Stop prescribing injectable medications containing the active ingredient Tolperison.
The Drug Administration of Vietnam (Ministry of Health) has issued a document requesting the suspension of circulation, recall, and immediate cessation of prescription nationwide of injectable drugs containing the active ingredient Tolperison, due to undesirable side effects.
Illustrative image. (Source: solarsystems-usa.info)
According to Deputy Director of the Drug Administration Department Nguyen Viet Hung, the request was made based on current Vietnamese pharmaceutical regulations; and based on the conclusion of the Ministry of Health's Drug Review Council on May 9, 2013, regarding the recall of injectable drugs containing the active ingredient Tolperison due to the risks outweighing the benefits of using this drug.
Therefore, to ensure user safety, the Drug Administration has suspended nationwide distribution and recalled all injectable drugs containing the active ingredient Tolperison.
Regarding injectable medications containing this active ingredient, nurse Nguyen Xuan Vinh from the Department of Cardiovascular and Thoracic Surgery at Viet Duc Friendship Hospital stated that injectable medications containing Tolperison are currently widely used in many hospitals.
“The reason is that the injectable medication contains the active ingredient Tolperison, which treats muscle diseases, spinal degeneration, joint pain, lumbar and cervical syndromes, vascular occlusion (atherosclerosis, etc.), as well as syndromes arising from impaired neurovascular distribution (cyanosis of the extremities, dyspnea due to neurovascular dysfunction). In particular, the medication contains these active ingredients to aid in rehabilitation after orthopedic and trauma surgeries,” nurse Vinh explained.
To ensure a thorough recall process, the Drug Administration of Vietnam requires importing and distributing companies of injectable drugs containing the active ingredient Tolperisone to coordinate with drug suppliers and distributors to send recall notices to all distributors and users of injectable drugs containing Tolperisone and to recall all of the aforementioned drugs nationwide.
The above units are required to submit recall reports and recall documents for injectable drugs containing the active ingredient Tolperisone to the Drug Administration of Vietnam before July 30, 2013, as stipulated by regulations.
In particular, Mr. Hung instructed hospitals and medical facilities with inpatient beds to immediately stop prescribing and using injectable drugs containing the active ingredient Tolperison and return the drugs to the distributors and suppliers.
Provincial and city health departments, and health departments of various sectors, are notifying businesses and users of the drug to cease use and recall injectable drugs containing the active ingredient Tolperisone.
Regarding supervision, the Drug Administration of Vietnam requests relevant authorities to inspect and monitor units implementing this notice and handle violations according to current regulations, reporting to the Drug Administration of Vietnam and other relevant agencies.
According to (Vietnam+) - LT
