The official letter 5749/QLD-ĐK updating Package insert of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
| MINISTRY OF HEALTH DRUG ADMINISTRATION — |
SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness —– |
| No. 5749/QLD-ĐK About updating Package insert of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) |
Hanoi, April 27, 2017 |
To:
– Departments of Health of provinces and cities under central authority;
– Hospitals and institutes with beds under the Ministry of Health;
– Establishments registering drug circulation in Vietnam.
Over the past years, Health Administration Authorities in the world has conducted an analysis and assessment of cardiovascular safety with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs). Based on the results of the research and analysis, Health Administration Authorities in the world (US FDA, EMA, TGA, Health Canada, HAS…) has requested updating drug labels and instructions for use (package insert) of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) to increase alertness for increasing the risk of severe cardiovascular events, including heart attacks and stroke, can lead to death as well as recommended use of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) at the lowest effective daily dose in the shortest possible time.
On December 14, 2015, the Drug Administration of Vietnam issued Official Letter No. 22982/QLD-TT providing information to health workers on the safety of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs).
Basing on the conclusions of the Advisory Councils for granting circulation registration numbers of the Ministry of Health, in order to ensure rational, safe and efficient use of drugs, the Drug Administration of Vietnam requests:
I. For provincial/municipal Health Departments and hospitals and institutes with beds under the Ministry of Health:
Continuing to inform the medical facilities, the above-mentioned pharmaceutical business units the warning information on cardiovascular events related to the use of non-aspirin NSAIDs in Official Dispatch No. 22982/QLD-TT dated 14/12/2015 of the Drug Administration of Vietnam and information, guidance in Annexes I, II and III attached herewith; At the same time, to enhance the monitoring of unwanted effects of drugs in the process of use and circulation; Send an ADR report (if available) to the National Center for Drug Information and Adverse Drug Reaction (13-15 Le Thanh Tong, Hanoi) or the Regional Center for Drug Information and Adverse Drug Reaction Ho Chi Minh City (201B Nguyen Chi Thanh, District 5, Ho Chi Minh City).
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- Side effects
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Cardiovascular Thrombosis: Clinical trials and epidemiological pharmacology studies have shown that the use of diclofenac is associated with an increased risk of cardiovascular events (such as myocardial infarction or stroke), particularly when diclofenac is administered at high doses (150 mg/day) and prolonged (see Warnings and Precautions).
The official letter 5749/QLD-ĐK updating Package insert of non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs)
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