Recently, the Drug Administration of Vietnam, the Ministry of Health has decided to revoke the certificate of circulation and recall the drugs circulating in the market for drugs containing the active ingredient rosuvastatin 40 mg because the drug is contraindicated for Asians.
In Vietnam, there are 4 drugs containing the active ingredient rosuvastatin 40mg, which are:
– Rofast 40 (active ingredient, Rosuvastatin content in the form of Rosuvastatin calcium) 40mg. Film-coated tablets. Phone number: VN-22058-19.
– Lipidorox 40mg (active ingredient, Rosuvastatin content 40 mg). Film-coated tablets. SKU: VD-1507-06
– Crestor (active ingredient, Rosuvastatin calcium content 40mg Rosuvastatin). Film-coated tablets. Phone number: VN-8438-09
– Avitop 40 (active ingredient, Rosuvastatin content in the form of Rosuvastatin calcium 40mg). Film-coated tablets. Register: VN-19620-16.
The Ministry of Health requires drug registration and import establishments to coordinate with manufacturers in sending recall notices to drug wholesalers, retailers, and users, and recall drugs containing the mentioned active ingredients. above.
Submit a recall report to the Drug Administration of Vietnam before May 1.
The Departments of Health of the provinces, cities, and health departments shall notify the establishments trading, using and recalling the above-mentioned drugs, and publicizing information about the drug recall decision on the Department’s website. Inspect and supervise the units implementing this decision, handle the violating 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 llB). Caution should be taken when administering rosuvastatin 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, concurrently with fibrates.
Side effects when taking the drug can 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. |
Source: Suckhoedoisong.vn
Source: Vietnam Insider