The government has received reports of adverse drug reactions, including pneumonia, ALT (alanine aminotransferase) and AST (aspartate aminotransferase) elevations, in 746 patients who took tenofovir disoproxil-based drugs to treat hepatitis B and HIV, in postmarketing surveillance (PMS).
Through PMS, the regulators monitor the safety of a new drug after the market release.
The Ministry of Food and Drug Safety said it would collect the related drugmakers’ opinions by Dec. 18 and reflect the PMS results on the drug approval conditions.
According to the six-year PMS for a re-evaluation of tenofovir disoproxil-based drugs, the medicines had 11.66 percent incidence rate of adverse events, or 87 patients out of 746 reporting 225 cases of adverse drug reactions, regardless of causal relationship. Among them, four rare cases (0.1-1 percent) occurred as serious adverse drug reactions that could not rule out a causal relationship. The four are pneumonia, ALT and AST elevations, and osteoporosis.
Unpredicted adverse reactions that could not rule out a causal relationship included 22 reports (0.1-1 percent), such as indigestion, gastroesophageal reflux, uneasiness in the abdomen, chronic gastritis, uneasiness in the solar plexus, dry mouth, pneumonia, weight loss, urine reduction, hair loss, rash, sleep disorder, and osteoporosis.
Severe adverse reactions regardless of a causal relationship amounted to 50 cases, including indigestion, constipation, gastroesophageal reflux, vomit, hydrops abdominis, abdominal inflation, urinary tract infection, shingles, asthenia, and arthralgia.
Thirty-two drugs manufactured by 30 drugmakers will face a change in approval conditions. They include Gilead’s Viread and Stribild, Janssen Korea’s Complera, and incrementally modified medicines and generic drugs referencing Viread for which local drugmakers had received the license.
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