The State Food and Drug Administration (CFDA) has released the 63rd issue of Adverse Drug Reaction Information Bulletin, this time for propylthiouracil. Propylthioxypyrimethamine is a thionamide antithyroid drug, which can inhibit thyroid peroxidase, thus blocking thyroid hormone production.
Analysis of the National Adverse Drug Reaction Monitoring Database suggests that there has been an increase in the number of adverse reactions to propylthiouracil recently. The three most common systems reported as serious adverse reactions are damage to the hepatobiliary system, abnormalities of the leukocyte and reticuloendothelial systems, and damage to the skin and its adnexa, in addition to reports of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis that were not indicated in the instructions. In order to inform medical professionals, drug manufacturers and the public about the safety issues of this class of drugs, to guide the rational clinical use of drugs and to reduce the risk of drug use, this species is notified in a special issue.
Be aware of serious adverse reactions to propylthiouracil
Propylthiouracil is a thioamide drug that inhibits thyroid peroxidase, thereby blocking thyroid hormone production, and is mainly used to treat hyperthyroidism in adults. In 2013, 432 adverse reactions to propylthiouracil were reported in the National Adverse Drug Reaction Monitoring Database, including 99 serious adverse reactions, and the top two serious adverse reactions by system were hepatobiliary system damage and leukocyte and reticuloendothelial system abnormalities, accounting for 71.5% of the total number of cases. In addition, five cases of anti-neutrophil antibody (ANCA)-associated vasculitis were reported.
I. Serious adverse effects of propylthiouracil
(A) Hepatobiliary system damage and abnormalities of leukocytes and reticuloendothelial system
Among the serious adverse reactions, hepatobiliary system damage and leukocyte and reticuloendothelial system abnormalities accounted for the highest proportion, mainly manifested as abnormal liver function, hepatocyte damage, hepatitis, elevated bilirubin, leukopenia and granulocyte deficiency, etc. Most of these reactions occurred within the first three months of drug administration, and can be diagnosed by routine blood and liver biochemical examination.
(ii) Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
ANCA-associated vasculitis is a disease marked by inflammation and necrosis of small and medium-sized blood vessels, which has an insidious onset and can involve multiple organs and systems throughout the body, such as the kidneys, lungs and joints. Involvement of the kidney often manifests as hematuria, proteinuria, renal insufficiency and even renal failure; involvement of the lung often manifests as cough, hemoptysis and intra-pulmonary shadow; involvement of the joint may manifest as joint pain and swelling, etc. ANCA-associated small vessel vasculitis caused by propylthiouracil is mainly seen in patients on long-term medication.
II. Related recommendations
(a) Medical personnel should inform patients of possible adverse reactions in a timely manner. Patients taking propylthiouracil should have their blood and urine routines, liver and biochemical parameters and kidney functions checked regularly and seek medical attention if adverse reactions occur.
(b) Drug manufacturers should strengthen the monitoring of adverse drug reactions, promptly revise the drug instructions of propylthiouracil, update relevant information on the risks of drug use such as adverse reactions, precautions, etc., inform medical personnel and patients of the risks of propylthiouracil in an effective manner, and increase the publicity of rational drug use to maximize the safety of drug use for patients.
Questions and Answers.
1.What is propylthiouracil and what kind of diseases is it mainly used to treat?
A: Propylthiouracil is a thioamide drug with a mechanism of action similar to that of methimazole, which inhibits thyroid peroxidase, thereby blocking thyroid hormone production, and is mainly used to treat hyperthyroidism in adults.
2.What are the main serious adverse reactions caused by propylthiouracil?
A: Serious adverse reactions caused by propylthiouracil include abnormal liver function, hepatocellular damage, hepatitis, elevated bilirubin, leukopenia, granulocyte deficiency, etc., which mostly occur within the first three months of use. Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, manifested as acute glomerulonephritis or even acute renal failure, as well as pulmonary infiltration or alveolar hemorrhage, skin ulcers and joint pain, are mostly seen in patients who have been using the drug for a long time.
3.What is anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis?
A: ANCA-associated vasculitis is an autoimmune disease marked by inflammation and necrosis of small and medium-sized blood vessels, with anti-neutrophil cytoplasmic antibodies (ANCA) as an important serological diagnostic basis. It mainly involves organs and tissues rich in small blood vessels, such as kidneys, lungs, joints, muscles and skin, and manifests as proteinuria, hematuria, renal insufficiency and renal failure; cough, hemoptysis, chest tightness, intrapulmonary shadow; joints, muscle pain and rash, purpura, maculopapular rash and even skin ulceration and necrosis. The clinical diagnosis mainly relies on serological findings and histopathological examination results.
4.What do I need to pay attention to when using propylthiouracil?
A: The doctor should inform the patient of the possible adverse reactions when taking propylthiouracil and instruct him/her to regularly check the blood routine, urine routine, liver biochemical index and kidney function, and pay attention to the physical changes, such as fever, headache, loss of appetite, nausea, vomiting, fatigue, itching, pain or pressure in the right upper region of the abdomen, dark (tea-colored) urine, yellowing of the skin or whites of the eyes, light-colored intestinal excretion, muscle and joint pain, and edema and other symptoms, you should seek prompt medical attention.