News in Brief: Week of Aug. 4-8

August 11, 2014 01:30 pm News Staff

This roundup includes the following news briefs:

FDA Downgrades Rosiglitazone's CVD Risk

The FDA has eliminated the restricted distribution requirements of the Rosiglitazone Risk Evaluation and Mitigation Strategy (REMS) Program(www.rosiglitazonerems.com) based on new understanding of cardiovascular risk associated with rosiglitazone-containing medicines.

The FDA set up the training program to inform prescribers of the current state of knowledge concerning the cardiovascular risk of rosiglitazone-containing medicines. The training is based on data from randomized, controlled clinical trials of rosiglitazone versus metformin or sulfonylureas, which found no difference in overall mortality or major adverse cardiovascular events among intervention groups.

The warning and precautions section of the prescribing information(www.gsksource.com) for rosiglitazone maleate (Avandia) and other rosiglitazone-containing medications has been updated accordingly. Those other medications are
rosiglitazone maleate/metformin hydrochloride (Avandamet), rosiglitazone maleate/glimepiride (Avandaryl) and generic versions of rosiglitazone maleate and rosiglitazone maleate/metformin hydrochloride.

Key changes to the REMS program are:

  • Prescribers no longer need to be certified through the Rosiglitazone REMS Program.
  • Patients no longer need to be enrolled in the Rosiglitazone REMS Program in order to receive rosiglitazone-containing medicines.
  • Pharmacies no longer need to be specially certified in order to dispense rosiglitazone-containing medicines.

GlaxoSmithKline Starts Shipping 2014-15 Flu Vaccines to U.S.

GlaxoSmithKline (GSK) announced last month(us.gsk.com) that it had begun shipping its Fluarix Quadrivalent influenza vaccine to U.S. health care professionals. GSK also has received 2014-15 U.S. license approvals for its other flu vaccine formulations: Fluarix, FluLaval and FluLaval Quadrivalent. The manufacturer said it expects to begin shipping FluLaval Quadrivalent and FluLaval (trivalent) in August.

GSK anticipates supplying 28-33 million doses, across all four vaccines, to the United States for the upcoming 2014-15 flu season.

"Consumers today have more options than ever to help protect themselves against the flu," said Deborah Waterhouse, senior vice president and business unit head, U.S. vaccines, in a news release. "Since introducing our own four-strain vaccines last year, we've seen a strong uptake. It's important for consumers to discuss these options with their physicians and get early seasonal protection as the nature and severity of flu seasons can be unpredictable."

FDA Warns Against Powdered Pure Caffeine

The FDA issued a warning(www.fda.gov) on July 21 that stated powdered pure caffeine is being marketed directly to consumers and that health care professionals should recommend to their patients that these products should be avoided. The agency said it is aware of at least one death of a teenager who used the product.

The FDA pointed to powdered pure caffeine sold in bulk bags on the Internet as a particular concern. Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose, said the agency. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.

Parents should be aware that these products may be attractive to young people.

Surgeon General Issues Call to Action to Reduce Skin Cancer

The U.S. Surgeon General announced a call to action(www.surgeongeneral.gov) to address the problem of skin cancer, the most commonly diagnosed cancer in the United States. Among other components, the call to action lists steps that individuals can take to reduce their risk of exposure.

The rates of skin cancer, including melanoma, are increasing in the United States, with nearly 5 million people treated for skin cancer every year. Melanoma is the deadliest form of skin cancer. Each year, more than 63,000 new cases are diagnosed in the United States, and nearly 9,000 people die from the disease.

In related news, the U.S. Preventive Services Task Force (USPSTF) recently posted a final research plan(www.uspreventiveservicestaskforce.org) on screening for skin cancer. Among the questions the USPSTF plans to research include whether screening by a primary care physician or dermatologist can reduce skin cancer, as well as the potential harmful consequences of screening.

Currently, both the AAFP and the USPSTF agree that "the current evidence is insufficient to assess the balance of benefits and harms of using a whole-body skin examination by a primary care clinician or patient skin self-examination for the early detection of cutaneous melanoma, basal cell cancer, or squamous cell skin cancer in the adult general population." Still, physicians are advised to be vigilant for suspicious lesions when examining patients.

Journal Commentary Addresses High-cost Hepatitis C Treatments

A recent commentary(jama.jamanetwork.com) in JAMA: The Journal of the American Medical Association addressed the controversy surrounding the high costs of new hepatitis C virus (HCV) treatments, including the drug sofosbuvir (Sovaldi). Written by CVS Caremark Chief Medical Officer Troyen Brennan, M.D., and Chief Scientific Officer William Shrank, M.D., the commentary suggests that the discussion about HCV treatment to this point has focused inappropriately on price per pill, rather than on total cost to the health care system.

HCV treatment options have increased over the past three years, and cure rates of between 80 percent and 95 percent have been achieved. But these therapies can be costly. For sofosbuvir, for example, patients pay $84,000 for a standard 12-week course of therapy -- about $1,000 per pill.

"Perhaps the controversy about sofosbuvir is really about the increasing total cost of specialty medications, considering both cost and prevalence of treatment targets," the authors said. "While a daily oral medication that costs $1,000 per pill gains attention, the more important issue is the number of people eligible for treatment. Sofosbuvir is not really a per-unit cost outlier, but is a 'total cost' outlier because of its high cost and very large population eligible for treatment -- a beacon for costs of specialty medications generally."

AHRQ Report, Videos, Show How to Implement Clinical Data Support

A new report(healthit.ahrq.gov) from the Agency for Healthcare Research and Quality (AHRQ) titled Findings and Lessons From AHRQ's Clinical Decision Support Demonstration Projects shows how organizations can successfully develop, implement and evaluate the best methods and approaches for incorporating clinical decision support (CDS) into clinical workflows.

The report and accompanying videos show the approaches that two major hospitals took to creating processes and tools for translating clinical knowledge and narrative guidelines into formats that can be used by multiple electronic health record systems and for implementing CDS across a range of care settings.

More information on the CDS initiative is available online from the AHRQ(healthit.ahrq.gov).


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