Philippines orders Novartis to pull anti-arthritis drug
Philippine health regulators on Friday ordered Swiss pharmaceutical giant Novartis to pull the painkiller Lumiracoxib from the market amid fears the drug could cause liver damage.
By Agencies |
MANILA: Philippine health regulators on Friday ordered Swiss pharmaceutical giant Novartis to pull the painkiller Lumiracoxib from the market amid fears the drug could cause liver damage.
The health department's Bureau of Food and Drugs ordered Novartis Healthcare Philippines Inc. to "immediately initiate a product recall and cease and desist from further importing, distributing, or selling Lumiracoxib (Prexige)" tablets.
A bureau advisory said it has "determined that the risks of Lumiracoxib-containing medicines are greater than their benefits," citing "reports of cases from abroad concerning potential serious liver-related side effects."
The anti-inflammatory drug is used to treat symptoms of osteoarthritis and dysmenorrhia as well as in dental and orthopaedic surgery, the bureau said.
"Patients who are using Lumiracoxib (Prexige) are advised to stop taking the drug and to immediately consult their physicians for information regarding their alternative treatments," the advisory added.
A spokeswoman for bureau director Leticia Gutierrez said: "Novartis is in the process of recalling the drug from its distribution outlets."
She added that the bureau had no data on the number of people using the drug in the country and there were no reports of any patients showing the same symptoms as those reported in other countries.
Novartis announced in November that Prexige had been suspended from sale and marketing in Britain and Germany amid fears it can cause liver damage.
Austria, Australia and Canada have taken similar steps, while Prexige has not been approved for sale in the United States.
The health department's Bureau of Food and Drugs ordered Novartis Healthcare Philippines Inc. to "immediately initiate a product recall and cease and desist from further importing, distributing, or selling Lumiracoxib (Prexige)" tablets.
A bureau advisory said it has "determined that the risks of Lumiracoxib-containing medicines are greater than their benefits," citing "reports of cases from abroad concerning potential serious liver-related side effects."
The anti-inflammatory drug is used to treat symptoms of osteoarthritis and dysmenorrhia as well as in dental and orthopaedic surgery, the bureau said.
"Patients who are using Lumiracoxib (Prexige) are advised to stop taking the drug and to immediately consult their physicians for information regarding their alternative treatments," the advisory added.
A spokeswoman for bureau director Leticia Gutierrez said: "Novartis is in the process of recalling the drug from its distribution outlets."
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She added that the bureau had no data on the number of people using the drug in the country and there were no reports of any patients showing the same symptoms as those reported in other countries.
Novartis announced in November that Prexige had been suspended from sale and marketing in Britain and Germany amid fears it can cause liver damage.
Austria, Australia and Canada have taken similar steps, while Prexige has not been approved for sale in the United States.
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