Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication

Risk of Rare, But Life-Threatening Adverse Events or Death

By Drugs.com

The FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. Recently, three pediatric deaths and one non-fatal but life-threatening case of respiratory depression were documented in the medical literature.

These children (ages two to five) had evidence of an inherited (genetic) ability to convert codeine into life-threatening or fatal amounts of morphine in the body. All children had received doses of codeine that were within the typical dose range.

When codeine is ingested, it is converted to morphine in the liver by an enzyme called cytochrome P450 2D6 (CYP2D6). Some people have DNA variations that make this enzyme more active, causing codeine to be converted to morphine faster and more completely than in other people. These “ultra-rapid metabolizers” are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can result in breathing difficulty, which may be fatal. Taking codeine after tonsillectomy and/or adenoidectomy may increase the risk for breathing problems and death in children who are “ultra-rapid metabolizers.” See the FDA Drug Safety Communication for additional information, including a Data Summary.

Read the entire article here.

Burch Equipment LLC Expands Recall to Include Additional Cantaloupe Shipping Dates and to include Honeydew Melons

By FDA.gov

Burch Equipment LLC, North Carolina, is expanding its recall to include all of this growing season's cantaloupes and honeydew melons that may remain on the market because they may possibly be contaminated with Listeria monocytogenes. There have been no illnesses reported to date.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, infection can cause miscarriages and stillbirths among pregnant women. The incubation period (the length of time between consuming a product and becoming ill) for Listeria monocytogenes can be 1 to 3 weeks, but may be in the range of 3 to 70 days.

The whole cantaloupes are identified by a red label reading Burch Farms referencing PLU # 4319. All cantaloupes involved in the recall were grown by Burch Farms, however some of the cantaloupes may have been identified with a "Cottle Strawberry, Inc." sticker referencing PLU #4319 (note: Cottle Strawberry, Inc. did not grow or process the cantaloupe involved in this recall). Cantaloupes from Burch Farms were shipped in both corrugated boxes (9 cantaloupe per case) and in bulk bins.

Honeydew melons involved in this recall expansion do not bear any identifying stickers and were packed in cartons labeled melons.

Consumers who may have purchased these honeydew melons should contact the store where they purchased their melons, for information about whether those melons are part of this recall.

The cantaloupes and honeydew melons involved in this expanded recall were sold to distributors between June 23rd and July 27th, in the following states: FL, GA, IL, KY, MA, MD, ME, MI, NC, NH, NJ, NY, OH, PA, SC, and VA, VT and WV. The melons may have further been distributed to retail stores, restaurants and food service facilities in other states."

Burch Equipment LLC is requesting any consumer that may have one of these cantaloupes or honeydews to discard the product.

There have been no illnesses reported to date. FDA and the North Carolina Department of Agriculture and Consumer Services are working with Burch Equipment LLC following a random sample of a cantaloupe testing positive for Listeria monocytogenes.

This recall expansion is based on FDA's finding of Listeria monocytogenes on a honeydew melon grown and packed by Burch.

Questions can be directed to Burch Equipment LLC at 910-267-5781 Monday through Friday, (9:00am to 4:00pm) or email burch@intrstar.net.

Link to article here.

California Firm Recalls BBQ Chicken Salads for Possible Listeria Monocytogenes Contamination

By FoodSafety.gov

Huxtable's Kitchen, a Vernon, Calif. establishment, is recalling approximately 5,610 pounds of barbeque chicken salads. The salads contain diced onions that are the subject of a Food and Drug Administration (FDA) recall due to possible Listeria monocytogenes contamination, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The product subject to recall is:

• 14.5-oz trays of "TRADER JOE'S BBQ CHICKEN SALAD."

The product subject to recall bears the establishment number "P-11079" inside the USDA mark of inspection. Each package also has a sticker with use-by dates through July 30, 2012. The product was produced between July 20, 2012, and July 24, 2012, and was distributed to retail establishments in Arizona, New Mexico, Southern California, Southern Nevada and Texas. When available, the retail distribution list will be posted on FSIS' website at www.fsis.usda.gov/FSIS_Recalls/Open_Federal_Cases/index.asp.

Read the entire article here.

Medications Target Long-Term Weight Control

New drugs are the first approved by the FDA in 13 years

By James Limbach, ConsumerAffairs.com

More than one-third of U.S. adults are obese, and obesity contributes to a number of health conditions, including high blood pressure, type 2 diabetes, and high cholesterol.

To help obese and overweight Americans who have been unsuccessful in getting their weight under control with diet and exercise, the Food and Drug Administration (FDA) has approved two new medications -- the first drugs for long-term weight management that FDA has approved in 13 years.

Life-long meds

Marketed as Belviq and Qsymia, these prescription medications would be taken for the rest of a person’s life. “For many people, obesity is a life-long condition, but we don’t always think of it -- or treat it -- as such,” says Amy Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP).

“Qsymia and Belviq are considered life-long therapies in patients who respond to and tolerate them,” says Egan.

The drugs are meant to be used in conjunction with a balanced diet and exercise, says Mary Roberts, M.D., a medical officer in DMEP. “These drugs are another tool to be used by someone trying to reach and stay at a healthy weight,” she says.

Read the entire article here.

FDA warns consumers not to eat shellfish from Oyster Bay Harbor, Nassau County, NY

By FDA.gov

The U.S. Food and Drug Administration is warning consumers not to eat raw or partially cooked oysters and clams (shellfish) with tags listing Oyster Bay Harbor, in Nassau County, N.Y., as the harvest area, following illnesses reported in several states caused by vibrio parahaemolyticus bacteria.

Shellfish harvested from Oyster Bay Harbor have been linked to confirmed and possible cases of vibrio parahaemolyticus illness.

Ill persons reported consumption of raw or partially cooked shellfish from the affected area.

The New York state Department of Environmental Conservation (DEC) closed Oyster Bay Harbor, on July 13 to shellfish harvesting.

All shellfish harvesters, shippers, re-shippers, processors, restaurants, and retail food establishments are advised to check the identity tags on all containers of shellfish in their inventories. If the tag indicates the harvest area was Oyster Bay Harbor and a harvest date on or after June 1, 2012, the product should be disposed of and not be sold or served.

Read the entire article here.

Recall: On Winn-Dixie Brand Cheeseburger Macaroni Skillet Dinner

By FoodSafety.gov

Winn-Dixie today announced an immediate Class II voluntary recall of Winn-Dixie Cheeseburger Macaroni Skillet Dinners sold in the 5.8 oz. package with a UPC code of 2114018080, and a sell-by date of May 14, 2013. According to the Food & Drug Administration (FDA), the reason for the recall is the potential for the product to contain small metal fragments.

BI-LO Issues Class II Recall On Southern Home Brand Bacon Ranch Salad Mix & Creamy Parmesan Salad Mix

Today BI-LO announced an immediate Class II voluntary recall of two store brand products, the Southern Home Bacon Ranch Salad Mix and the Southern Home Creamy Parmesan Salad Mix. According to the Food & Drug Administration (FDA), the reason for the recall is the potential for the product to contain small metal fragments.

Experts Warn About Electronic Cigarettes

E-cigarettes could increase nicotine addiction

By James Limbach, ConsumerAffairs.com

A laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze, according to the Food and Drug Administration.

Electronic cigarettes, also called "e-cigarettes," are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. Additionally, they do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

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~Sandy G.