Drug Topics - November 24, 2008 - (Page 5) Professional COMMUNITY PRACTICE Alaina Scott, Senior Editor Deaths from prescription drugs on the rise The number of deaths and serious injuries resulting from prescription drug use reached record levels in the first quarter of this year, with 4,825 deaths and nearly 21,000 injuries, the Institute for Safe Medication Practices group recently reported. The data came from the U.S. Food and Drug Administration’s (FDA) adverse event reporting system (AERS), which made the data public after eliminating information that identified victims. Because the reporting is voluntary, researchers have speculated that fewer than 10 percent of adverse events make it into the system. The Institute for Safe Medication Practices (ISMP) said the numbers represent a nearly threefold increase in deaths from the previous quarter and a 38 percent increase in injuries from last year's quarterly average. The increase in deaths during the first quarter was not dominated by any one drug. Instead, 10 drugs each caused more than 100 deaths, compared with an average of one to three drugs in previous quarters. Among the most dangerous medications were the antismoking drug varenicline, which was linked to 1,001 injuries and 50 deaths in the three-month period ending in March, and the blood thinner heparin, which was associated with 779 injuries and 102 deaths. Varenicline was the subject of a FDA Public Health Alert about psychiatric side effects, said Thomas Moore, ISMP Quarter Watch Director. Varenicline remains a problem, however, according to institute officials. Since the drug — sold in the United States by Pfizer Inc. under the brand name Chantix — was approved in 2006, it has been linked to 3,325 serious injuries and 112 deaths. Some reports were linked to people attempting suicide or causing injury to themselves after using the drug, which can evoke serious psychiatric problems. Others were linked to blackouts, seizures, or loss of consciousness, perhaps tied to sudden disturbances in heart rhythm. A Pfizer statement released following the ISMP report claimed that the large number of reports might be linked to the high level of adverse publicity associated with the drug. It noted also that nicotine withdrawal could cause irritability, depressed mood, and other changes in behavior. “Based on the [the] totality of data, we stand by the efficacy and safety profile of Chantix when used as directed," the statement said. “Chantix labeling accurately reflects its efficacy and safety event reports and clinical trial data.” The ISMP made specific recommendations it its study for addressing the increase in drug-related injuries, Moore said. “We recommend that the FDA and the manufacturer add a prominent warning about accident risks to the patient Medication Guide and prescribing information for doctors,” the report read. The ISMP recommended the warning be similar to the new warnings about psychiatric side effects. “While we commend the federal government for prompt action in banning Varenicline in the most sensitive occupations such as for airline pilots, air controllers, and military missile crews, a broader warning is still needed.” The heparin cases were associated with contaminated lots of the drug imported from China. The FDA has reported 238 deaths linked to the blood thinner since January, but the number dwindled once the problem was recognized and addressed. The case of heparin is an example of the significant safety drug problem that was promptly resolved by the drug manufacturers and the FDA once the issue was detected, the ISMP report said. “It also underlines the importance of the nation’s system for assuring drug product stability and purity. The scale of injury —hundreds of deaths or serious injuries in a short period — underlines the importance of strengthening oversight of drug manufacture abroad.” Many of the other reports were linked to powerful painkillers or narcotics such as oxycodone, fentanyl, morphine, methadone, and hydrocodone, all of which have a high potential for abuse. Acetaminophen and ibuprofen were among the top 10 drugs causing both injuries and deaths. The drugs are often used in suicide attempts because they are accessible. Overdosing or prolonged usage of either of the over-the-counter medications can cause side effects including gastrointestinal damage and heart attacks. LOGO COURTESY OF FDA W W W.D R U GTO P I C S .C O M N OV. 24, 2008 DRUG TOPICS 5 http://WWW.DRUGTOPICS.COM
Table of Contents Feed for the Digital Edition of Drug Topics - November 24, 2008 Drug Topics - November 24, 2008 Contents Advances in Bone Disease Treatment Reported at ACR Gathering APHA Taps New VP, CEO FDA Deaths from Prescription Drugs on the Rise Drug Topics - November 24, 2008 Drug Topics - November 24, 2008 - Contents (Page 1) Drug Topics - November 24, 2008 - Contents (Page 2) Drug Topics - November 24, 2008 - Advances in Bone Disease Treatment Reported at ACR Gathering (Page 3) Drug Topics - November 24, 2008 - APHA Taps New VP, CEO (Page 4) Drug Topics - November 24, 2008 - Deaths from Prescription Drugs on the Rise (Page 5)
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