FDA Approves Name Change for Heartburn Drug Kapidex

The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.

Since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex (bicalutamide) and Kadian (morphine sulfate), which have very different uses from Kapidex and from each other.

Kapidex is a proton pump inhibitor used to treat heartburn and other conditions by reducing the amount of acid produced in the stomach. Casodex, marketed by AstraZeneca, is used to treat men with advanced prostate cancer. Kadian, distributed by Actavis Kadian LLC, is an opioid analgesic used to treat pain.

“The FDA is pleased to have worked with Takeda to take swift and responsible steps to change the name of this product in the interest of patient safety,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The FDA evaluates new drug names before a product is approved to minimize confusion with existing drugs. Sometimes unexpected name confusions can occur once the product goes to market.

To improve this safety process, the FDA has issued a new guidance for industry titled Contents of a Complete Submission for the Evaluation of Proprietary Names. The guidance explains what information should be submitted to help in the evaluation of a proposed proprietary drug or biologic name, and to ensure compliance with other requirements for labeling and promotion.

These efforts are part of the agency’s Safe Use Initiative which was launched in November 2009. The goal of this initiative is to reduce preventable medical errors through collaboration with public and private institutions.

There will be no changes made to Kapidex other than its name. Health care professionals and other individuals responsible for ordering, stocking, and billing for the product should be aware that Dexilant will have a new National Drug Code (NDC) number associated with the product.

Individuals and health care professionals who have questions about the name change should contact Takeda at 877-TAKEDA-7.

Medication errors involving Dexilant or any other medications should be reported to the FDA’s MedWatch program online at http://www.fda.gov/medwatch1.

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New Study Shows That American Public is Willing to Accept Major Reforms in Medicare Program

/PRNewswire/ -- Although Americans see Medicare as a key part of the country's social contract and want to preserve it in some recognizable form, they are willing to consider significant changes in the program to hold down its costs as the U.S. population ages.

In day-long "Choice-Dialogues" in which Americans from all walks of life considered the pros and cons of a range of choices for reforming Medicare, common ground was found in several key areas:

-- Allow Medicare to negotiate prices for prescription drugs (94 percent
support).
-- Encourage hospice care instead of heroic end-of-life measures (85
percent support).
-- Only cover treatments that are scientifically proven to be effective
(68 percent support).
-- Emphasize preventive care and personal responsibility (89 percent
consider preventive care very important or essential).
-- Gradually increase the Medicare eligibility age from 65 to 67 (68
percent support).


If additional money is needed to maintain Medicare in a way that is familiar in the future, Americans would rather see the government raise taxes than increase the federal debt.

These are among the central findings in a report released today by The Concord Coalition and Viewpoint Learning, Inc. The report is entitled "Medicare: It's Not Just Another Program."

The report, which was written by Viewpoint Learning, also underscores public dismay at the health care system in general. It comes as Congress and the Obama administration are working on massive changes in the entire system.

"Participants repeatedly expressed concerns over what they saw as a Byzantine and unaccountable health care system," the Medicare report says. "Most felt that the medical industry (especially the pharmaceutical companies) puts profits before people."

Robert L. Bixby, executive director of The Concord Coalition, says the report shows that Americans are prepared to accept significant changes in the program that plays a central role in the federal government's long-term fiscal problems.

"Medicare is on an unsustainable path and must be reformed," Bixby said. "According to conventional wisdom, however, the public is not ready to accept any change in the status quo. The good news from these Choice-Dialogues is that the conventional wisdom is wrong; the public is ready and willing to consider some very fundamental Medicare reforms so long as the program is preserved as a vital part of the social contract."

"Politicians who are truly interested in saving Medicare should stop the scare tactics and start engaging the public in a dialogue on the real trade-offs that must be confronted," Bixby added. "Changes will still be difficult, but the results will be more acceptable."

Viewpoint Learning conducted the dialogues with randomly selected representative samples of 35-40 citizens in Oak Brook, Illinois; Columbia Maryland; Phoenix and Houston. This project builds on the findings of a broader two-year project, "The America We Want," that examined public opinion on a broader range of federal programs and budget issues.

The new report found that many Americans lacked a strong understanding of the Medicare program, how it is funded, and the severity of the fiscal challenges facing the United States in the years ahead.

Yet most participants in the dialogues, after studying these issues in depth and spending much of a day discussing the problems and possible solutions with others, were able to agree on a set of Medicare changes.

But to win public support, the report cautions, "proposals for major reform to Medicare need to recognize the extent to which Americans see Medicare as an essential part of the social contract and not just as another government program."

Steven Rosell, president of Viewpoint Learning, said "The findings from these daylong dialogues with Americans from very different backgrounds and perspectives reveal deep disconnects between how Washington talks about Medicare and health care reform and how the public talks about them. In case after case, the report shows how leaders and the public are talking past each other, and how this deep disconnect and misunderstanding lead to the heat and the rancor that have made advancing real reform so difficult."

When most people talk about the "cost of health care," for example, they are focused on what they pay in premiums, co-pays and drug expenses. When health care experts talk about costs, however, they usually focus on the costs to businesses, government and other institutions.

Rosell also noted that many Americans do not realize that they are essentially paying for the cost of care for the uninsured already.

The new report, he said, provides insight for leaders about how best to bridge such disconnects and begin to create a learning curve that could lead to public support for significant Medicare reform.

Some elements in the new report also echo the findings of The Concord Coalition's fiscal advisory councils that met in early December in Washington. Working in six different parts of the country on Concord's Fiscal Stewardship Project, these advisory councils called for sweeping reforms in the health care system and some changes in Medicare to put the government on a more sustainable fiscal path. More information on the advisory councils' work is available at:

http://concordcoalition.org/fiscal-stewardship-project/fiscal-stewardship- project.

The full report, entitled "Medicare: It's Not Just Another Program," is available at: http://www.concordcoalition.org/files/uploaded-pdfs/Medicare_Report_Dec09_PRIN T.pdf

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FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.

Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over–the–counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

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Massive Cuts to Medicare Home Oxygen Therapy Benefit Taking Effect January 1 Creating Acute Anxiety Among Beneficiary and Provider Communities

/PRNewswire-USNewswire/ -- As Americans nationwide prepare to celebrate the New Year, the home oxygen community is looking to 2009 with great unease due to significant Medicare policy changes that will present many challenges to beneficiaries and providers alike. On January 1, two new policies in the form of a 36-month cap on payments for home oxygen therapy and a 9.5 percent across-the-board payment cut will take effect, deeply impacting a community that cares for more than 1.5 million elderly and chronically ill patients.

Under the new 36-month cap, Medicare will stop payment for stationary home oxygen therapy equipment and related services after the beneficiary reaches the three year mark. Despite the discontinuation of payments after 36 months, providers will still be required to continue all servicing of patient needs and equipment including patient-generated, non-routine emergency home visits and routine replacement of disposable oxygen supplies, such as tubing and masks. Providers will also be responsible for ensuring that patients are appropriately serviced even if the patient moves out of the provider's service area within or following the first 36 months of service.

"The provider community is extremely committed to making every effort to meet patient needs and provide uninterrupted services," said Peter Kelly, Chairman of the Council for Quality Respiratory Care (CQRC). "However, it is difficult to comprehend how providers can maintain patient service levels on an uncompensated basis. Based on the magnitude of these cuts, the provider community cautions that service reductions may be unavoidable as a result of business failures or financial hardship and cause potential access problems for the vulnerable patient population we care for."

Historically, the home oxygen benefit has been subject to repeated cuts. The implementation of the 36-month cap, enacted by Congress in the Deficit Reduction Act of 2005 (DRA), and the 9.5 percent cut, part of the Medicare Improvements for Patients and Provider Act of 2008 (MIPPA), translate to a 27 percent, or $845 million, cut in 2009 alone. A recent analysis from Avalere Health "indicates that the average Medicare home oxygen payment by 2009 will be less than half of what it was in 1997."

The CQRC urges Centers for Medicare and Medicaid Services (CMS) officials to exercise the Secretary's authority to create reasonable post-cap policies, including payments for emergency and non-routine services and reimbursement for disposable supplies after 36 months. CMS should also reset the cap when a beneficiary moves out of his or her service area and requires a new provider. The CQRC asks policymakers to closely monitor the effects of these deep cuts on both beneficiaries and providers to ensure that patient access to essential home oxygen care is not compromised. Ultimately, the home oxygen community hopes to work with policymakers to develop thoughtful, comprehensive reforms of Medicare policies that protect patient access to quality oxygen care.

"We want all patients to have complete access to all services related to their home oxygen care, throughout their entire period of medical need," added Kelly. "With more than one quarter of home oxygen beneficiaries requiring oxygen for more than 36-months, the impact of the cap, coupled with the dramatic 9.5 percent cut, is going to resonate throughout the oxygen community. Although providers are working hard to prepare for the approaching payment changes, these cuts are simply unsustainable and may negatively impact beneficiary care."

The Council for Quality Respiratory Care is an alliance of the nation's leading home oxygen therapy providers and manufacturers, representing nearly one half of the 1.5 million Medicare beneficiaries who depend on the home oxygen benefit for independence and quality of life.

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FDA Approves Updated Labeling for Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

"As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks."

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug's use.

One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Raptiva was approved in 2003. It is manufactured by Genentech, Inc. of San Francisco, Calif.

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