On July 14, 2010, an article in the Wall Street Journal reports that a U.S. Food and Drug Administration panel voted to recommend that GlaxoSmithKline PLC's (GSK) diabetes drug, Avandia, remain on the market despite concerns the product could raise the risk of heart attacks. Most panelists said the product should be subject to additional restrictions or used only if other diabetes drugs don't work, while many voted to allow the product to remain on the market with additional warnings and some sort of restricted distribution plan or additional doctor and patient education. The panel recommendations will be taken into consideration by the FDA, which will make the final decision about whether Avandia stays on the market. While several panel members said they had significant concerns about Avandia's safety, some said existing clinical data isn't strong enough to support removing Read More

The U.S. Consumer Product Safety Commission (CPSC), in cooperation with Tween Brands Inc., on July 14, 2010, announced a voluntary recall of about 137,000 children’s Metal Necklaces, Bracelets and Earrings because the jewelry contains high levels of cadmium. Although there have been no reported injuries, cadmium is toxic if ingested by children and can cause health issues. The jewelry was sold at Justice and Limited Too stores , and online at www.shopjustice.com from November 2008 through February 2010.  Consumers should immediately take the recalled jewelry away from children and stop using recalled products. This recall involves 19 different styles of children's metal necklaces, bracelets and earrings. Styles and shapes of  the jewelry include hearts, heart locks, butterflies, cupcakes, peace signs and crowns. Some jewelry contains the words "Best," "Friends," or "Forever," and/or "BFF." Only style numbers listed below are included Read More

On July 6, 2010, U.S. Consumer Product Safety Commission (CPSC) released a statement urging parents and caregivers to consider safety  precautions before opening windows.  CPSC warns that open windows may seem harmless but “have proven to be sources of injury and death for young children.” CPSC explains that in recent weeks, several children have fallen from windows. CPSC data indicates that on average, about eight deaths occur yearly to children five years or younger while an estimated 3,300 children five and younger are treated each year in U.S. hospital emergency departments.  Hospitalization was required for about 34 percent of these children after falling from a window. These deaths and injuries frequently occur when kids push themselves against window screens or climb onto furniture located next to an open window.  "The deaths and life-altering injuries we have seen here at CPSC Read More

FDA released a statement on July 8, 2010 regarding Qualaquin (quinine sulfate) and the risk of serious hematological reactions . Due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, FDA approved a risk management plan to warn against the use of this drug for such unapproved uses. The risk management plan (REMS) requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS  requires that the manufacturer issue a Dear Health Care Provider Letter warning of the risk of serious and life-threatening hematologic reactions. Qualaquin is the only FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum. Most users are travelers returning from malaria-endemic areas, but Read More

On July 8, 2010 FDA reports that McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling another 21 lots of over-the-counter medicines, including Benadryl, Children’s Tylenol, Tylenol, and Motrin. This action is a follow-up to the product recall that McNeil Consumer Healthcare earlier this year following consumer complaints of a musty or moldy odor. These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same  type of wooden pallet that was tied to the presence of TBA in earlier recalled lots. All lots involved in the recall were produced before the initial January 15, 2010 recall, after which McNeil stopped accepting shipments of materials from its suppliers on that type of pallet. The lots Read More

On July 13, 2010 The U.S. Food and Drug Administration (FDA) announced that it is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat rheumatoid arthritis. FDA is taking this action to highlight the risk of severe liver injury in patients using this drug and inform consumers how this risk may be reduced. FDA previously required a Boxed Warning stating that leflunomide was contraindicated for use by both pregnant women and women of childbearing potential who were not using reliable contraception. The decision to add information on severe liver injury to the Boxed Warning was based on FDA’s review of adverse event reports which identified 49 cases of severe liver injury, including 14 cases of fatal liver failure, between August 2002 and May 2009. In this review, the greatest risk for Read More

A blog article from June 29, 2010, in the LA Times addressed the recent developments with the drug Avandia. It is explained that in the past week, three studies were released about the side effects linked to Avandia (rosiglitazone), and two found a  potentially troubling rate of side effects.  Avandia was approved in 1999, and some studies have linked it to higher rates of certain adverse events. The drug is known to increase the risk of heart failure and bone fractures but newer data suggest it also raises the risk of heart attacks, strokes and death.  In July a Food and Drug Administration advisory committee will meet to explore Avandia's safety. The article also mentions that The American Heart Association released advice for people taking Avandia. The association stresses that patients discuss their options with their physicians, but also warns Read More

On June 30, The U.S. Consumer Product Safety Commission, in cooperation with the Sony Electronics Inc., announced a voluntary recall of select models of Sony VAIO laptop computers. About 233,000 Sony Vaio notebook computers were recalled because they can overheat and pose a burn hazard to consumers. Sony has received 30 reports of units overheating resulting in deformed keyboards and casings, but as of yet no injuries have been reported. These products were sold at Best Buy, Costco, Frys, Amazon.com and Sony Style retail stores and sonystyle.com as well as other electronics retailers and business suppliers nationwide. The recalled computers, which sold for between $800 and $1500, were shipped to consumers and resellers between January 2010 and April 2010. The recalled products are VPCF11 Series and VPCCW2 Series notebook computers. The computers are available in many colors and have “VAIO” Read More

A recent article by Marilynn Marchione, released by the Associated Press, explores the risks of drugs on the market and questions when a drug is too risky to be on the market after drug safety questions arose again this week about the Diabetes drug Avandia. The author cites examples to show that at times the FDA’s actions may seem inconsistent or even confusing. She mentions two drugs tied to heart risk, one which was removed from the market and another wasn’t. She also mentions a drug that was pulled off, then put back on the market. She explains that the Food and Drug Administration has vague guidelines for deciding what to do in these cases. Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, explains "each drug has its own complex story," so comparisons to previous decisions can't be made, adding Read More