Recently, the Drug Administration of Vietnam Ministry of Health has decided to revoke the circulation certificate and recall the drugs circulating on the market for drugs containing the active ingredient rosuvastatin 40mg, because the drug is contraindicated for asians.
In Vietnam there are 4 medicines that contain the active ingredient rosuvastatin 40 mg, namely:
– Rofast 40 (active ingredient, content of rosuvastatin in the form of rosuvastatin calcium) 40 mg. Film-coated tablets. Phone Number: VN-22058-19.
– Lipidorox 40 mg (active ingredient, Rosuvastatin content 40 mg). Film-coated tablets. Item number: VD-1507-06
– Crestor (active ingredient, rosuvastatin calcium content 40 mg rosuvastatin). Film-coated tablets. Phone Number: VN-8438-09
– Avitop 40 (active ingredient, content of rosuvastatin in the form of rosuvastatin calcium 40 mg). Film-coated tablets. Register: UN-19620-16.
The Ministry of Health requires drug registries and importers to cooperate with manufacturers in sending recall notices to wholesalers, retailers and users of drugs and recalling drugs containing said active ingredients. above.
Submit a recall report to the Drug Administration of Vietnam by May 1.
The ministries of health of the provinces, cities and health departments will notify the establishments that trade, use and recall the above drugs and publish information about the drug recall decision on the ministry’s website. Inspect and supervise the units executing this decree, treat the offending units according to current regulations. Report to the Drug Administration of Vietnam and relevant authorities.
|Rosuvastatin (brand name crestor) is a medication for primary hypercholesterolemia or mixed dyslipidemia (type IIB). Rosuvastatin should be administered with caution to patients with a history of liver disease, predisposing factors for rhabdomyolysis such as renal failure, hypothyroidism, personal or family history of hereditary muscle disease, alcoholics, over 70 years of age. , conditions that cause increased blood levels of the drug, concomitantly with fibrates.
Side effects when taking the drug may include headache, dizziness, constipation, nausea, abdominal pain, weakness. Some cases cause itching, rash, urticaria. Rare cases of hypersensitivity including angioedema, myopathy, rhabdomyolysis, arthralgia, elevated liver enzymes. In addition, very rarely jaundice, hepatitis, polyneuropathy.