The Food and Drug Administration (FDA) on Monday banned the prescription of opioid painkiller tramadol to people with hypoventilation, after the drug reportedly caused the death of a patient.
Tramadol, a prescription drug that is used to treat severe pain, is sold under 32 brand names in Taiwan, the agency said.
It can be taken orally or injected and about 100 million doses are dispensed in the nation each year, it said.
In 2017, after the FDA learned that the drug could lead to slow breathing and other respiratory problems, it mandated that manufacturers list the side effects on the package inserts, it said.
However, the agency on Monday said that it banned the prescription of the drug for patients with hypoventilation — breathing that is too shallow or slow — after it received reports that the drug had caused the death of a patient in Taiwan and breathing difficulties in two others.
Hypoventilation can lead to abnormally high amounts of carbon dioxide in the blood, the US National Institutes of Health has said.
The FDA advised people who use tramadol to talk to their doctors or contact the National Adverse Drug Reactions Reporting System if they experience breathing problems.
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