Teva Ukraine

Metamizole: the risk of drug-induced liver injury. February 2021 Dear medical and pharmaceutical professionals, Teva Ukraine LLC, as the owner of registration certificates for medicinal products containing metamizole sodium - Spasmalgon®, tablets and Sedalgin Plus, tablets, in agreement with the European Medicines Agency (EMA) and the State Expert Center of the Ministry of Health of Ukraine informs you about the risk of drug-induced liver damage. Summary: Cases of drug-induced liver damage (DILP) have been reported after the use of metamizole. Advise patients on: early symptoms of drug-induced liver injury, discontinuation of metamizole if such symptoms occur and seeking medical attention to assess and monitor liver function; Metamizole should not be re-administered to patients with a history of liver injury during metamizole treatment for whom no other cause of liver damage has been established. The "Special Instructions" and "Side Effects" sections of the instructions for medical use of medicinal products containing metamizole will be updated accordingly. Reasons for the safety concern Metamizole is a non-opioid pyrazolone derivative with potent analgesic, antipyretic and weak anti-inflammatory properties. Metamizole is also present in fixed combination products, such as: metamizole sodium+pitophenone hydrochloride+fenpiverinium bromide, intended for adults and children over 15 years of age for symptomatic treatment of mild to moderate pain syndrome in spasms of smooth muscles of internal organs: renal colic and inflammatory diseases of the urinary tract, accompanied by pain and dysuric disorders; spasms of the stomach and intestines, hepatic colic, biliary dyskinesia; spastic dysmenorrhea; and metamizole sodium+caffeine+thiamine hydrochloride, intended for adults and children aged 12 years and older for symptomatic treatment of pain syndrome in migraine, tension headache; inflammatory and degenerative diseases of the musculoskeletal system; postoperative conditions; diseases of the peripheral nervous system (radiculitis, plexitis, neuritis, neuralgia, polyneuritis, polyneuropathy); dysmenorrhea. Recently discovered new information on liver damage prompted a full review of data relating to the potential of metamizole to cause MUP. During the review, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) reviewed information from all available sources, including reports of adverse drug reactions and studies published in the scientific literature. It was noted that liver damage is predominantly hepatocellular in nature and manifests itself within days or months after starting treatment. Signs and symptoms included elevated serum liver enzymes with or without jaundice, often in the context of other drug hypersensitivity reactions (e.g., skin rash, blood dyscrasia, fever, and eosinophilia) or accompanied by signs of autoimmune hepatitis. In some patients, liver damage was accompanied by recurrence with repeated use of metamizole. The mechanism of liver damage caused by metamizole is not clearly understood, but available data indicate an immunoallergic mechanism. Overall, drug-induced liver injury can progress to potentially serious consequences, such as acute liver failure requiring liver transplantation. Based on nearly 100 years of marketing experience with metamizole and the duration of its exposure to patients, cases of liver damage due to metamizole are considered very rare, but the exact frequency of this adverse reaction cannot be determined. Early detection of potential liver damage due to metamizole is important. Patients should be educated to watch carefully for symptoms of potential liver damage and encouraged to discontinue metamizole and seek medical attention if such symptoms occur. Healthcare professionals are advised to assess and monitor liver function in patients with signs and symptoms suggestive of any liver damage. Re-administration of metamizole-containing medicinal products is not recommended in the event of a previous case of liver damage that occurred during treatment with metamizole, for which no other cause of liver damage has been established. REPORTING OF ADVERSE REACTIONS Please report any suspected adverse reactions to the State Expert Center of the Ministry of Health of Ukraine by phone 044 202 17 00 or via the link https://aisf.dec.gov.ua/. If you have information about the occurrence of an adverse reaction or lack of effectiveness when using Teva's drug, please contact the company's pharmacovigilance department by phone +38050-462-17-67 or by e-mail Safety.Ukraine@teva.ua. If you have any questions or need additional information or medical clarifications regarding Teva drugs, you can contact the company's support center by phone 0-800-502-284, or the Medical Department by e-mail medinfo@teva.ua.