Around 5,000 patients in the UK have been prescribed Prexige, which helps ease the pain of osteoarthritis, particularly in the knee. It was already restricted for use in patients with liver problems. |
| In Britain, there have been 23 reports of suspected adverse reactions since March 2006 - three of which were related to liver problems. | In Britain, there have been 23 reports of suspected adverse reactions since March 2006 - three of which were related to liver problems. |
| None were said to have been severe, and the MHRA stressed that there was no proof they were caused by the drug. | None were said to have been severe, and the MHRA stressed that there was no proof they were caused by the drug. |
| A Europe-wide review of the risks and benefits of treatment with Prexige will now be conducted and further advice will be issued when the review has concluded. | A Europe-wide review of the risks and benefits of treatment with Prexige will now be conducted and further advice will be issued when the review has concluded. |
| A spokeswoman for the Arthritis Research Campaign said the withdrawal of Prexige was a major blow for osteoarthritis sufferers. | A spokeswoman for the Arthritis Research Campaign said the withdrawal of Prexige was a major blow for osteoarthritis sufferers. |
| She said: "This means there is even less choice available for people with osteoarthritis who are already struggling to find effective pain relief without unacceptable side effects." | She said: "This means there is even less choice available for people with osteoarthritis who are already struggling to find effective pain relief without unacceptable side effects." |
| In a statement, Novartis said it continued to believe Prexige was an important treatment option with a positive benefit/risk ratio when used in appropriate patients. | In a statement, Novartis said it continued to believe Prexige was an important treatment option with a positive benefit/risk ratio when used in appropriate patients. |