Remind: He may cause the serious liver to damage the risk to watch out for Olli department

Remind: He may cause the serious liver to damage the risk to watch out for Olli department
Remind: He may cause the serious liver to damage the risk to watch out for Olli department
The core treats the fat medicine to briefed him on Olli department, because has found the rare but serious liver to damage while monitoring after listing, American food medicines administration bureau (FDA) Have warned him there will be risk that may have caused the serious liver to damage in May of 2010. Though can't establish and use Olli department yet he and serious liver damage the concerned withing among the risk, and there is few case found at present, but in order to make medical workers and consumers understand using the risk of this medicines in time, national the intersection of medicines and bad reaction monitoring center release the intersection of medicines and the intersection of bad reaction and information, notify on will it be March 4 2011 year ' The 36th issue) ,Notify his security information of Olli department. While notifying, the national medicines bad reaction monitoring center has reviewed FDA relevant assessment information to this medicine, and his bad reaction of Olli department of our country reports the situation and relevant measure taken, and proposed the relevant suggestion of using medicine. He of his basic situation Olli department of Olli department is long-efficiency specific gastrointestinal lipase inhibitor, can prevent triglyceride from hydrolyzing for absorptive free fatty acid and single acyl base glycerine, make it not absorbed, thus reduce heat to take in and control the weight. He, department of Olli, combine low the intersection of heat energy and diet it suitable for fat and weights to be getting overweight to include those appear with to treat for a long time fat relevant dangerous patient of factor already a little. Olli department his grinds enterprises as Luo's company originally. His capsule of Olli department of its production has 2 specifications in all: 120mg specification was listed on Argentina at first in 1997, already over 100 countries have been criticized in the whole world so far, Australia, New Zealand, Thailand, Singapore, Philippine, Malaysia, Ukraine, Peru manage it as non-prescribed medicine; 60mg specification is sanctioned being listed as non-prescribed medicine by FDA on February 7, 2007. Managed in more than 40 countries including European Union as non-prescribed medicine hereafter. There is no imitation medicine to list abroad in this medicines. Luo his capsule of Olli department of company's production (120mg, goods name: Can comparable to the Buddhist nun) Listed on our country in 2000, changed into non-prescribed medicine at the end of 2005, the card was that its non-prescribed medicine adapted to: Used in the fat or overweight patient of weight ' The weight index is greater than or equal to 24) Treatment. November of 2009 begins, because of the commercial reason, Luo's company stops his capsule ( 120mg) of Olli department Sale in our country. At present, there is modelling medicines and has already been criticized and has gone on the market of two manufacturing enterprises at home, it is his capsule and tablet ( 120mg) of Olli department respectively ,Olli manages he ( 60mg) Preparation has not been criticized and has gone on the market yet in our country. FDA damage May of 2010 of assessment of the risk to serious liver their, FDA announces warning, warns that he may cause the rare but serious liver to damage the risk to use reducing weight in medicine Olli department. The warning message claims, FDA damaged the data to his liver of Olli department to carry on the overall assessment, confirm, use the intersection of Olli and department take place at the he serious liver damage the case and amount to 13 from 1999 to will it be August 2009, because the depleted death of liver that among them there are 2 examples, 3 need liver transplantation. Seeing that 40 million people have used Olli department, he during this period, some cases of damaging the liver at the same time have also used other medicines or patients to have other situations that may cause the liver to damage, use patient of medicine might present the intersection of reason and unidentified serious the intersection of liver and the intersection of person who damage and consideration of factor too, FDA shows, still unable to set up liver to damage with Olli department at present. But consider the severity of the bad incident here, FDA has already required enterprises to add the liver into manual and damage case information, physical sign and symptom in order to make the patient understand liver and damage, go to see doctor in time if necessary. The domestic bad reaction monitors the situation until December 31, 2010, about more than 120 case reports of his of Olli department in the case report database of monitoring center of bad reaction of national medicines, the main bad reaction is shown as constipation, abdominal pain, diarrhoea, dizzy, period disorder, rash,etc.. In his case report of Olli department, the hepatobiliary system damages 6, is shown as unusual 4 of liver function, liver district pain 1, medicine 1 of hepatitis. The case mainly comes from the monitoring data of pharmacy enterprises, it has fatty liver etc. to mix the factor to share other medicines or patient that some cases exist. Of our country supervision department adopt relevant will it be September 1 2010 such as measure, national the intersection of food and medicines supervise administration bureau after not damaging the issue and carrying on the assessment to him of Olli department liver, announce " notice on revising his preparation manual of Olli department " ' The country eats medicines and supervises the note [2010 ] for the 359th) ,Require the following contents in his preparation manual of domestic Olli department to upgrade: Manual [bad reaction ] item upgrade for " use he, department of Olli, for rare the intersection of transaminase and raise, the intersection of alkaline phosphatase and raise and severe report of hepatitis, and the depleted case of liver appears, it may cause the death directly that some patients among them need to carry on liver transplantation. The report of rare allergic response takes place in he in Olli department, main clinical manifestation, for pruritus, rash, urticaria, blood vessel nerve hydropic, bronchospasm and allergic reaction, it is very rare to present great bleb. Monitor and also find the report with pancreatitis after being listed. " Manual [attentive matters ] the intersection of project and relevant content upgrade until " he take place list, rare acute the intersection of hepatocyte and necrosis or acute the intersection of liver and depleted serious liver decrease because of the intersection of Olli and department Injure the report, it may cause the death directly that some cases among them need to carry on liver transplantation, so prescription doctor should instruct patient report to, take Olli department appear the intersection of liver function and the intersection of obstacle and symptom and physical sign any behind the he voluntarily ' If appetite fail and pruritus, jaundice, urine color dark and excrement and urine color shallow and the quadrant pains in right) . When any aforesaid symptom appearsing, should immediately inactive the intersection of Olli and the intersection of department and he and other suspicious medicines, and examine liver function. " Propose notifying that advises consumers to read the manual carefully, define the fat applicable scope of his treatment of Olli department (weight index is greater than or equal to 24) in relevant administration ,Stop unreasonable to use medicine; He pay attention to combining sports and keeping on a diet while treating fatly to know and use Olli department correctly, could reach the good result; Should notice to the fat complication ' For instance hypertension, hyperlipemia, diabetes,etc.) Monitoring sum treatment; At the time of liver damaging and relevant symptom of other serious bad reactions described in presenting the manual, should seek medical advice in time. Advise doctor and pharmacist to instruct the patient how to use medicine correctly according to the manual, pay attention to patient's symptom correlated to serious bad reaction takes place while using medicining, find that should check and treat, report the bad reaction case the national medicines bad reaction to monitor the database at the same time in time. It is relevant to propose The medicines manufacturing enterprise will use medicine the risk will be told a medical worker, will strengthen consumer's education, instruct consumers he treat self- medicine to use Olli department correctly. Strengthen the monitoring of bad reaction at the same time, take effective risk control measures, reduce the repetition of the bad reaction to the maximum extent? �? (food medicines of comprehensive country supervise the websites of administration bureau and website's information of monitoring center of bad reaction of national medicines) Relevant while chaining he of his bad reaction Olli department of Olli department and is used for treating fatly and overweightly, the common bad reaction reacts for the gastrointestinal tract, this relates to the fact that the medicine stop taking in the pharmacology function of absorption of the fat. Shown as: Oily spot, it is angry to increase for intestines and stomach to arrange, the urgent sense of stool, the fat (oil) The intersection of sex and stool, fat rush down, number of times of the stool increase and stool incontinence. The other bad reactions rarely observed are as follows, upper airway infection, making airway infection, influenza, having a headache, menoxenia, anxious, tired, urinary tract to infect. Monitor finding, he have reports of rare transaminase raising, alkaline phosphatase raising and severe hepatitis to use Olli department after being listed, and the depleted case of liver appears, it may cause the death directly that some patients among them need to carry on liver transplantation, concerned withing when can't confirm using Olli department his and serious liver damaging yet at present. The report of rare allergic response takes place in he in Olli department, main clinical manifestation, for pruritus, rash, urticaria, blood vessel nerve hydropic, bronchospasm and allergic reaction, it is very rare to present great bleb. The bad reaction monitors and also finds the report with pancreatitis after being listed.


|