Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
February 20, 2010, 13:45:32 – CNA, Xia Mingzhu
A confidential report from the U.S. Food and Drug Administration (FDA) recommends that the U.S. government order the diabetes drug Avandia, produced by GlaxoSmithKline, to be withdrawn and banned from sale due to its potential harm to the heart.
The confidential report obtained by The New York Times states that if diabetic patients currently using Avandia in the U.S. were to switch to other medications, it could potentially reduce an estimated 500 heart attack cases and 300 heart failure cases each month.
Avandia was once the second-best-selling drug for GlaxoSmithKline, but its sales plummeted two years ago after U.S. studies suggested it might increase the risk of heart attacks.
In 2007, the FDA voted 8 to 7 to accept the advisory committee's recommendation, which concluded that although Avandia might raise the risk of heart attacks, it was not severe enough to warrant mandatory withdrawal from the market.
Source: http:/ / news. pchome. com. tw/ li……ex- 12666447320570221009. html
【United Daily News / Compiled by Wang Lijuan and Liu Huimin】
Nearly 100,000 diabetes patients in Taiwan take the popular British-made diabetes drug "Avandia" (rosiglitazone) produced by GlaxoSmithKline. According to a confidential U.S. government report, the drug may harm patients' hearts and should be withdrawn from the market.
Avandia, used to treat type 2 diabetes, is an insulin sensitizer containing rosiglitazone. Medical experts estimate that the drug holds about an 8% market share domestically, meaning roughly one in every 11 or 12 diabetes patients in Taiwan takes it. Currently, there are about 1 million diabetes patients in Taiwan.
A confidential internal report from the U.S. Food and Drug Administration (FDA), obtained by The New York Times, indicates that hundreds of Avandia users experience unnecessary heart attacks or heart failure each month. The drug is believed to be linked to 304 deaths in the third quarter of 2009. Once GlaxoSmithKline’s second-best-selling drug, with sales reaching $3.2 billion in 2006, Avandia’s sales began declining two years ago after a Cleveland study claimed it increased the risk of heart attacks.
In a jointly authored report, two FDA experts, Graham and Gelperin, concluded: "Rosiglitazone should be withdrawn from the market."
The New York Times reported that GlaxoSmithKline declined to comment on the FDA’s internal report. The company has consistently refuted claims that Avandia increases the risk of heart attacks, insisting there is no scientific evidence to support such claims. It is currently recruiting patients for long-term clinical trials to determine whether Avandia harms the heart.
Dr. Cai Shize, an attending physician in the Metabolism Department at Taipei Veterans General Hospital, noted that no European or American country has officially demanded Avandia’s withdrawal. The confidential report is part of a year-long investigation by the U.S. Congress and does not represent a final conclusion. The FDA has agreed to convene a committee this summer to discuss and make a decision. Currently, there are no updated research findings or conclusions. Dr. Cai personally has not encountered any domestic cases of similar complications.
Kang Zhaozhou, Director of the Food and Drug Administration under Taiwan’s Department of Health, stated that according to domestic adverse drug reaction reports, there have been 43 cases of mild side effects such as drowsiness over the past decade, and one case of myocardial infarction in 2007. The Department of Health will closely monitor any new international studies or reports before deciding on further action.
Source: http://udn. com/ NEWS/ HEALTH/ HEA1/ 5430230. shtml
FDA Secret Files: Diabetes Drug Avandia Harms Heart, Recommends Recall
A confidential report from the U.S. Food and Drug Administration (FDA) recommends that the U.S. government order the diabetes drug Avandia, produced by GlaxoSmithKline, to be withdrawn and banned from sale due to its potential harm to the heart.
The confidential report obtained by The New York Times states that if diabetic patients currently using Avandia in the U.S. were to switch to other medications, it could potentially reduce an estimated 500 heart attack cases and 300 heart failure cases each month.
Avandia was once the second-best-selling drug for GlaxoSmithKline, but its sales plummeted two years ago after U.S. studies suggested it might increase the risk of heart attacks.
In 2007, the FDA voted 8 to 7 to accept the advisory committee's recommendation, which concluded that although Avandia might raise the risk of heart attacks, it was not severe enough to warrant mandatory withdrawal from the market.
Source: http:/ / news. pchome. com. tw/ li……ex- 12666447320570221009. html
Diabetes Drug Avandia May Harm Heart
Nearly 100,000 diabetes patients in Taiwan take the popular British-made diabetes drug "Avandia" (rosiglitazone) produced by GlaxoSmithKline. According to a confidential U.S. government report, the drug may harm patients' hearts and should be withdrawn from the market.
Avandia, used to treat type 2 diabetes, is an insulin sensitizer containing rosiglitazone. Medical experts estimate that the drug holds about an 8% market share domestically, meaning roughly one in every 11 or 12 diabetes patients in Taiwan takes it. Currently, there are about 1 million diabetes patients in Taiwan.
A confidential internal report from the U.S. Food and Drug Administration (FDA), obtained by The New York Times, indicates that hundreds of Avandia users experience unnecessary heart attacks or heart failure each month. The drug is believed to be linked to 304 deaths in the third quarter of 2009. Once GlaxoSmithKline’s second-best-selling drug, with sales reaching $3.2 billion in 2006, Avandia’s sales began declining two years ago after a Cleveland study claimed it increased the risk of heart attacks.
In a jointly authored report, two FDA experts, Graham and Gelperin, concluded: "Rosiglitazone should be withdrawn from the market."
The New York Times reported that GlaxoSmithKline declined to comment on the FDA’s internal report. The company has consistently refuted claims that Avandia increases the risk of heart attacks, insisting there is no scientific evidence to support such claims. It is currently recruiting patients for long-term clinical trials to determine whether Avandia harms the heart.
Dr. Cai Shize, an attending physician in the Metabolism Department at Taipei Veterans General Hospital, noted that no European or American country has officially demanded Avandia’s withdrawal. The confidential report is part of a year-long investigation by the U.S. Congress and does not represent a final conclusion. The FDA has agreed to convene a committee this summer to discuss and make a decision. Currently, there are no updated research findings or conclusions. Dr. Cai personally has not encountered any domestic cases of similar complications.
Kang Zhaozhou, Director of the Food and Drug Administration under Taiwan’s Department of Health, stated that according to domestic adverse drug reaction reports, there have been 43 cases of mild side effects such as drowsiness over the past decade, and one case of myocardial infarction in 2007. The Department of Health will closely monitor any new international studies or reports before deciding on further action.
Source: http://udn. com/ NEWS/ HEALTH/ HEA1/ 5430230. shtml