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Friday, September 30, 2011

Primatene Mist, Epinephrine Inhalers For Asthma, Will No Longer Be Available After Dec. 31, 2011


chlorofluorocarbons, or CFCs — the ozone-depleting chemicals that were banned in the late '70s have quietly existed in Asthma inhalers. Even though they were banned in use, CFCs were permitted in medical products such as asthma inhalers which was deemed essential.
But that is also coming to an end as the FDA recently announced that phasing out of asthma inhalers that use CFCs. Epinephrine CFC inhalers, marketed as Primatene Mist, are being phased out because they use CFCs as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. Primatene Mist is also the only Asthma inhaler available over the counter.
With all these in mind, users of Primatene Mist must take appropriate action to replace the medicine in timely manner. They will have to use a prescription medicine to replace Primatene Mist. Due to the demand, Primatene Mist may even be harder to find even before the deadline, follow the links given below to find the best solution.

For more information:

• Phase Out of Epinephrine CFC Metered-Dose Inhalers

• Epinephrine CFC Metered-dose Inhalers - Questions and Answers

• Consumer Update: Primatene Mist with Chlorofluorocarbons No Longer Available After Dec. 31, 2011

FDA Announcement;

FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011
Users of Primatene Mist will need a prescription product to treat their asthma

The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.

Epinephrine inhalers, marketed by Armstrong Pharmaceutical Inc. as Primatene Mist, are the only FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma that are sold over-the-counter in retail stores without a prescription. The product uses CFCs to propel the medicine out of the inhaler so that consumers can breathe it into their lungs.

However, Primatene Mist will no longer be available by year’s end because no CFC-containing epinephrine inhalers can be made or sold after Dec. 31, 2011, to comply with obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. This is an international agreement signed by the United States, in which countries agreed to phase-out substances that deplete the ozone layer, including CFCs, after certain dates.

“If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA began public discussions about the use of CFCs in epinephrine inhalers in January 2006. The FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008. Many manufacturers have changed their inhalers to replace CFCs with an environmentally-friendly propellant called hydrofluoroalkane (HFA). There is currently no HFA version of epinephrine inhalers.

There are, however, many other safe and effective inhalers to treat asthma symptoms. All of these inhalers require a prescription, which must come from a licensed health care professional (physician, physician’s assistant or nurse practitioner). Current epinephrine inhaler users that don’t have a health care professional to write them a new prescription can ask a family member or friend what doctor they use and would recommend, or they can visit a federally-qualified health center, local clinic, community health center, or minute-clinic (sometimes located in pharmacies) to see a health care professional and get a prescription.

Primatene Mist already carries a prominent notice about the phase-out date on its product label, and the FDA encourages Armstrong Pharmaceutical to further educate consumers as the deadline approaches to ensure an incident-free transition. The agency also will continue to work with retailers and pharmacies to facilitate a smooth phase-out of this CFC product and is prepared to review applications for replacement products.

For more information:

• Phase Out of Epinephrine CFC Metered-Dose Inhalers

• Epinephrine CFC Metered-dose Inhalers - Questions and Answers

• Consumer Update: Primatene Mist with Chlorofluorocarbons No Longer Available After Dec. 31, 2011

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Thursday, September 15, 2011

Apixaban May Join Wafarin Combatting Clot For Patients With Atrial Fibrillation.

According to a post on NEJM blog and the release of the primary results of the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial (ARISTOTLE; ClinicalTrials.gov number, NCT00412984) indicate that Apixaban is actually superior to Wafarin.
The trial was to find if Apixaban was non inferior to Wafarin but the trail investigators found that apixaban was actually superior, reducing the risk of stroke or systemic embolism by 21% and the risk of major bleeding by 31%. In predefined hierarchical testing, apixaban, as compared with warfarin, also reduced the risk of death from any cause by 11%.

The Apixaban results follow two other, phase 3 trials that compared new anticoagulants with warfarin in patients with atrial fibrillation:
the Randomized Evaluation of Long-Term Anticoagulation Therapy trial (RE-LY, NCT00262600)(Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-1151[Erratum, N Engl J Med 2010;363:1877.]
Full Text | Medline ) and Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF, NCT00403767)- (Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-891 Full Text  | Medline ). The RE-LY trial evaluated the direct thrombin inhibitor dabigatran in two different doses, 110 mg and 150 mg, both administered twice daily. ROCKET AF evaluated the direct factor Xa inhibitor rivaroxaban at a dose of 20 mg once daily.

The trials have a number of similar conclusions. Apixaban, dabigatran, and rivaroxaban, as compared with warfarin, all significantly reduce the risk of hemorrhagic stroke. In fact, in all the studies, the reductions in the primary efficacy end point — which included hemorrhagic as well as ischemic stroke — were greatly influenced by this dramatic reduction in the risk of hemorrhagic stroke. Of the three drugs, only dabigatran at a dose of 150 mg holds the distinction of also having significantly reduced the risk of ischemic stroke as compared with warfarin; nonetheless, even in this case, there was a greater influence on hemorrhagic stroke than on ischemic cerebrovascular events. Similarly, the risk of particularly serious bleeding was reduced with each of the three drugs, as compared with warfarin, and apixaban therapy also resulted in lower rates of all major bleeding. Thus, the newer anticoagulants boast favorable bleeding profiles as compared with warfarin in patients with atrial fibrillation.
NEJM

Monday, September 12, 2011

IBM's Jeopardy Wiz Watson Goes To Work For WellPoint, A Medical Insurance Company

Pretty soon IBM's Watson technology will be assisting Doctors and others involved in health care how to treat you based on your health history and Watson's huge capacity to comb through data.
The Wall Street Journal reports that IBM's new technology will first be put to use for patient treatment requests by quickly scanning a person's medical history and suggesting the best course of action. In the coming years, Wellpoint hopes to put Watson's immense database at the fingertips of doctors and nurses, providing a valuable ally in disease diagnosis and research.


WellPoint and IBM Announce Agreement to Put Watson to Work in Health Care

INDIANAPOLIS and ARMONK, N.Y., Sept. 12, 2011 /PRNewswire via COMTEX/ -- WellPoint, Inc. (NYSE: WLP), and IBM (NYSE: IBM) announced an agreement today to create the first commercial applications of the IBM Watson technology. Under the agreement, WellPoint will develop and launch Watson-based solutions to help improve patient care through the delivery of up-to-date, evidence-based health care for millions of Americans. IBM will develop the base Watson healthcare technology on which WellPoint's solution will run.

Watson, named after IBM founder Thomas J. Watson, is a computing system built by a team of IBM scientists who set out to accomplish a grand challenge - build a computing system that rivals a human's ability to answer questions posed in natural language with speed, accuracy and confidence. Earlier this year, Watson competed and won against two of the most celebrated players ever to appear on Jeopardy!. This historic match is being rebroadcast over three days, beginning today.

Watson's ability to analyze the meaning and context of human language, and quickly process vast amounts of information to suggest options targeted to a patient's circumstances, can assist decision makers, such as physicians and nurses, in identifying the most likely diagnosis and treatment options for their patients.

In recent years, few areas have advanced as rapidly as health care. For physicians, incorporating hundreds of thousands of articles into practice and applying them to patient care is a significant challenge. Watson can sift through an equivalent of about 1 million books or roughly 200 million pages of data, and analyze this information and provide precise responses in less than three seconds. Using this extraordinary capability WellPoint is expected to enable Watson to allow physicians to easily coordinate medical data programmed into Watson with specified patient factors, to help identify the most likely diagnosis and treatment options in complex cases. Watson is expected to serve as a powerful tool in the physician's decision making process.

Medical conditions such as cancer, diabetes, chronic heart or kidney disease are incredibly intricate. New solutions incorporating Watson are being developed to have the ability to look at massive amounts of medical literature, population health data, and even a patient's health record, in compliance with applicable privacy and security laws, to answer profoundly complex questions. For example, we envision that new applications will allow physicians to use Watson to consult patient medical histories, recent test results, recommended treatment protocols and the latest research findings loaded into Watson to discuss the best and most effective courses of treatment with their patients.

"There are breathtaking advances in medical science and clinical knowledge, however; this clinical information is not always used in the care of patients. Imagine having the ability to take in all the information around a patient's medical care -- symptoms, findings, patient interviews and diagnostic studies. Then, imagine using Watson analytic capabilities to consider all of the prior cases, the state-of-the-art clinical knowledge in the medical literature and clinical best practices to help a physician advance a diagnosis and guide a course of treatment," said Sam Nussbaum, M.D., WellPoint's Chief Medical Officer. "We believe this will be an invaluable resource for our partnering physicians and will dramatically enhance the quality and effectiveness of medical care they deliver to our members."

Watson may help physicians identify treatment options that balance the interactions of various drugs and narrow among a large group of treatment choices, enabling physicians to quickly select the more effective treatment plans for their patients. It is also expected to streamline communication between a patient's physician and their health plan, helping to improve efficiency in clinical review of complex cases. It could even be used to direct patients to the physician in their area with the best success in treating a particular illness.

"With medical information doubling every five years and health care costs increasing, Watson has tremendous potential for applications that improve the efficiency of care and reduce wait times for diagnosis and treatment by enabling clinicians with access to the best clinical data the moment they need it," said Manoj Saxena, general manager, Watson Solutions, IBM Software Group. "WellPoint's commitment to innovation and their work to improve how care is delivered and benefits administered make them an ideal partner for IBM's software and services to pioneer new efficiencies in health care."

Depending on the progress of the development efforts, WellPoint anticipates employing Watson technology in early 2012, working with select physician groups in clinical pilots.

"The implications for health care are extraordinary," said Lori Beer, WellPoint's executive vice president of Enterprise Business Services. "As one of the nation's largest health insurers, we have an important role to play in helping to improve health care quality. We believe new solutions built on the IBM Watson technology will be valuable for our provider partners, and more importantly, give us new tools to help ensure our members are receiving the best possible care."

About WellPoint

WellPoint works to simplify the connection between Health, Care and Value. We help to improve the health of our members and our communities, and provide greater value to our customers and shareholders. WellPoint is the nation's largest health benefits company in terms of medical membership, with 34 million members in its affiliated health plans, and a total of more than 70 million individuals served through its subsidiaries. As an independent licensee of the Blue Cross and Blue Shield Association, WellPoint serves members as the Blue Cross licensee for California; the Blue Cross and Blue Shield licensee for Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri (excluding 30 counties in the Kansas City area), Nevada, New Hampshire, New York (as the Blue Cross Blue Shield licensee in 10 New York City metropolitan and surrounding counties and as the Blue Cross or Blue Cross Blue Shield licensee in selected upstate counties only), Ohio, Virginia (excluding the Northern Virginia suburbs of Washington, D.C.), and Wisconsin. In a majority of these service areas, WellPoint does business as Anthem Blue Cross, Anthem Blue Cross and Blue Shield, Blue Cross and Blue Shield of Georgia, Empire Blue Cross Blue Shield, or Empire Blue Cross (in the New York service areas). WellPoint also serves customers throughout the country as UniCare. Additional information about WellPoint is available at http://www.wellpoint.com/.

About IBM

For more information, please visit http://www.ibmwatson.com./
To join the social discussion about Watson, www.ibm.com/social/watson, include the hashtag #ibmwatson in a tweet.
Follow Watson on Facebook: www.facebook.com/ibmwatson.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This press release contains forward-looking information that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)", "intend", "estimate", "project" and similar expressions are intended to identify forward-looking statements, which generally are not historical in nature. These statements include, but are not limited to, statements regarding plans, objectives and expectations with respect to future operations, products and services. Such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include technical, business, financial, regulatory and/or legal issues that may arise in the development and/or implementation of the proposed WellPoint Watson solution. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by federal securities law, we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in WellPoint's and IBM's SEC reports.

SOURCE: WellPoint, Inc.

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