Global Insight Perspective | |
Significance | Brazil's drug regulator Anvisa has announced a number of new restrictions on Cox-2 inhibitors, including the forced withdrawal of the 400-mg presentation of Prexige (lumiracoxib) and the 120-mg presentation of Arcoxia (etoricoxib), and stricter labelling requirements for Arcoxia, Celebra (celecoxib) and Bextra (valdecoxib). |
Implications | The new restrictions follow on from a review process that was initiated in July to re-evaluate the safety of Cox-2s, and which has led Anvisa to conclude that the risks of high-dosage Prexige and Arcoxia outweigh their benefits. |
Outlook | In the light of Anvisa's decision, Novartis has undertaken to voluntarily reimburse patients for Prexige 400 mg, but has defended the overall safety/benefit profile of its drug. Meanwhile, Merck has announced its "profound regret" and insisted that scientific evidence has demonstrated that Arcoxia 120 mg has a favourable risk-to-benefits profile. |
The products that have been suspended from the market are the 400-mg presentation of Prexige and the 120-mg presentation of Arcoxia. Consumers who have been using these drugs have been warned to ask their doctors to provide them with alternative products. According to specialists from Anvisa, the risks associated with using these drugs outweigh their benefits.
Lumiracoxib is indicated for treating osteoarthritis, acute pain, and primary dysmenorrhoea; while Etoricoxib is indicated for treating rheumatism, gout, joint pain, menstrual colic and post-operative pain. According to Anvisa, patients using Prexige have experienced liver problems, such as drug-induced hepatitis; while Arcoxia has been associated with cardiovascular problems, such as hypertension.
New Restrictions Imposed on Low-Dose Arcoxia, Celebra and Bextra
In addition to the product suspensions, new stricter labelling requirements have been imposed on the following Cox-2 inhibitors:
- The 60-mg and 90-mg presentations of Arcoxia will be required to include new safety warnings relating to its potential impact on high blood pressure and cardiovascular disease.
- Pfizer's (U.S.) Celebra (celecoxib) will have to carry new warnings in relation to the time of treatment and its use during pregnancy or breast-feeding.
- Pfizer's Bextra (valdecoxib) will be restricted to use in hospitals.
Henceforth, all of the above anti-inflammatories can only be sold if the pharmacy retains the prescription. Anvisa's new stricter controls for Cox-2s will be published in today's Diário Oficial.
Outlook and Implications
Anvisa's new restrictions follow on from a review process that began in July to re-evaluate the safety of Cox-2 inhibitors (see Brazil: 9 September 2008: Anvisa to Go Stricter on Use of Cox-2 Inhibitors Drugs). During the same month, the 100-mg presentation of Prexige was withdrawn and its 400-mg presentation was suspended for a period of 90 days (see Brazil: 23 July 2008: Anvisa Bans Sales of 100-mg Prexige in Brazil). Previously, usage of the 400-mg presentation of Prexige had been restricted to hospitals.
According to the Folha de São Paulo, Novartis has announced that it has already begun voluntarily reimbursing patients for the cost of its recalled product, while at the same time noting that Prexige "represents a safe and effective therapeutic option for the treatment of acute pain". Meanwhile, the newspaper reports that Merck has announced that it "profoundly regrets" the decision to withdraw Arcoxia 120 mg and that it has claimed that Anvisa's decision "does not reflect the scientific evidence for Arcoxia, based on studies which prove the favourable risk/benefit profile of the drug". However, last year, the U.S. FDA refused to approve Arcoxia
According to Anvisa, 1.3 million packs of anti-inflammatories have been sold in pharmacies and drugstores this year.