The official letter 6922/QLD-ĐK updates pharmacological information for Testosterone-containing drugs

The official letter 6922/QLD-ĐK updates pharmacological information for Testosterone-containing drugs

To:
• Department of Health of provinces, centrally-affiliated cities
• Hospitals and institutes with beds under the Ministry of Health;
• Establishments registering drug circulation in Vietnam.

In October 2016, the US Food and Drug Administration (FDA) has approved the changes of drug labels and package insert of all prescription drugs containing testosterone to provide new information from medical literature and clinical reports on the risks associated with testosterone-dependent and abuse as well as other anabolic androgenic steroid hormones (AAS). Therefore, testosterone and other AAS when abused in adults and adolescents, including athletes and bodybuilders, are at higher doses than prescribed or combined with other AASs that cause serious risks on cardiovascular, brain, liver, mental and endocrine systems.
Prior to this, in March 2015, the US-FDA has issued a warning that prescription drugs containing testosterone were approved only for men with low testosterone levels caused by certain medical conditions. The efficacy and safety of these drugs in the treatment of patients with low testosterone levels due to aging, even in cases where relevant clinical symptoms have not been established. US-FDA has asked testosterone manufacturers to update their drug labels to clarify approved indications, while also adding information about the increased risk of myocardial infarction and stroke in patients taking testosterone.
Following Official Letter No. 2484/QLD-TT dated February 11, 2015 of the Drug Administration of Vietnam providing information to health workers on the safety and efficacy of testosterone drugs and basing on the conclusions of Advisory Council for granting drug circulation registration number -The Ministry of Health, in order to ensure the rational, safe and effective use of drugs, the Drug Administration of Vietnam requires:
I. For Department of Health of provinces, centrally-affiliated cities and hospitals; institutes with beds under Ministry of Health:
Continue to notify medical facilities, pharmaceutical business units in the areas about information related to recommendations mentioned in Official Letter No. 2484/QLD-TT dated 11/02/2015 of Drug Administration and contents of guidelines according to Annex of this official letter; At the same time, to enhance the monitoring of unwanted effects of drugs during use and circulation; send an ADR report (if available) to The National Center of Drug Information and Adverse Drug Reactions Monitoring (13-15 Le Thanh Tong, Hanoi) or the Regional Center of Drug Information and Adverse Drug Reactions Monitoring Ho Chi Minh City (201B Nguyen Chi Thanh, District 5, Ho Chi Minh City).
II. For drug registration establishments in Vietnam
1. For drugs containing testosterone were granted registration numbers.
• Within 3 months from the signing date of this official, request the drug registration establishments to perform updating, supplementing on sections: indication, dosage, warnings and cautions on the label, package insert the contents according to the appendix attached to this official letter.
• Update form: The drug registration establishment performs to automatically update according to the provisions of Clause 4, Article 9 of Circular No. 44/2014/TT-BYT dated November 25, 2014 guiding on drug registration by the Ministry of Health.
2. For testosterone-containing drug registration dossiers are waiting for approval at Drug Administration of Vietnam
The Drug Administration of Vietnam only consider and submit to the Advisory Council for granting drug circulation registration number after drug registration establishments submit document with the updated, supplemented contents on sections: indication, dosages, warnings and cautions, …according to the enclosed appendix of this letter to the relevant parts of the dossier and be evaluated satisfactory.
The Drug Administration of Vietnam informs units to know and implement.

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The official letter 6922/QLD-ĐK updates pharmacological information for Testosterone-containing drugs

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