Saturday, December 11, 2010

FDA SUNDAY Pfizer Withdraws Thelin; Blood Pressure Drug Linked to Fatal Liver Damage

Pfizer Inc. said Friday it is pulling its blood pressure drug Thelin off the market and stopping all clinical trials because the drug can cause fatal liver damage.
Thelin is sold in the European Union, Canada, and Australia as an oral treatment for severe pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. Pfizer said two patients who were taking Thelin died during a clinical trial, and a review of data from clinical studies and post-marketing reports showed a new link to liver injury.Liver damage was a known side effect of Thelin and similar drugs, the company said, but the review uncovered a link to liver damage that was not tied to identifiable risk factors.
It said the problem was unlikely to be detected by routine monitoring, and in some cases, the problems did not go away after patients stopped taking Thelin.Pfizer said the withdrawal was voluntary and added that it has withdrawn its filing for marketing approval in the U.S.Since there are other treatment options, Pfizer said the benefits of Thelin don't outweigh the risks. It is stopping all studies of the drug, which Pfizer acquired in 2008 when it bought Encysive Pharmaceuticals Inc. Encysive had been trying to win marketing approval for Thelin since 2005, but the Food and Drug Administration said it was not effective enough.
Other agencies only approved the drug for hypertension that was so debilitating that patients' physical activity was severely limited.The New York company said worldwide sales of Thelin, or sitaxsentan, totaled $44.4 million in the first nine months of 2010.Copyright 2010 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press.
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Johnson & Johnson Recalls Rolaids After Complaints
Reuters) -
Johnson & Johnson issued a recall of its Softchews Rolaids antacids on Thursday after consumers reported finding wood and metal bits in the tablets.
J&J, which recalled some Rolaids products in November, said it was voluntarily recalling all lots of its Softchews products after potentially uncovering problems with a third-party manufacturer that left particles in the medicines.

The company also recalled the products in Canada.
"While our investigation is ongoing we have suspended production" of the recalled products, McNeil said in a statement. It will not begin manufacturing the antacids again until the problems have been fixed, the company added.
Consumers who bought those products should not use them, the company said. Representatives for J&J did not return calls seeking additional comment.
On November 23, McNeil announced it was recalling 71,000 packages of a cherry flavored, extra-strength version of Rolaids following consumer complaints of "an uncharacteristic consistency or texture" that was linked to crystallized sugar.
Additional reporting by Bill Berkrot in New York.
Editing by Robert MacMillan, Bernard Orr)


Skillets Sold By QVC Recalled
Updated: Friday, 10 Dec 2010, 4:31 PM MSTPublished : Friday, 10 Dec 2010, 4:31 PM MST
About 7,500 enamel-coated, 8-inch cast iron skillets sold by QVC, of West Chester, Pa. have been recalled.
Small pieces of the enamel coating can pop off when the skillet is heated, posing a burn hazard.
Five reports of the enamel coming off were received, and two people reported burns.
The Technique brand skillet was manufactured in China. "Technique" is printed on the bottom of the pan.
The recalled product was sold through QVC's televised shopping programs, at its website and at its retail and employee stores from Aug. 2009 through Sept. 2010 for prices ranging from $28 to $35.
Consumers should stop using the recalled products immediately. The purchasers that the companies were able to identify were mailed information on how to conduct a return. But consumers who bought the skillets at a QVC store should return it there for a full refund.
For more information, call QVC at 800-367-9444 or go to the company's website at http://www.qvc.com/ .


Bumble Bee Canned Chicken Salad Recalled
Updated: Monday, 06 Dec 2010, 6:00 PM MST
Published : Monday, 06 Dec 2010, 6:00 PM MST
(NewsCore) -

And you thought canned chicken salad could not get any worse.
About 72,000 pounds of Bumble Bee brand canned chicken salad products were recalled Monday after consumers complained of finding small pieces of hard plastic in the meat, according to the US Department of Agriculture's safety arm.

The Suter Company, which manufactures the product, recalled certain 8.2-ounce packages of "Bumble Bee Lunch on the Run Chicken Salad Complete Lunch Kit," and certain 3.5-ounce packages of "Bumble Bee Chicken Salad with Crackers," the US Food Safety and Inspection Service said on its website.

The cans of chicken salad bear the establishment number "P-169" inside the USDA mark of inspection and have a lot code of "0225XXQBC" printed on the package.
The chicken salad products were assembled between August 14 and August 28, 2010, and shipped to distributors nationwide.

"FSIS has not received any reports of injury at this time," the USDA said in a statement. "Anyone concerned about an injury from consumption of this product should contact a physician."
For more information, call 815-895-9186 or visit http://www.fsis.usda.gov/News_&_Events/Recall_064_2010_Release/index.asp.

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FDA NEWS RELEASE
For Immediate Release: Dec. 15, 2010
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA warns consumers to avoid Man Up Now capsules
Product marketed for sexual enhancement contains potentially dangerous ingredient

The U.S. Food and Drug Administration is warning consumers not to use Man Up Now capsules, marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

Man Up Now claims to be “herbal” and “all natural,” and consumers may mistakenly assume the product is harmless and poses no health risk.

Consumers who have Man Up Now capsules should stop using them immediately. The FDA analyzed Man Up Now and determined that it contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply that can lead to dizziness or lightheadedness.

Man Up Now, distributed by Synergy Distribution LLC, is sold on Internet sites, online marketplaces, and possibly in retail outlets in single, double, and triple blister packs, and in six-, 12-, and 30-count capsule bottles.

To date, the FDA is not aware of any adverse events associated with the use of the product. However, sexual enhancement products that claim to work as well as prescription products, but that contain prescription strength drugs, are likely to expose unknowing consumers to unpredictable risks and the potential for injury or death.

The FDA has found many products marketed as dietary supplements for sexual enhancement during the past several years that can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients. Sexual enhancement products promising rapid effects such as working in minutes to hours, or long-lasting effects such as 24 hours to 72 hours, are likely to contain ingredients in FDA-approved drugs or variations of those ingredients.
The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
Complete and submit the report online: www.fda.gov/MedWatch/report.htm
Download form or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 800-FDA-0178.
For more information:
Hidden Risks of Erectile Dysfunction: ‘Treatments’ Sold Online
http://www.fda.gov/NewsEvents/Newsroom
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Mojave Foods Corporation Initiates Recall Due to Possible Health Risk from Walnut Ingredient

Contact:Craig Berger 323-890-8900, Extension 133

FOR IMMEDIATE RELEASE - LOS ANGELES, CA, DECEMBER 8, 2010 –

Mojave Foods Corporation is initiating a recall of sixty (60) packages of El Guapo Shelled Walnuts 1 OZ, date code 5527, manufactured with walnuts supplied by Atlas Walnuts, Visalia, California, because we were advised by the supplier that the ingredient has the potential to be contaminated with Salmonella.

“Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms) endocarditis and arthritis.”
To date, no illnesses have been associated with this Mojave product. The recalled product was distributed only in southern California and sold in retail stores. The following product is being recalled.

El Guapo Nuez Entera / Shelled Walnuts sold in 1-ounce packages, UPC 4498933144, date code 5527. The code date is embossed on the front of the package under the El Guapo banner. Consumers are urged to not consume the recalled product and to destroy it. Contact the Mojave Customer Service number at 1-800-995-8906, Extension 114 for a replacement or reimbursement. Live assistance is available on the phone from 8:30 a.m. to 5:00 p.m. PST, Monday through Friday.

http://www.fda.gov/Safety/Recalls/ucm236227.htm

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Recalled In December

December 07, 2010 - Pablo’s Produce, Inc. Recalls One Lot of Cilantro because of Possible Health Risk14

December 06, 2010 -S&S Food Inc. Issues An Alert On Uneviscerated Fish15

December 02, 2010 - Intelli Health Products, Issues an Expansion to All Lots of their Voluntary Nationwide Recall of Duro Extend Capsules for Men Marketed as Dietary Supplements16

Written by: FDA · Filed Under FDA Press Releases

Children’s BENADRYL® Allergy FASTMELT® Tablets and Junior Strength MOTRIN® Caplets Recalled
December 1, 2010
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is recalling all product lots of Children’s BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength MOTRIN® Caplets, 24 count, that were distributed in the United States.


Recall of Mylanta and Alternagel Liquid Products
November 29, 2010
RECALL OF MYLANTA AND ALTERNAGEL LIQUID PRODUCTS

CONTACT: CONSUMER CARE CENTER 1-800-469-5268

FOR IMMEDIATE RELEASE – NOVEMBER 29, 2010 – IN CONSULTATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), JOHNSON & JOHNSON-MERCK CONSUMER PHARMACEUTICALS, CO. (JJMCP) IS RECALLING, FROM THE WHOLESALE AND RETAIL LEVEL, TWELVE MYLANTA® LIQUID PRODUCTS AND ONE ALTERNAGEL® LIQUID PRODUCT. JJMCP IS CONDUCTING THE RECALL IN ORDER TO UPDATE THE LABELING FOR THESE PRODUCTS. THE SPECIFIC PRODUCTS INVOLVED, LISTED BELOW, ARE BEING RECALLED IN THE UNITED STATES AND PUERTO RICO.


Three Tylenol Cold Multi-Symptom Liquid Products Recalled
November 28, 2010
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling, from the wholesale and retail level, three TYLENOL® Cold Multi-Symptom liquid products in order to update the labeling for these products. The specific products involved, listed below, are sold in the United States.

****Rolaids Also Recalled In November
ROLAIDS® Extra Strength Softchews Recall
November 28, 2010
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of one product lot of ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package distributed in the United States.

Advanced Bionics Cochlear Implant Recall – Recalled HiRes 90K Hearing Aid Device
November 25, 2010
Advanced Bionics (AB) is recalling their HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This implanted hearing aid recall is in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations after 8-10 days beyond initial activation of their HiRes 90k cochlear implant device.

WalkMed Infusion Issues Nationwide Recall of Triton Pole Mount Infusion Pumps
November 25, 2010
This is an update to a previously announced recall. WalkMed Infusion LLC, Englewood, Colorado, is conducting a nationwide recall of Triton Pole Mount Infusion Pumps. The reason for this recall is that the pump door open alarm does not always work on all pumps to alert the user that the pump door is open. In this state, the pump can still run even though the pump door may be open and could result in a free flow perfusion, and may cause serious injury or death.

Basic Facts About Your Prescription

Why am I taking this medicine?

Have your doctor include the reason on the prescription label; for example, "Take two in the morning for high blood pressure."
What is the medication's brand name?
What is the generic name?
Is there a generic version of the medication that offers the same benefits?
How much should I take and how often?
Do I take it at a particular time of day?

For example, does three times a day mean every 8 hours or one at each meal?
Are there other instructions for taking the medication?
Should the medication be taken with a full glass of water?
Should it be taken with or without food?
How soon will the medication start working after I begin taking it?
Is there any printed information I can have about this medicine?
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While taking this medication, should I avoid alcohol?

Are there other beverages or foods I should avoid?
Will any of my other prescription drugs interact with this one? How so?
If I experience such interactions, should I stop taking the other drug while using this one?
Will any vitamins or herbal supplements affect this drug (or can it affect them)?
What about over-the-counter (OTC) drugs? Are there any I should avoid?

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Other Important Considerations

What are the drug's potential side effects?

How serious are they? How can I avoid them?
What should I do if I experience side effects? Should I stop taking the drug? Should I call my doctor?
Are there any activities (such as driving) that I should avoid while on this medication?
Should I avoid exertion while taking this medication?

How will I know if the drug is working?
What happens if I get better? Should I finish the prescription or stop taking it?
What if I don't feel better or if I get worse? How long should I wait before contacting the doctor?
What should I do if I miss a dose? Should I take it immediately or should I skip it, and wait for the next?
Will I need prescription refills? If so, can I get them without a doctor's authorization?
Do I need any blood tests, other lab work or x-rays to monitor the effects (or side effects) of this drug?

Storage and Leftover Medication

How do I store this medication? Should it be refrigerated?
When does it expire?
If there's any left over, what should I do with it?
It's a good idea to print out these questions and bring them to the doctor's office or pharmacy. Keep the questions and answers, and give a copy to a friend or family member. You may also want to bring a friend or family member to jot down the answers. If no one can go with you, a tape recorder can help you keep track of the information.

Try to use the same pharmacy for all your prescriptions, keeping all the information in one place. It's also a good idea to maintain your own up-to-date list of all medicines, vitamins and dietary supplements you're currently taking.

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