News Briefs: Week of Jan. 10-14

January 12, 2011 05:20 pm News Staff

This roundup includes the following news briefs:

Weight Loss Products Removed From Market

PRock Marketing LLC is recalling all lots of Fruta Planta and Reduce Weight Fruta Planta after the FDA determined that the products contain sibutramine, which was withdrawn from the market in December for safety reasons.

The FDA said in a Dec. 31 news release(www.fda.gov) that it has received multiple reports of adverse events associated with the use of the products, including several cardiac events and one death.

The agency said consumers should stop using the products immediately and added that consumers who have experienced any negative side effects should consult a physician as soon as possible. Sibutramine may increase blood pressure and/or pulse rate in some patients and may present a serious risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke, the FDA said.

Physicians and patients should report adverse events or side effects related to the use of these products to the FDA's MedWatch program(www.fda.gov).

Metronidazole Tablets Recalled

Teva Pharmaceuticals is recalling one lot of its 250-mg metronidazole tablets because of the presence of underweight tablets that may not contain the full amount of the active ingredient, which could prevent patients from receiving their prescribed dose.

"This may cause the infection the drug was intended to treat to worsen or recur, which could be life-threatening when treating severe infections," the FDA said in a Jan. 6 safety alert(www.fda.gov).

Metronidazole is indicated for the treatment of symptomatic trichomoniasis in males and females and asymptomatic trichomoniasis in females when the infection is associated with certain cervical conditions. The drug also is indicated for treatment of asymptomatic consorts of patients with Trichomonas vaginalis infection, as well as for patients with amebiasis and a variety of anaerobic bacterial infections, the FDA said.

The agency said consumers who have product from recalled lot No. 312566 should stop using the antibiotic and return it to their pharmacy. Physicians and patients should report adverse events or side effects related to the use of the products to the FDA's MedWatch program(www.fda.gov).

GSK Updates Prescribing Information for Asthma Drug

GlaxoSmithKline is notifying physicians(www.gsksource.com) about safety information for its asthma medication salmeterol xinafoate inhalation powder, which is marketed as Serevent Diskus.

The FDA announced in February 2010 that it would require new warnings for long-acting beta agonists, or LABAs, that state the drugs should never be used alone to treat asthma in children or adults but may be used in combination with another asthma controller medication.

GSK said in its letter to physicians that the prescribing information for salmeterol xinafoate includes a boxed warning to highlight the risk of asthma-related death. The manufacturer's letter also emphasizes the following new prescribing guidelines:

  • Salmeterol xinafoate inhalation powder should only be used as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, or ICS, in patients ages 4 years and older with reversible obstructive airway disease.
  • Use of the medication for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an ICS, is contraindicated.
  • Use salmeterol xinafoate only as additional therapy for patients with asthma who currently are taking but are inadequately controlled on a long-term asthma control medication, such as an ICS.
  • After asthma control is achieved and maintained, assess the patient at regular intervals, step down therapy if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an ICS.
  • Do not use salmeterol xinafoate for patients whose asthma is adequately controlled on low- or medium-dose ICS.
  • For pediatric and adolescent patients with asthma who require the addition of an LABA to an ICS, a fixed-dose combination product containing both an ICS and an LABA should be used to ensure adherence to both drugs. In cases where use of a separate long-term asthma control medication and an LABA is indicated, steps must be taken to ensure adherence with both medications. If adherence cannot be assured, a fixed-dose combination product containing both an ICS and an LABA is recommended.

GSK said physicians prescribing salmeterol xinafoate inhalation powder should discuss the benefits and risks of LABAs with their patients and encourage those who are prescribed the drug to thoroughly review its medication guide prior to using.

New Year Signals Start of Key Health Care Reform Provisions

Jan. 1 marked the start of a new year, but it also signaled the enactment of several provisions in the Patient Protection and Affordable Care Act, including a measure to pay a 10 percent bonus to primary care physicians whose primary care services comprise at least 60 percent of their total Medicare services. The 10 percent Medicare bonus will be in effect from 2011 through the end of 2015.

The health care reform law also calls for eliminating financial barriers for many preventive services under the Medicare and Medicaid programs. By law, Medicare and Medicare were required to eliminate copays, deductibles and coinsurance amounts for preventive services rated "A" or "B" by the U.S. Preventive Services Task Force starting on Jan. 1. Medicare beneficiaries also are entitled to a free annual "wellness exam" from physicians who are required to establish a personalized prevention plan for them, another provision that took effect on Jan. 1. In addition, the law eliminated any cost-sharing for the "Welcome to Medicare" physical exam as of that date.

Meanwhile, the law prohibits consumers with flexible spending accounts from using the accounts to pay for OTC drugs unless they have a physician's prescription. The provision, which took effect on Jan. 1, applies to health reimbursement arrangements, health savings accounts and Archer medical savings accounts.

Another provision that became effective on Jan. 1 provides relief for Medicare beneficiaries who fall into the prescription drug coverage gap known as the "doughnut hole." Medicare beneficiaries whose total prescription costs for the year fall between $2,840 and $6,448 will receive a 50 percent discount on brand-name medications.

New Publications Explore Workforce Diversity, Aid Students With Disabilities

Detailed statistical information on the demographics and practice patterns of the physician workforce that graduated from U.S. allopathic medical schools between 1978 and 2008 is available in a free publication from the Association of American Medical Colleges, or AAMC.

Diversity in the Physician Workforce: Facts and Figures 2010(members.aamc.org) provides physicians, medical students, faculty, administrators, researchers and policymakers with a compendium of information, including selected data from the U.S. Census Bureau and the Kaiser Family Foundation's StateHealthFacts.org website(www.statehealthfacts.org).

A second AAMC publication aims to provide medical educators with resources to work with students with disabilities. That publication, Medical Students With Disabilities: Resources to Enhance Accessibility(members.aamc.org), presents an up-to-date view of what constitutes a disability at a time when medical schools are accepting and matriculating a growing number of students with a wide range of disabilities.

The AAMC says the publication emphasizes assistive technologies available for medical students.


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