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CareMed selected to distribute Tarceva

BY Alaric DeArment

LAKE SUCCESS, N.Y. — Specialty pharmacy CareMed Pharmaceutical Services has been added to a limited-distribution network for a cancer drug sold by Genentech and Astellas Pharma, the company said.

CareMed said it had been selected to supply the drug, Tarceva (erlotinib). The two drug makers stopped distributing the drug, a once-daily treatment for advanced lung cancer, through retail pharmacies at the beginning of July.

"CareMed is honored to be able to continue supplying our patients with Tarceva," CareMed SVP sales and marketing John Witkowski said. "In 2013, the American Cancer Society estimates 228,000 Americans will be diagnosed with lung cancer, with [non-small cell lung cancer] accounting for 85% of lung cancer cases. Of these, the majority of people diagnosed will already be in an advanced stage of the disease."

 

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CHPA files citizen petition to allow liquid APAP dosing recommendations for children 6 months to 2 years

BY Michael Johnsen

WASHINGTON — The Consumer Healthcare Products Association on Monday asked the Food and Drug Administration to take action to ensure that the millions of caretakers who use acetaminophen products in young children have access to convenient and accurate dosing information. Representing makers of over-the-counter single-ingredient liquid acetaminophen medicines for children, CHPA submitted a citizen petition requesting that the FDA publish a “statement of enforcement policy” permitting manufacturers of OTC single-ingredient liquid pediatric acetaminophen products to include dosing information for children ages 6 months to 2 years on the Drug Facts label of these medicines.  

While acetaminophen is approved for use in young children, the currently allowed labeling under tentative final monograph includes only “ask a doctor” in the dosing directions for children ages 6 months to 2 years. 

“The peak of acetaminophen usage in children is for those ages 6 months to 23 months, yet the labeling of these products lacks instructions for this population,” stated Barbara Kochanowski, CHPA VP of regulatory and scientific affairs. “Young children can spike a fever at any time of the day or night, and to get dosing information for children under 2, caretakers must proactively seek out information from a healthcare provider rather than having the convenience of instructions printed on the Drug Facts label," she said. “Providing clear, consistent instructions directly on the label will help ensure that caretakers appropriately dose children under 2 years of age, potentially reducing the likelihood of dosing errors and dosing ‘guesses’ in the middle of the night.” 

In its citizen petition, CHPA requested permission for manufacturers to include pediatric dosing for children ages 6 months to 2 years on product labels moving forward, while rulemaking around the monograph is finalized. CHPA recommended a single, standardized age and weight-based chart — based on the researched and established dosing recommendations of multiple pediatric and primary care medical association treatment guidelines — which all manufacturers could adopt.

In May 2011, a joint FDA Pediatric Advisory Committee and Nonprescription Drugs Advisory Committee unanimously recommended that OTC single-ingredient liquid pediatric acetaminophen products include dosing information for children ages 6 months to 2 years.


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CRN publishes commentary criticizing latest omega-3 research in Natural Medicine Journal

BY Michael Johnsen

WASHINGTON — The limitations within a recent study linking omega-3 fish oil and increased prostate cancer risk ought to be taken in consideration, according to a commentary published in the August issue of Natural Medicine Journal

Published July 11 in the online edition of the Journal of the National Cancer Institute, the report in question suggested that high concentrations of EPA, DPA and DHA — the three anti-inflammatory and metabolically related fatty acids derived from fatty fish and fish-oil supplements — are associated with a 71% increased risk of high-grade prostate cancer. The study also found a 44% increase in the risk of low-grade prostate cancer and an overall 43% increase in risk for all prostate cancers.

According to co-authors Duffy MacKay, the Council for Responsible Nutrition’s VP scientific and regulatory affairs, and Barry Ritz, CRN senior scientific advisory council vice chair, the study was an epidemiological study — meant to generate a hypothesis, not establish a cause-and-effect relationship. However, the study’s researchers intended to look at the relation between selenium and vitamin E supplementation on prostate cancer risk. At no point during the study were the subjects given fish or fish oil supplements. Also, dietary intake of fish or fish oil supplements was not documented, creating no data to back the conclusion that supplemental omega-3 fats are correlated to an increase risk of prostate cancer.

Additionally, MacKay and Ritz noted that the conclusion of the study contradicts the recommendations of reputable health organizations as well as the greater body of scientific evidence which demonstrates the established benefits of both fish and fish oil, saying this study “should not change clinicians’ dietary recommendations or prescribing patterns.”

“With nearly a fifth of all U.S. adults taking omega-3 fish oil supplements each year, it’s not only essential to counter balance the consumer headlines that often make sweeping conclusions,” MacKay said. "But it’s equally important to engage the scientific and clinician communities in a dialogue so that the science is critically interpreted. Part of our role at CRN is to make sure the science is interpreted fairly.”


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