2:48 am, August 05, 2014
The Yomiuri Shimbun Fifteen hepatitis C patients who were prescribed a drug manufactured by Mitsubishi Tanabe Pharma Corp. have died after developing serious side effects such as liver failure and whole-body dermatitis, according to the drug company and other sources.
About a quarter of the patients who took Telavic, a drug for hepatitis C also sold under the generic name Telaprevir, suffered serious side effects after the drug went on the market in 2011. Mitsubishi Tanabe Pharma, based in Chuo Ward, Osaka, produces and sells Telavic.
Medical experts had pointed out the risk of side effects during clinical tests before the drug was released onto the market. Because of such concerns, it was prohibited to prescribe the drug to liver cancer patients and those who suffer from serious liver cirrhosis.
But in many of the fatal cases, the medicine was prescribed according to doctors’ judgment to patients for whom it was inappropriate.
According to the company, 11,135 people were prescribed the medicine from November 2011, when it went on sale, to September of last year. Among them, 2,588 people, or 23 percent, suffered serious side effects.
Of them, 13 died of liver failure, skin inflammation, kidney disorders or other conditions. By February of this year, two more had died. In all of the fatal cases, medical experts voiced suspicion that the medicine’s side effects had a causal relationship with the deaths.
Because the serious side effects had often been seen during Telavic’s clinical tests, the Health, Labor and Welfare Ministry ordered the company to set up a third-party committee when releasing the drug. The committee found that the medicine had been prescribed to patients who should not have received it.
According to the committee’s report, one doctor began prescribing the medicine to an elderly woman had previously been diagnosed with liver cirrhosis. Though she developed symptoms such as loss of appetite, the treatment continued for about three months.
About a quarter of the patients who took Telavic, a drug for hepatitis C also sold under the generic name Telaprevir, suffered serious side effects after the drug went on the market in 2011. Mitsubishi Tanabe Pharma, based in Chuo Ward, Osaka, produces and sells Telavic.
Medical experts had pointed out the risk of side effects during clinical tests before the drug was released onto the market. Because of such concerns, it was prohibited to prescribe the drug to liver cancer patients and those who suffer from serious liver cirrhosis.
But in many of the fatal cases, the medicine was prescribed according to doctors’ judgment to patients for whom it was inappropriate.
According to the company, 11,135 people were prescribed the medicine from November 2011, when it went on sale, to September of last year. Among them, 2,588 people, or 23 percent, suffered serious side effects.
Of them, 13 died of liver failure, skin inflammation, kidney disorders or other conditions. By February of this year, two more had died. In all of the fatal cases, medical experts voiced suspicion that the medicine’s side effects had a causal relationship with the deaths.
Because the serious side effects had often been seen during Telavic’s clinical tests, the Health, Labor and Welfare Ministry ordered the company to set up a third-party committee when releasing the drug. The committee found that the medicine had been prescribed to patients who should not have received it.
According to the committee’s report, one doctor began prescribing the medicine to an elderly woman had previously been diagnosed with liver cirrhosis. Though she developed symptoms such as loss of appetite, the treatment continued for about three months.
Although the hepatitis virus could no longer be detected in her body, she died of acute liver failure.
In the case of a man in his 60s, he developed symptoms such as skin inflammation immediately after he began taking the medicine, and the symptoms initially disappeared. But he redeveloped the symptoms on the 50th day after starting to take the medicine, and his condition got worse and worse. Finally, he died due to sores all over his body.
The committee decided it was possible that his doctor had overlooked signs of side effects from the medicine.
Clinical tests have found that side effects of the medicine can be prevented from worsening if doctors monitor skin conditions carefully. Thus the ministry limited authorization to prescribe the medicine to about 800 medical institutions with doctors that specialize in liver and skin diseases.
According to the company, there were problems aside from the fatalities. For example, there were cases in which patients who took the medicine developed skin symptoms—a sign of side effects—but in which doctors, despite specializing in skin diseases, failed to take sufficient measures to prevent worsening of the symptoms.
In the case of a man in his 60s, he developed symptoms such as skin inflammation immediately after he began taking the medicine, and the symptoms initially disappeared. But he redeveloped the symptoms on the 50th day after starting to take the medicine, and his condition got worse and worse. Finally, he died due to sores all over his body.
The committee decided it was possible that his doctor had overlooked signs of side effects from the medicine.
Clinical tests have found that side effects of the medicine can be prevented from worsening if doctors monitor skin conditions carefully. Thus the ministry limited authorization to prescribe the medicine to about 800 medical institutions with doctors that specialize in liver and skin diseases.
According to the company, there were problems aside from the fatalities. For example, there were cases in which patients who took the medicine developed skin symptoms—a sign of side effects—but in which doctors, despite specializing in skin diseases, failed to take sufficient measures to prevent worsening of the symptoms.
http://the-japan-news.com/news/article/0001453154
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