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Avandia could remain available following FDA advisory committee vote

BY Alaric DeArment

PHILADELPHIA — A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

The drug maker said that in a vote on the drug Avandia (rosiglitazone), a majority of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee members — 13 and seven, respectively — voted to modify or remove the drug’s safety protocol, known as a risk evaluation and mitigation strategy, or REMS. REMS are used for drugs that are approved by the FDA but may pose a safety risk to patients. Five members voted to keep the REMS, while one voted to remove Avandia from the market.

The vote was based on a reevaluation of GSK’s 2009 RECORD study, and the FDA will take it into consideration when it decides whether or not to maintain the current safety protocol for Avandia, which will continue to be available through the REMS program. The second analysis of the RECORD study indicated Avandia may not carry higher risk of heart attacks than other diabetes medications.

"We appreciate the committee’s thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendations of the committee," GSK chief medical officer James Shannon said. "We continue to believe that Avandia is a safe and effective treatment option for Type 2 diabetes when used for the appropriate patient and in accordance with labeling."

The controversy surrounding Avandia goes back to 2010, when the FDA moved to significantly restrict access to the drug — once a top-selling Type 2 diabetes drug on the market — in response to a 2007 study suggesting its use could increase the risk of heart attacks and strokes. The drug was made available only to patients if they could not control their blood-sugar levels with Takeda’s Actos (pioglitazone), a drug that belongs to the same class as Avandia. Meanwhile, regulators in the European Union banned the drug altogether.

In January 2011, GSK took a legal charge of $3.4 billion related to an investigation by the U.S. Attorney’s Office for the District of Colorado alleging that it continued selling and promoting the drug in spite of reports of its cardiovascular risks, and the drug’s labeling was revised a month later. In November 2011, Avandia was pulled from retail pharmacy shelves and made available only by mail order from specially certified pharmacies.

 

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Study measures efficacy of lice remedies

BY Alaric DeArment

Head lice have long been the scourge of schoolchildren and their families. In the United States, the Centers for Disease Control and Prevention estimates that 6 million to 12 million lice infestations occur each year among children ages 3 to 11 years. Lice can spread quickly through direct contact with the hair of a person who had them — though personal hygiene, cleanliness of the home or school, and sharing of clothing and personal items is not usually the cause. (Lice are less common among African-Americans, which may be because of the shape and width of African-Americans’ hair, according to the CDC.)

If the ease by which they spread isn’t bad enough, there’s also growing concern that lice could become resistant to over-the-counter medicines used to kill them. A recent study, funded by skin treatments maker Tec Labs and published in the journal Pharmacology & Pharmacy, compared two treatments for head lice: sodium chloride spray in the 1% strength and the current, recommended treatment 1% permethrin crème rinse. 

Though the brand has been on the market for 15 years, “this is the first clinical trial we’ve done on any Licefreee-branded product,” a Tec Labs spokesman told DSN Collaborative Care. Tec Labs markets sodium chloride 1% under the brand name Licefreee Spray, and also markets the treatment in gel and shampoo forms.

The study enrolled 42 treatment subjects, ages 4 years and older, who were diagnosed as having an active head lice infestation, defined as having at least 10 live lice found during a screening. They were then divided into two groups of 21, one of which received sodium chloride spray, while the other received permethrin. Treatment was administered over a course of 15 days, with administration on the first and eighth days and checkups on the first, eighth and 15th days. Only those found with live lice using the same products and protocols as on the first day were given a second administration on the eighth day.

 

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Arizona partners with NBA legend Shaquille O’Neal for new soda line

BY Jason Owen

CHICAGO — Arizona Beverages has teamed up with former NBA All-Star and champion Shaquille O’Neal to launch an all-natural cream soda line. Soda Shaq has hit the market in Arizona’s single-serve 23.5oz. can from Rexam.

Soda Shaq contains real vanilla from Madagascar, is sweetened with pure cane sugar and has just 90 calories per serving. Like all Arizona products, it is made with no artificial colors or preservatives and is available in Original Vanilla Cream, Orange Cream, Blueberry Cream and Strawberry Cream flavors.

"We are excited to expand our offerings to include a great carbonated beverage innovation based on a soda shop classic," said Don Vultaggio, chairman of Arizona Beverages. "With nearly a third less calories than the competition, Soda Shaq’s great-tasting and all-natural cream sodas are perfect for consumers looking for variety. And through our continued partnership with Rexam, we are bringing them to market in another great version of our iconic big cans."

The new can designs include the tagline "A Big Can for the Big Man" and prominently feature O’Neal’s likeness.

Rich Grimley, president and CEO, Rexam BCNA, says, "As the industry leader in 24oz. ‘big’ can production, we continue to grow our relationship with Arizona Beverages, supporting this brand extension with an ideal packaging choice that delivers superior recycling and environmental benefits as well as filling and distribution economics."

Soda Shaq is currently available at retailers nationwide at a suggested retail price of $.99 per can. For more information on this or any other Arizona product, please visit www.drinkarizona.com.


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