Opinion of the Drug Administration: information that domperidone increases the risk of sudden death
The Drug Administration of Vietnam has just issued an official dispatch requesting that information related to drug use be accurate, scientific and complete after some media reported that domperidone increases the risk of heart rhythm disorders and sudden death.
Regarding some media reports that drugs containing the active ingredient Domperidone can increase the risk of heart rhythm disorders and sudden death due to heart disease, the Drug Administration of Vietnam said that monitoring and updating information on adverse drug effects is a routine activity of management units in general and the pharmaceutical industry (worldwide) in particular.
In Vietnam, drug information and adverse drug reaction monitoring centers (National Center located at Hanoi University of Pharmacy and Ho Chi Minh City Regional Center located at Cho Ray Hospital), Clinical Pharmacology Center (located at Hanoi Medical University) are responsible for collecting, analyzing, evaluating, and synthesizing warnings about adverse drug reactions from international organizations, inventors, manufacturers, registrants and domestic treatment facilities, then reporting to the state management agencies of Pharmacy in Vietnam so that the management agencies can take appropriate measures as well as notify treatment facilities about adverse drug reactions. This is one of the routine activities in the Pharmacovigilance system of the Ministry of Health of Vietnam.
Every year, the Drug Review Advisory Council - Ministry of Health updates hundreds of warnings related to adverse drug reactions for health workers to ensure safe, rational and effective use of drugs for people.
For example, after just one meeting of the Drug Review Advisory Council in July 2013, the Drug Administration issued Official Letter No. 12352/QLD-TT dated July 31, 2013 requesting the Department of Health of provinces and centrally-run cities and hospitals and institutes with beds under the Ministry of Health to notify medical examination and treatment facilities and pharmaceutical business units in the area of warnings related to adverse reactions of 8 types of drugs, including drugs containing the active ingredient Domperidone. Then, on October 22, 2013, the Drug Administration issued Official Letter No. 17560/QLD-DK to companies registering and manufacturing drugs circulating in Vietnam requesting to update pharmacological information for drugs containing the active ingredient Domperidone in the sections Contraindications, Undesirable effects, Dosage, Precautions and special warnings when using the drug in the Instructions for use of the drug to minimize the risk of arrhythmia and sudden death due to cardiovascular disease related to the use of this drug.
With any medicine, in addition to the therapeutic effect, all medicines have the risk of causing side effects for patients, depending on the patient's condition, constitution, drug interactions, etc. Only doctors and specialists can determine the benefits/risks of each medicine for each patient.
Thus, if only providing information about the harmful effects of drugs without accompanying full instructions for use, including: users, dosage - usage, contraindications, notes, precautions when using drugs, analysis of benefits/risks of drugs... will cause people to misunderstand, leading to confusion, anxiety, and even fear of using drugs.
Therefore, the Drug Administration of Vietnam recommends that newspapers consult with the Drug Administration's professional staff to provide accurate, complete, scientific and comprehensive information, contributing to improving the safe, reasonable and effective use of drugs for the people in general and avoiding affecting the production, circulation and distribution situation in particular.
According to Dan Tri