TAIPEI (CNA) — Taiwan on Monday imposed a ban on the use of the pain medication tramadol for patients with a certain respiratory problem, after it was reported that the drug had caused the death of one patient and breathing problems in at least two others.
Tramadol, a prescription drug that is used to treat severe pain, is sold under 32 brand names in Taiwan, according to the Food and Drug Administration (FDA). It can be taken orally or injected, and around 100 million doses are dispensed in the country each year, the FDA said.
In 2017, after the FDA learned that the drug could lead to slow breathing and other respiratory problems, it mandated that manufacturers include those side effects on the package inserts, it said Monday.
The FDA said, however, that it is now prohibiting 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, according to the United States’ National Institutes of Health.
The FDA also advised patients who are taking tramadol to report to their doctors and the National Adverse Drug Reactions Reporting System if they experience any breathing problems.