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News:
FDA Health Advisory For Zelnorm FDA is issuing this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm. Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm. If any of your patients are using this medication please advise them to contact their prescribing physician immediately. For the full FDA advisory please go here: Eicosapentaenoic Acid Reduces Nonfatal Coronary Events in Hypercholesterolemia Consumption of the fish-oil component eicosapentaenoic acid (EPA) lowers rates of unstable angina and nonfatal coronary events in patients with hypercholesterolemia, researchers report in Lancet. In an open-label, industry-sponsored trial, researchers randomized some 19,000 Japanese patients with total cholesterol levels at 6.5 mmol/L (roughly 250 mg/dL) or greater to receive either 1800 mg of EPA A commentary writer calls the results "unexpected," and says that "we must curb our infatuation with downstream risk factors and treatments, and focus on the fundamental risk factors for cardiovascular disease: dietary habits, smoking, and physical activity." (Published in today's Lancet, 3/30/07) Health care providers must apply for a National Provider Identifier (NPI) All health care providers must apply for a National Provider Identifier (NPI). It is required by HIPAA and the deadline to obtain one is May, 2007. Health insurance will also require this number. It is very easy to apply online and it is free of charge. Please go to: https://nppes.cms.hhs.gov to apply online. New House Bill HR-5688 Threatens Acupuncture Scope of Practice July 21, 2006 Greetings AAOM Members and Colleagues: As many of you may know, the AMA House of Delegates adopted Resolution 814 that called for the "Scope of Practice Partnership" to study the qualifications, education and academic requirement of "limited licensure" health care providers and "limited independent practitioners" such as licensed acupuncturists, naturopaths, chiropractors and anyone else besides MDs, DOs, and Dentists. Parallel bills are to be introduced into the state legislatures. This was reviewed in the July '06 Acupuncture Today. Shortly after the AMA adopted this resolution, HR-5688 was introduced in the US Congress, by Mr. SULLIVAN (for himself, Mr. GENE GREEN of Texas, Mr. BASS, Mr. SCHWARZ of Michigan, Mr. BURGESS, Mr. BILIRAKIS, and Mr. SESSIONS). The principal author’s press release is provided. While the AAOM agrees with concerns about ethics and misrepresentation of title, this bill could impede your rights to comprehensively treat our patients. Thus, patients may be prevented from receiving best care. And, minority cultures could be denied a choice of care. The AMA has promoted HR-5688 in the pretext of "health care trust and transparency" to "protect the public." The bill far exceeds preventing non MDs from calling themselves doctors or misrepresenting their training. It may in fact be intended to restrict scopes of practices to narrow margins, based upon lowest common denominator training. It is comparative to the crusade the AMA waged against the chiropractors' in their Committee on Quackery some 30 years ago. In the 30 years that have passed, the AMA is far savvier about what they restrict to prevent a restraint of trade charge being filed. Call to Action The AAOM Board of Directors have convened a task force comprised of our Executive Committee to respond to HR-5688, and to that extent, we are requesting immediate feedback from students, practitioners, OM Associations/Businesses, and Colleges of OM. Based upon the time critical nature of this request, pleased provide a response via the interactive form provided by close of business, Monday, July 24. We will assess the feedback provided in formulating a response with the final position forward to our members and the profession-at-large by Friday, July 28. HR-5688 Feedback Form We will be asking for the following information: Senate Bill 3546, “Dietary Supplement and Nonprescription Drug Consumer Protection Act.” Senate Bill 3546, introduced in the 2nd Session of the 109th US Congress, may be cited as the “Dietary Supplement and Nonprescription Drug Consumer Protection Act.” This Bill will create a serious Adverse Event Reporting mechanism (AER) for nonprescription drugs. The herbal products used and prescribed by AAOM members are currently covered by this bill. The trade groups involved in the herb trade, the AAOM BOD, and the HMC have examined this bill and support the passage of this bill. Please express your support to your U.S. Senator and U.S. Congressional Representative. This bill will place no burden on and have no impact on health care providers and will reflect a proactive stance on the part of vendors of OM herbal products. All responsible parties involved in the commerce and use of nonprescription drugs support a reasonable information gathering device which will chart possible interactions and the tracking of possible public exposure to products that fail to meet appropriate quality control standards. This tracking mechanism, when recording an alleged AER, will include information from the consumer regarding what prescription drugs, alcohol, recreational drugs and additional supplements were taken during the time period reported. This bill will keep reports confidential until such time that there is a consensus reached by the appropriate experts that that the product reported may indeed be considered a hazard to public health. SB 3546 allows OM Professional Associations to demonstrate responsibility in tracking adverse events. It also allows business members, who are also AAOM members to be closely involved in helping to revise this bill. This will be to the benefit of business members and will exclude any affects on health care practitioners. Please join us in supporting this bill. Click on the following link to conveniently send a letter of support. Based upon the contact information provided, the system will automatically direct your email to your designated representative. Feel free to amend the draft letter provided. Thank you for your time, effort and support. Frequent Use of Nonnarcotic Analgesics Associated with Hypertension in Men Near-daily use of nonnarcotic analgesics, including acetaminophen, confers a moderate increase in the risk for developing hypertension, researchers report in the current Archives of Internal Medicine. The study group comprised some 16,000 men with an average age of 65 and no history of hypertension. The were subjects in the Health Professionals Follow-up Study. Participants reported the frequency of their use of acetaminophen, NSAIDS, and aspirin at baseline; on two questionnaires over the subsequent 4 years they also reported whether they'd been diagnosed with hypertension. Compared with nonusers, those who took NSAIDS, aspirin, or acetaminophen 6 or 7 days a week had a The authors say their findings echo others' and "suggest that these agents be used with greater caution." Some Antioxidant Supplements May Increase Mortality, Meta-Analysis Finds Beta carotene, vitamin A, and vitamin E supplements were associated with increased mortality in a large Researchers examined randomized, controlled trials of antioxidants used for primary or secondary disease The authors conclude: "Our results extend previous reviews and guidelines, suggesting that antioxidant FDA to Review Children's Cold and Cough Drugs The Food and Drug Administration will review over-the-counter cold and cough medications for Popular cold and cough remedies can cause cardiac problems when used at higher than recommended doses. Rarely, complications have been noted at standard doses. According to a recent CDC survey, some 1500 children were treated during 2004-2005 for adverse effects related to these drugs, including The Times reports that pediatricians and public health officials filed a petition yesterday asking the agency "We have no data on these agents of what's a safe and effective dose in children," the director of the FDA's office of nonprescription drugs told the newspaper. FDA MedWatch - Dietary Supplements Promoted for Sexual Enhancement may contain undeclared, dangerous ingredients MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA notified healthcare professionals and consumers of a warning not Read the complete MedWatch 2006 Safety summary, including a link to the http://www.fda.gov/medwatch/safety/2006/safety06.htm#enhance Foreign Product Alert - Zhuifeng Tougu Wan Zhuifeng Tougu Wan is a traditional Chinese medicine (intended use unknown) supplied in the form of ball-bearing-type red pills. The pills are packaged in a white opaque plastic bottle with a screw top and a mustard yellow and gold label. Reason for Warning In November 2005, the U.K.'s Medicines and Healthcare Products Regulatory Agency issued an alert on Zhuifeng Tougu Wan because it was found to contain toxic levels of mercury. Foreign Product Alert - Fufang LuHui Jiaonang According to the U.K.'s Medicines and Healthcare Products Regulatory Agency, Fufang LuHui Jiaonang is a traditional Chinese medicine (intended use unknown) supplied in blister packs contained within a blue and cream-coloured carton. Reason for Warning In November 2005 and April 2006, the U.K's Medicines and Healthcare Products Regulatory Agency issued alerts on Fufang LuHui Jiaonang because it was found to contain toxic levels of mercury. Product is roughly 11 per cent mercury.
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