Alli 60 mg capsules: Counterfeit Product, UPDATE

There has been an update of the Alli 60 mg. capsules from the January 21 blog post. As of January 23, 2010 the FDA has been updated with information on laboratory analysis of the sibutramine levels in counterfeit product.

A series of additional FDA laboratory tests on the counterfeit product show that cosumers may be taking 3-times the usual daily dose (or twice the recommended maximum dose) of sibutramine when following the dosing directions suggested by Alli.

Healthy people who take this much sibutramine can experience anxiety, nausea, heart palpitations, tachycardia (a racing heart), insomnia, and small increases in blood pressure. This excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease, and can lead to elevated blood pressure, stroke, or heart attack.

Read the MedWatch 2010 Safety summary including:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm

For More Information, please call 1-877 MESSALAW

Toyota Announces Recall For 2.3 Million Vehicles To Fix Accelerator Pedal

Toyota announced another recall, spanning some 2.3 million cars for problems with sticking accelerator pedals.

The recall includes the 2009-2010 RAV4, the 2009-2010 Corolla, the 2009-2010 Matrix, the 2005-2010 Avalon, the 2007-2010 Camry, the 2010 Highlander, the 2007-2010 Tundra and the 2008-2010 Sequioia.

Toyota noted that the recall does not include the Prius or any of the Lexus or Scion brands, which use a pedal system from a different manufacturer.

The company was quick to note that this is actually a separate recall from the late 2009 recall involving 4.3 million vehicles for incorrect floor mats.

The condition is rare, but can occur when the pedal mechanism becomes worn and, in certain conditions, the accelerator pedal may become harder to depress, slower to return or, in the worst case, stuck in a partially depressed position.

Toyota noted that the remedy and timing of the fix isn't apparent yet. Today's announcement is a notice that they will bring a recall, not the actual recall filing itself.

Besides issuing a voluntary recall on affected vehicles, Toyota also offered some advice that can be used here as well, if you happen to find yourself in a situation where your gas pedal becomes stuck while depressed.

If the accelerator pedal sticks in a partially open throttle position or returns slowly to idle position, the vehicle can be controlled with firm and steady application of the brakes. Don't pump the brakes because it could deplete the vacuum assist. That would make it even harder to depress the brake pedal. The brakes will stop the vehicle no matter the throttle position. When under control, the vehicle should be driven to the nearest safe location and the engine should be turned off. Contact a Toyota dealer as soon as possible for assistance.

Alli 60 mg. Capsules, Counterfeit Product

The FDA notified consumes and healthcare professionals about a counterfeit and dangerous version of Alli 60 mg capsules (120 count refill kit). The counterfeit version contains the controlled substance sibutramine which was substituted for orlistat, the active ingredient. GSK has determined that this version of Alli has been sold via the internet, there is no evidence that the product has been sold through other channels such as retail stores.

The differences between the two products can be described in the text and photos in the FDA’s news release. Consumers who believe they have received counterfeit Alli should contact the FDA’s Office of criminal Investigations by calling 800-551-3989 or by visiting the OCI website (http://www.fda.gov/OCI).

For more information please call 1-877 MESSALAW

One Million Graco Strollers are Recalled after Amputations of Kids’ Fingertips

After two months of Graco Children’s Products recalling certain models of the Passage, Alano, and Spreee Strollers due to young children’s fingers being lopped off, 1.5 million strollers are being recalled for related reasons.

A total of five children had their finger tips cut off due to whenever the stroller’s canopy would be opened or closed reports the U.S. Consumer Product Safety Commission. Parents who do own the strollers have been informed to not use the strollers until they have received a repair kit from Gracco. Also it is suggested to visit the Gracco site to view the two types of hinges used on the strollers. Those with a plastic joined hinge with an indented canopy positioning notches are subject to this recall.

Similarily, the company Maclaren recalled their strollers in November 2009 after finger tip amputations in the hinges when opening and closing the stroller.

For more information please call 1-877 MESSALAW.

Dorel Asia Recalls Cribs; 1 Infant Death Reported

About 635,000 cribs are being recalled because of a strangulation hazard that resulted in an Iowa baby being killed, a U.S. watchdog agency said Tuesday.


The U.S. Consumer Product Safety Commission announced on its Web site that Dorel Asia SRL of Barbados was voluntarily recalling the cribs to replace drop side and non-drop side cribs. People who bought the cribs are advised to quit using them immediately until replacement kits are obtained and installed.
The cribs, made in China and Vietnam, were sold at Kmart, Sears and Wal-Mart stores nationwide from January 2005 through last month for between $120 and $700 a piece.

The commission said the drop side hardware can fail, causing the side to detach and create a space in which an infant or toddler can become trapped and strangled or suffocated. There also is a danger posed when a slat is damaged, the agency said.

The fatality reported involved a 6-month-old child in Cedar Rapids, Iowa. The parents continued to use the crib after trying to repair it themselves, the agency said.

The commission and Dorel Asia have received reports of 31 drop side incidents. In six cases, children were trapped between the drop side and crib mattress. Three children suffered bruises.

The agency and company also received reports of 36 incidents of slat breakage, including seven reports of bruises and scratches to children and two reports of entrapment that resulted in no injury.

The recall involves models: WM1633; WM1633-0; WM1676BC; WM1676BCR-DC; WM2163; WM2163DC; WM1633-0-DC; GP004B3EGR; GP004B3WGR; GP006BCEGR; GP006BCWGR; DA1615B3; DAKM5132; DASE5005; DASE5009; DA0504KMC-1N; DA0504KMC-1W; DA1614B3; DAKM5152; and DASE5015.

Consumers can go to www.dorel-asia.com to order the free replacement kit.

For more information please call 1-877 MESSALAW.

Cheese Recall Impacts Target, Whole Foods and other stores

Minnesota-based manufacturer Parkers Farm, Inc is recalling several of its products because they may contain Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections. National markets that carry Parker Farm products- including Shop Rite, Path Mark, Wal-Mart, Target, Price Chopper, and Whole Foods- are being affected.

The risk of a healthy adult becoming ill is very small. Short-term symptoms include headache, fever, stiffness nausea, cramping and diarrhea. But the young, frail, elderly and those with compromised immune systems are more susceptible. The bacterium is especially dangerous if eaten by pregnant women as it can cause miscarriages and still births.

According to the CDC, approximately 2,500 people per year become seriously ill with listerosis and of those 500 die. As of this posting, no one has yet come forward claiming to be ill from the tainted products.

The recalled products, which number in the dozens, include peanut butter, bagel spreads, dips, cheeses and salsas. For a complete list of products, please visit the FDA's website.

New Warnings for a Popular Rub-on Pain Reliever

A federal agency has announced new warnings for all products containing diclofenac sodium, including Voltaren Gel, because the medications have been linked to reports of serious liver damage resulting in transplants and deaths.

Voltaren is a non-steroidal anti-inflammatory drug, or NSAID, which is typically prescribed for osteoarthritis pain. Many favor Voltaren Gel over pills because it is thought to be less likely to cause stomach irritation and bleeding, and it has been lauded as a safer pain reliever, particularly for elderly patients.

But after reports of liver toxicity were linked to Voltaren, officials with the U.S. Food and Drug Administration (FDA), are urging doctors to closely monitor levels of liver enzymes called transaminases in patients who use the gel.

Transaminase levels are measured by a blood test, and the FDA recommends testing four to eight weeks after starting the gel.

“Post-marketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation,” according to an FDA statement.

The FDA said borderline or greater elevations in liver injury tests occurred in 15 percent of Voltaren-treated patients, sometimes as early as the first month of use.

“The warning recently announced was a labeling change applied to all products that contain diclofenac, the active ingredient in Voltaren Gel and several oral NSAID products,” according to an FDA spokesperson.

Robert Shaw, MD, a rheumatologist at the Carroll County Arthritis and Osteoporosis Center in Westminster, Md., says physicians have long known to watch for liver damage in people who take diclofenac sodium pills, but that the new warnings make it clear that the gel also carries a risk.

“It’s especially a risk when patients come in and they’re on other medications that affect the liver or kidneys like statins. You’ve got to be aware that the gel can add to the side effect of these medicines,” he adds.

“As rheumatologists, we give methotrexate all the time. If you add the gel on top of that, even though there’s only a slight absorption, it is additive. That’s also true of the over-the-counter anti-inflammatories like Advil, Aleve and especially Tylenol,” Dr. Shaw says. “So I think the take-home message is – yes the gel has fewer side effects than diclofenac pills. But you still need to be ever vigilant to monitor for potential side effects, especially affecting the liver.”