Type-2 antidiabetic treatment Linagliptin has had a 7.69 percent incidence of abnormal events in the past six years in Korea, the government said Monday. The data came from the regulator’s post-marketing surveillance on 3,119 patients.

According to the Ministry of Food and Drug Safety’s PMS, 240 out of the 3,119 patients experienced 313 cases of adverse drug events.

Among the 313 cases, 63 serious adverse cases (1.57 percent) without a causal relation appeared in 49 patients.

They mainly complained of pneumonia, hyperglycemia, dyspnea (less than 0.1 to 5 percent), constipation, gastroenteritis, shingles, cystitis, loss of appetite, dehydration and facial edema (less than 0.1 percent).

Three patients suffered six cases of serious adverse events that could not exclude the causal relationship including pain in upper abdomen, pneumonia, hyperglycemia, loss of appetite, fatigue, and skin lesion.

The incidence rate of unexpected adverse events without causality was 6.64 percent. Two-hundred-and-seven patients had 270 such cases including nausea, diarrhea, gastroesophageal reflux disease, upper respiratory tract infection, gastroenteritis, pneumonia, herpes zoster, cystitis, hyperglycemia, dizziness, insomnia, and hypertension (less than 0.1-5 percent).

The incidence of unexpected adverse drug reactions that could not rule out causal relations was 1.19 percent and 48 cases including nausea, upper abdominal pain, dizziness, and itching (less than 0.1-5 percent) appeared in 37 patients.

There are seven linagliptin drugs in Korea. They are Boehringer Ingelheim Korea’s Trajenta, Glyxambi Tab. (ingredient: linagliptin/empagliflozin), Kukje Pharm’s Tradi-M Tab., Aju Pharm’s Glijenta Tab., Alvogen Korea’s Linatigen Tab., Ahngook Pharm’s Ahngook Linagliptin Tab., and Hanwha Pharma’s Traglin Tab.

Combination drugs of linagliptin and metformin such as Trajenta Duo, Linaglo Duo, and Ahngook Lina Duo had higher incidence rates of abnormal drug reactions.

According to the five-year PMS on 709 patients, the incidence of adverse events without causal relationship was 11.99 percent. Ninety-eight cases occurred in 85 out of 709 patients.

Combo drugs had a 9.17 percent incidence of serious adverse events without a causal relationship. The abnormal reactions included upper respiratory tract infection, indigestion, anal bleeding, stomatitis, fever, facial edema, angina, vocal disorders, and myelodysplastic syndrome.

The incidence of serious adverse drug reactions that could not rule out causality was 0.99 percent including gingivitis, dyspepsia, abdominal pain, stomatitis, increased serum creatinine, facial edema, and myelodysplastic syndrome.

The MFDS said it would collect opinions from seven drug companies on the approval conditions of their 25 products including linagliptin monotherapy and combo drugs by May 31.

lhs@docdocdoc.co.kr

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