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Food and Drug Administration adverse drug reaction information bulletin
(H) the Department of health today (June 18) called on the public not to buy or take a marked “d c-yinqiao tablets” orally consumed products, because the product might contain a variety not shown and Western drug ingredients that have been disabled, after taking risks.
Received by the Department of health to the Hospital Authority (HA) announce a 41 year old female patient-related case, the investigation immediately, and the appeal was made.
The patient last October due to Rhabdomyolysis and hypokalemia were rushed to the Princess Margaret Hospital for medical treatment. Subsequently, the patients at the time of follow-up was found low blood potassium levels. She most recently in June when the follow-up to doctors who had taken the above products, clinical diagnostic doubts her symptoms may be caused by the drug-related adverse reactions.
HA today’s test results showed that the products containing two is not marked and Western drug ingredients that have been disabled, “non-Sittingbourne” and “pyramidon”. However, in marked on the bottles of the product components, including “vitamin c“, “p-b” and “chlorine stupid chlorphenamine maleate”, has not been found. Preliminary investigations found that patients purchase the products from the Mainland. Department of health does not have this record of products imported into Hong Kong for sale, nor their registration of the application record. Department of Health’s investigation continues.
Department of health spokesman said: “” the Sittingbourne “and” pyramidon “has been used as an analgesic, but it can cause serious side effects, has been banned in Hong Kong in 1983 and 1984 respectively. “Not that Sittingbourne” can lead to hemolytic anemia, modified sulfur blood heme and heme blood disease. “Pyramidon” will cause graininess deficiency of white blood cells. 」
Spokesman appealed to have purchased these products are advised to immediately stop taking it and advised the public not to buy or use ingredients or products of unknown origin. After taking the product if they are in doubt or feel uncomfortable, medical personnel should be consulted for advice. They can during office hours to the product under No. 213 Queen’s Road East, Wan Chai, 1856, Wu Chung House, the Department of Health Office of drugs destroyed.
On June 18, 2013 (Tuesday)
19:43 in Hong Kong
Food and Drug Administration: adverse drug reaction information bulletin (32nd)
Attention to Western medicine compound preparation d c-yinqiao tablets in security issues
Informed the current varieties of dimension c-yinqiao tablets, containing chemical vitamin c, Chlorphenamine maleate (also called chlorpheniramine), acetaminophen of 3 kinds of medicine compound preparation of traditional Chinese and Western medicine. Dimension c silver Alice tablets for non-prescription drug, patients can itself purchased drug, its clinical using widely, through national drug bad reaction monitoring center cases report database analysis displayed, the varieties exists must of security problem, is its drug bad reaction more for chemical components known of bad reaction, but public even medical workers may will ignored its contains of chemical components, which may brings additional of security risk.
Attention to Western medicine compound preparation d c-yinqiao tablets in security issues
D c-yinqiao tablets made from Honeysuckle flower, Forsythia, nepeta, SSP, arctium lappa, Campanulaceae, Mint oil, Reed Rhizome, pale leaves, licorice, vitamin c, chlorpheniramine maleate chlorpheniramine, paracetamol 13 ingredients made of compound preparation of traditional Chinese and Western medicine, has the effect of cooling solution table, clearing heat and detoxifying effect. For flu, fever, cough, headache, sore throat and dry mouth.
From January 1, 2004 to April 30, 2010, report on National Center for adverse drug reaction monitoring database for dimension c-yinqiao tablets in total, the number of reported cases in 1885, adverse drug reaction/event affects the central nervous system and peripheral nervous system, digestive system, skin and appendages. D c-yinqiao tablets reports a total of 48 cases of severe cases, 2.55% per cent of all reports, and no deaths have been reported.
First, the clinical manifestations of severe cases
Dimension c silver Alice tablets serious cases of bad reaction/event performance following: skin and the subsidiary device damage accounted for 75 estimated, performance for body sent rash type rash with itching, and serious urticaria, and heavy syndrome more shaped Erythema type drug eruption, and big blister sex epidermal pine solutions syndrome; digestive system damage accounted for 12.50 estimated, performance for liver function exception; body sex damage accounted for 10.1 estimated, performance for allergy sex shock, and allergy sample reaction, and fainting ; Urinary tract damage 4.17 per cent respectively, interstitial nephritis; hematological damage 4.16 per cent respectively, Leucopenia, haemolytic anaemia.
Case 1: the patient, male, 42 years old, “sore throat 1 day” since the purchase of dimension c-yinqiao tablets, occurred after oral administration of 2-hour “itchy skin, difficulty breathing, tightness in the chest”, and immediately a doctor. Physical examination: blood pressure 90/40 mmHg, pulse 104 times/min, not neat, bigeminal rhythm, Erythema skin rashes, pressure faded, two pulmonary breath sounds clear, irregular heartbeat, no smell and noise. Immediate injection 10 mg intravenous injection of dexamethasone, promethazine 25 mg intramuscularly injection, 250 ml +10% 5% glucose intravenous infusion of Calcium Gluconate for injection 20 ml, 1 hour later, symptoms, blood pressure 110/60 mmHg.
Case 2: patient, female, 33 years old, “fever, sore” to a drug store to buy vitamin c yinqiao tablets, orally 3 times/day, 3 tablets, 3 days after taking the medicine, the temperature is not reduced but increased to above 39 degrees, with anorexia, abdominal discomfort. Visiting the hospital, laboratory test report: ALT 364U/L, AST 189U/L turn 265U/L,r-glutamine peptide enzyme alkaline phosphatase 259U/L, 58.8 μ mol/l of total bile acid, lactate dehydrogenase 407U/L, hepatitis a antibodies, HCV antibody and HEV antibody negative. Before January examination in patients with normal liver function, hepatitis b surface antibody positive. Disable all drugs, chuipencao granules, oral liquid of inosine, vitamin c, and three months later liver function was normal.
B, Super manual analysis
D c-yinqiao tablets in the National Center for database analysis of adverse reaction/event reporting showed that Super with the product instructions, mainly as follows:
1. Is not used according to the instructions the recommended dosage
D c-yinqiao tablets instructions note: for adults, 2 tablets, 3 times a day; the National Center received about 14% in the case of using c-yinqiao tablets in patients with 3-4 tablets, 3 times daily.
Case 3: patient, male, 38 years old, for “cold” to the local clinic, dimension c-yinqiao tablets 3 times per day, each 4. 3 days later, the patients generalized Erythema, conscious slight itching. Visiting the hospital, examination: t-36.8 ℃, p 88 beats/min, BP 152/82mmHg, sane legs torso generalized Erythema, some fusion, blanch on pressure, between rice and bean size, skin temperature is not high. Diagnosis: eruptive type eruption. Intravenous infusion of methylprednisolone Ronson 20mg, clarityne 10mg oral treatment patients improved and discharged.
2. Combined use with the composition similar to that of other drugs
D c-yinqiao tablets instructions note: this product is not taken with this product ingredients similar to those of other cold medicine. National Center of vitamin c-yinqiao tablets received serious cases have been reported in some cases combined with other ingredients like cold medicine.
Case 4: patient, male, 8 years old, “fever, sore” c-yinqiao tablets and oral dimension Bufferin (generically as acetaminophen) 3 days later, lips erosion occurs, with pain, torso, limbs scattered red spots with itching occurs, the temperature began to rise to 39 c, visiting the hospital. Body: the face, limbs, trunk, edematous red stains in 0.3-1.0CM size, round or oval. Methyl-prednisolone, amber acid-hydrocortisone hydrocortisone, prednisone, 10 days after recovery.
3. Allergies to ingredients contained in this product use.
Vitamin c in yinqiao tablets instructions hint: disabled for this allergy, allergy with caution. National Center for database analysis shows that individual patients with allergies to ingredients contained in this product, serious adverse reactions after use.
Case 5: patient, male, 28 years old, due to “sense” take dimension c-yinqiao tablets and granules of radix isatidis, after medication the next day found his hands arms, both lower limbs, chest back and part of the scrotum several circle purple patch, diameter 3-6cm, itching, pain-free, without seeing a doctor. Some purple-patch Center on the third day with a blister, blister diameters up to approximately 2cm, blister wall is thin and break, scrotal erosion occurs, and treatment in the Emergency Department, diagnosed as “type of drug eruption of Erythema Multiforme”, patients with a history of penicillin, allergy to acetaminophen, income to hospital for further diagnosis and treatment. Admission to methyl-prednisolone after intravenous infusion of 40mg, Loratadine 1 10mg1 days, Berberine liquid, boric acid topical treatment such as wet, 10 days after the condition is improving significantly, a blister scab, erosion of seepage reduction, improved and discharged.
Third, the analysis of factors influencing d safety c-yinqiao tablets
Dimension c silver Alice tablets is by 13 taste drug made of in the Western medicine compound preparations, its by containing components on acetyl amino phenol (and said “bashing hot card pain”) of bad reaction main performance for rash, and urticaria, and drug hot, and liver kidney function damage and serious allergy reaction,; its by containing components Malay acid chlorobenzene brompheniramine (and said “bashing, sensitive”) of bad reaction main performance sleepy, and weak sense, and for addicted to sleep, and mouth dry, and throat pain, and palpitations,. At present, the National Center for database-d c-yinqiao tablets case analysis, the product safety issue related to its contained components has some relevance.
Four, the related recommendations
1. Recommended a doctor’s prescription or pharmacy sell drugs, tips-d c-yinqiao tablets of compound preparation of traditional Chinese and Western medicine, the product contains chlorpheniramine maleate chlorpheniramine, paracetamol and vitamin c. Allergies to ingredients contained in this product are disabled, allergy with caution. Taking this products during shall not drinking or contains alcohol of beverage; shall not while taking and this products ingredients similar of other anti-cold drug; liver, and kidney function damaged who caution with; bladder neck obstruction, and thyroid function hyperthyroidism, and glaucoma, and hypertension and prostate mast who caution with; pregnant women and the lactation women caution with; medication during shall not driving machine, and car, and ship, shall not engaged in Spider-man, and mechanical job and the operation precision instruments.
2. Recommended strictly according to the instructions use, avoid overdosing, long-term medication, medication should be closely observed, skin itching, rashes, breathing difficulties and other allergy symptoms should immediately stop taking the pill in early and timely treatment or medical attention immediately; emergence of appetite, urine yellow, yellow skin and other symptoms should immediately stop taking the pill, timely treatment, and monitoring of liver function.
3. Recommended that manufacturers should improve the product instruction manuals and packaging, labeling, increase information relating to security and strengthening post-marketing studies to ensure that product safety information is communicated in a timely manner to both patients and physicians.
Dimension c silver Alice tablets found containing toxic Shi long: 2’4” play: 134lai source: Tencent video dimension c silver Alice tablets found containing toxic received up Guangdong Jieyang dimension c silver Alice tablets containing HIV enterprise was revoked practice card Guangdong Baoshan Hall suspected counterfeiting dimension c silver Alice tablets lost pharmaceutical qualification dimension c silver Alice tablets raw materials fraud Baoshan Hall was pin license full discontinued
The article collected by HealthyFoodCN.