Jantoven and other medications that were packaged on the same Upsher-Smith Laboratories packaging line between May and November of 2010 are all being recalled as a precaution after 10 mg Jantoven tablets were found in a bottle labeled 3 mg.

Since warfarin is used to prevent blood clots in many people with cancer, it is critical that you check your medicine to be sure that it isn’t part of the  Upsher-Smith recall.

A complete description of the recalled pills is available on the FDA website including the tablet color and dose.  All recalled Jantoven tablets are scored and imprinted with WFR and the number 832.

Other recalled Upsher-Smith medicines include:

• Amantadine
• Amlodipine
• Androxy
• Baclofen
• Bethanechol
• Oxybutynin

Descriptions of these pills are also on the FDA website.

If you have questions about whether or not your medicine is part of the recall, talk to your doctor or pharmacist.  Do not stop taking any medicine, particularly Jantoven, without discussing it with your doctor.

A mixup in dosages has prompted a recall of Jantoven® Warfarin.  A single bottle was found to contain 10 mg pills, rather than the 3 mg tablets on the label.

Upsher-Smith Laboratories is voluntarily recalling one lot  (lot #284081) of Jantoven® Warfarin Sodium, 3 mg, to protect patients from getting an overdose.

The pills are very different:  The 3 mg tablets are tan and labeled with a 3 below the line, while the 10 mg ones are white with a 10 below the line.  Both have the number 832 on the reverse side.

Anticoagulation therapy needs careful control.  An overdose from taking 10 milligrams of the medicine, rather than the expected 3, could lead to life-threatening bleeding.

If you think that your medication might be mislabeled, call your doctor right away.  Don’t stop taking warfarin without talking to the doctor, but don’t risk taking the wrong dose.

Consumers and pharmacists can call the Upsher-Smith medical information line at 1-888-650-3789 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).

McNeil Consumer Healthcare has voluntarily recalled all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength Plus Gas Softchews, and ROLAIDS® Multi-Symptom Plus Anti-Gas Softchews being sold in the United States and Canada.

Consumers have reported bits foreign material in the Extra Strength Softchews, including metal and woodchips.  While McNeil investigates the problem, they have suspended production of these products and issued a recall.

A press release from McNeil advises consumers:

While the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare advises consumers who have purchased these recalled products to discontinue use.

If you have purchased recalled Rolaids Softchews, you can contact McNeil Consumer Healthcare, either at www.rolaids.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund.

You can find the lot numbers being recalled on the FDA website along with answers to other questions about the recall.  Lot numbers are found on the back or bottom of packages.

As always, if you have medical concerns or questions, get in touch with your doctor.

You should use the FDA Medwatch system to report any serious problems (adverse effects) from using recalled Extra Strength Rolaids Softchews.

The 25 mcg/hour patches may have a fold-over defect that allows active drug to be released faster than intended.  In one lot of the recalled patches, one patch was found leaking gel.  The remaining lots are being voluntarily recalled as a precaution.

Fentanyl is a strong opioid.  The patch releases a measured amount of the drug each hour which is absorbed by skin.  Damaged patches may release too much medicine, potentially causing slowed or stopped breathing that can lead to death.

Caregivers who handle damaged patches and get gel on their own skin are also at risk.

The patches are packed individually in boxes of five.

Actavis warns patients and their caretakers:

Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

Actavis has operators available to help customers, health professionals and consumers with the following information:

• Medical Issue/Adverse Event/Product Questions: 1-877-422-7452 (24 hours/day, 7 days/week)
• Return/Reimbursement Questions:  1-888-896-4562 (24 hours/day, 7 days/week)

You can find the control/lot numbers of the recalled patches on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.  Control/lot numbers and expiration dates are:

Lab tests have confirmed cases of Salmonella enteritidis associated with eating the eggs.

Eggs were packaged under the names Hillandale Farms, Sunny Farms, and Sunny Meadow and distributed in 14 states.  They have the following plant numbers and Julian dates stamped on the end of the carton or on the label:

• P1860 – Julian dates ranging from 099 to 230
• P1663 – Julian dates ranging from 137 to 230

The plant number begins with the letter P and then the number. The Julian date follows the plant number, for example: P1860 230.

Consumers who believe they may have purchased these shell eggs should not eat them but should return them to the store where they were purchased for a full refund. Consumers with questions should contact Hillandale Farms at (866) 262-4208.

Previously the FDA announced an egg recall from Wright County Egg, another Iowa producer.

A full list of recalled products and the lots has been posted on the FDA site.

Consumers have noticed a moldy, musty, or mildew-like smell when opening the medicines that has sometimes been associated with nausea, vomiting, stomach pain or diarrhea.  Effects have been temporary and not serious.

McNeil has traced the odor to small amounts of a chemical called 2,4,6-tribromoanisole (TBA).  TBA results from a breakdown of a chemical that is sometimes applied to wood pallets used to store and transport cases of the over-the-counter drugs.

The health effects of TBA haven’t been well-studied, according to McNeil, but there are no reports in medical literature of serious problems connected with it.  However, the company is continuing to investigate the issue and will no longer use pallets treated with TBA-associated chemicals to ship products.  They have also asked companies who ship supplies to their plants not to use treated pallets.

More information about the product recall is on the McNeil Product Recall website including:

• Full listing of recalled products with pictures of packaging, UPC codes, and lot numbers
• How to return items for refund or replacement
• How to dispose of recalled medicines safely

McNeil tells consumers not to empty unused medicines in the sink, toilet, or storm drain.  If possible, they should be taken to a pharmacy or community “take-back” program.  Otherwise, they should be securely sealed in an unrecognizable container where children or pets do not have access and thrown in household trash.

A link to SMARxTDisposal.Net has more information about safely disposing of unused medicines.  SMARxT recommends combining medicines with kitty litter, coffee grounds, or similar materials to make them less attractive for children or pets to eat.

More information can be obtained by calling McNeil Consumer Healthcare at 888-222-6036.

Briefly

It’s been tested, and it hurts less to rip a bandaid off fast.

NCCN has updated their guidelines for colon and rectal cancer to include testing for BRAF mutations in patients with metastatic colorectal cancer.

FDA announced a recall of some lots of Alka-Seltzer Plus Day and Night Cold Formula, and an aggressive program to manage respiratory infections at the Seattle Cancer Care Alliance has kept patients there from getting H1N1 flu.

• You already knew it — but now a randomized trial proves it.  It hurts less to remove a bandaid fast.  Tested on healthy volunteers in Australia, the average pain score on an 11 point scale for fast removal was 0.92 compared to 1.58 when the medium-sized bandage was removed slowly.  Women had less pain than men (0.91 versus 1.64) but, to be fair, men also had more body hair.  Skill helps.  Pain scores were consistently higher for one of the two researchers removing bandaids.  You can find the study abstract in the December 2009 issue of the Medical Journal of Australia.
• The National Comprehensive Cancer Network (NCCN) has updated their Clinical Practice Guidelines in Oncology™ for Colon Cancer and Rectal Cancer to recommend BRAF testing for patients with metastatic colorectal cancer who do not have KRAS tumor mutations.  A new footnote was added stating that “Patients with a known V600E BRAF mutation appear to be unlikely to benefit from anti-EGFR monoclonal antibodies.” Anti-EGFR treatments include Erbitux® (cetuximab) and Vectibix™ (panitumumab).  A link to the new Version 1.2010 is available.
• The FDA has announced a recall of one lot of Alka-Seltzer Plus® Day & Night Cold Formula Liquid Gels by Bayer Healthcare.  The recalled lot number is 296939L.  There are twenty capsules in each carton, 12 with a day formulation and 8 with nighttime medicine.  The labeling on some blister pack cards is reversed so that day and night formulations are not identified correctly.  The capsules themselves are labeled accurately.  Mixing up the day and night capsules could result in excessive sleepiness.
• An aggressive influenza control program at the Seattle Cancer Care Alliance protected cancer patients with compromised immune systems during spring of 2009 despite an hundred-fold increase in H1N1 virus in the Seattle area.  Patients who come to the outpatient clinic are met by volunteers or licensed practical nurses with hand sanitizer and information about respiratory infections.  Each is quizzed about possible flu symptoms, and patients who might have influenza are either rescheduled or seen in isolation rooms.   Patients who go through the procedure get a sticker, and no one is allowed in the clinic without one. Staff with respiratory symptoms are sent home, and all staff are required to have influenza vaccination.  Sick leave policy is tolerant of respiratory illness.

Finding the best imaging methods to diagnosis and monitor cancer and comparing new colorectal cancer screening technologies to current standards are among recommended priorities for comparative effectiveness research (CER).  The FDA reports new egg safety rules and the recall of a powdered dietary supplement.

Videos of cancer patients are now online discussing the emotional impact of their diagnosis in The Day I Found Out.

Research Reports

• Reduced uptake on FDG/PET after the first chemotherapy treatment may be able to predict how well patients will respond to chemo. In early information from a study of  advanced colorectal cancer patients reported at ASCO 2009, PET scans before initial chemo and  again two weeks later accurately predicted tumor response on later CT scans.   Dr.  Alain Hendlisz said, “Our results show that if tumor metabolism does not respond after 14 days, the patient is not likely to experience tumor shrinkage two or three months later on. Finding this out early on in treatment can help us avoid unnecessary side effects and also allows us to try another type of therapy sooner, if possible, to optimize results for our patients.”
• Chemotherapy before surgery to remove colorectal cancer that has spread to the liver makes CT scan evaluation less accurate. Doctors in France compared whether liver metastases were correctly identified in 92 patients, 30 of whom did not have chemotherapy before surgery.  CT either failed to find lesions or identified tumors that weren’t there in half of the chemotherapy patients but only about a third of those who went directly to surgery.  Other factors making CT scans less accurate were more than three liver tumors and fatty deposits (steatosis) in more than 30 percent of liver tissue.  Benjamin Angliviel and the team from the Hôpital Ambroise Paré in Boulogne report their results in the May, 2009 issue of the Annals of Surgical Oncology.

Other Headlines

• Finding the best imaging strategies for the diagnosis, staging, and monitoring of cancer is among the 25 most important priorities for comparative-effectiveness research (CER) recommended by a new Institute of Medicine report.  Comparing the effectiveness of new colorectal cancer screening methods, including CT colonographyand FIT, to usual care with FOBT and colonoscopy to prevent colorectal cancer is among the second tier of 25.  The IOM report chose 100 priorities from an initial list of 1,300 as important for $1.1 billion in CER funding to help Americans make good health care decisions based on evidence from research.  Said Dr. Harold C. Sox, co-chair of the IOM panel, “Healthcare decisions too often are a matter of guesswork because we lack good evidence to inform them.”
• Cancer survivors share their stories of diagnosis and treatment on video talking about The Day I Found Out. Developed by the Seattle Cancer Care Alliance, the videos include several colon cancer patients including C3 advocate and stage IV survivor Anita Mitchell who talks about her oncologist who gave her hope when he said, “I have a plan for you.”  She says, “All I needed was that hope.”
• The FDA has issued new rules to help reduce Salmonella infections from eggs.   Large egg farmers will have to buy chicks from bacteria safe sources, keep facilities clean and bacteria-free, test their facilities regularly, and refrigerate eggs promptly for storage and shipment.  Salmonella enteritidis causes more than 140,000 illnesses every year, some of which are life-threatening.  FDA tells consumers to buy only refrigerated eggs, check for clean and uncracked shells, refrigerate eggs promptly at home, and cook eggs until yolks are firm.
• FDA: Vital Pharmaceuticals has recalled lots of its powdered dietary supplement Stealth Chocolate and Stealth Vanilla because it may be contaminated with Salmonella. Milk protein concentrate, one of the supplement’s ingredients, was recalled by the supplier.  The dietary supplements were sold nationwide, including at GNC stores.  Consumers with questions may contact Vital Pharmaceutical Inc. at 1-800-954-7904 or 954-641-0570 during the hours of 9 am – 5 pm, Monday through Friday.

The Food and Drug Administration has announced a voluntary recall of all varieties of Nestle® TOLL HOUSE® refrigerator cookie dough.  While no e. coli bacteria have been actually found in the dough, there have been a number of reports of consumers becoming ill after eating the raw dough.

Baking the cookies may not eliminate the risk of contamination because cooks may get bacteria on their hands or on other kitchen surfaces.

Nestle and the FDA emphasize that people should never eat raw cookie dough or other foods that are intended to be baked or cooked before eating.

The products involved in the voluntary recall include all varieties of Nestlé TOLL HOUSE refrigerated Cookie Bar Dough, Cookie Dough Tub; Cookie Dough Tube; Limited Edition Cookie Dough items; Seasonal Cookie Dough and Ultimates Cookie Bar Dough. A complete list is available from Nestle. It includes all varieties, not just chocolate chip.

The FDA and CDC are working with Nestle on a study of e. coli illness that may be related to raw cookie dough.  Since March 66 people have reported being sick in 28 different states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). No one has died.

The e. coli strain (E. coli O157:H7)  causes abdominal cramping, vomiting, and diarrhea, which may be bloody.  Young children and the elderly are at the highest risk of develooing  HUS which can lead to serious kidney damage and even death.

If you have had these symptoms after eating raw cookie dough, the FDA says to contact your doctor or health care provider right away.  All such illnesses should be reported to local or state health departments.

More information is available from Nestle by calling 1-800-559-5025 or by going to their website. Nestle says that consumers who have recalled cookie dough can return it to the place where they bought it for a full refund.

Note: If you make cookies at home from your own ingredients, be careful about tasting the dough or offering your kids the spoon to lick.  Raw eggs used in cookies may contain salmonella bacteria.  This is not the same bug as the e.coli involved in the Nestle recall, but can be as dangerous for you, your children, or a sick or elderly family members. Kate

FDA is advising consumers not to eat pistachios or food products containing them (such as pistachio bakery goods and pistachio ice cream) unless they can determine that the products do not contain pistachios from Setton Pistachio of Terra Bella, Inc., (“Setton”).

FDA is maintaining a searchable list of recalled products that contain Setton nuts. The CAL-PURE co-op of California pistachio growers  and the Western Pistachio Association list brands that do not contain Setton pistachios.

Cancer patients, especially those on chemotherapy, may have reduced immune systems that make them particularly vulnerable to Salmonella infection.