May 14, 2008

FDA: RLS Treatment Approved. Corn Bread & Muffin Mix Recall

FDA News Digest

May 12, 2008 _____________________________________

IN THIS WEEK’S ISSUE

» News

— Generic Versions of Restless Legs Syndrome Treatment Approved

— FDA OKs Room Temperature Formulation of Blood Clotting Therapy

» Congressional Testimony

» Safety Alerts/Recalls

NEWS

Generic Versions of Restless Legs Syndrome Treatment Approved

FDA has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate-to-severe restless legs syndrome. The approval covers a variety of dosages. Four companies have received approval to market the tablets.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01832.html

FDA OKs Room Temperature Formulation of Blood Clotting Therapy

FDA has approved a new formulation of the genetically engineered version of Factor VIIa, used to treat bleeding and prevent surgical bleeding in patients with hemophilia A or B. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years. This is helpful for healthcare facilities with limited refrigerated space, and it allows greater flexibility in disease management for both patients and doctors.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01833.html

CONGRESSIONAL TESTIMONY

May 1 — FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., appeared before the House Subcommittee on Health.

Subject: “Discussion Draft of The ‘Food And Drug Administration Globalization Act’ Legislation: Drug Safety”

http://www.fda.gov/ola/2008/fdaglobalact050108.html

April 29 — FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., appeared before the House Subcommittee on Oversight and Investigations.

Subject: FDA‘s ongoing heparin investigation

http://www.fda.gov/ola/2008/heparin042908.html

SAFETY ALERTS/RECALLS

Food Recall:

› Little Bay Baking and GFCFDiet Corn Bread and Muffin Mix, 12.6-oz. size

Reason for recall: may contain soy not declared on the label

http://www.fda.gov/oc/po/firmrecalls/littlebay05_08.html

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

Posted in FDA News
Tagged A, B, Factor VIIa, FDA News, GFCF Diet, Hemophilia, Heparin Investigation, Little Bay Baking

April 30, 2008

FDA News: Dog & Cat Food; Laws for Beef; Recall Soymilk

FDA News Digest

April 28, 2008 _____________________________________

IN THIS WEEK’S ISSUE

» News

n Pet Food Maker Ordered to Obtain Emergency Operating Permit

n New Regulation Strengthens Safeguards for Beef Consumers

n Drug Approved to Treat Bowel Disorder Crohn’s Disease

n Relistor Approved to Treat Opioid-Induced Constipation

» Testimony

» Safety Alerts/Recalls

__________________________________________

NEWS

Pet Food Maker Ordered to Obtain Emergency Operating Permit

FDA has issued an order requiring that Illinois-based Evanger’s Dog & Cat Food Co. Inc . obtain an emergency permit from FDA before its canned pet food products enter interstate commerce. A recent inspection revealed significant deviations from prescribed documentation, which could result in underprocessed pet foods that can allow the survival and growth of Clostridium botulinum, a bacterium that causes botulism in some animals as well as in humans. For Evanger’s to resume business, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01825.html

New Regulation Strengthens Safeguards for Beef Consumers

FDA has issued a final regulation barring certain cattle materials from all animal feed, including pet food. The rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as “mad cow disease”). The new measure builds on FDA’s 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01823.html

Drug Approved to Treat Bowel Disorder Crohn’s Disease

FDA has approved Cimzia (certolizumab pegol) to help sufferers of moderate-to-severe Crohn’s disease who have not responded to conventional therapies. Crohn’s disease is a chronic, inflammatory bowel disorder that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html

Relistor Approved to Treat Opioid-Induced Constipation

FDA has approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Such patients include those with a diagnosis of incurable cancer, end-stage chronic obstructive pulmonary disease from emphysema, heart failure, Alzheimer’s disease with dementia, HIV/AIDS or other advanced illnesses. Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from functioning. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01826.html

_________________________________

TESTIMONY

April 25 — FDA Office of Food Safety Deputy Director Don Kraemer appeared before the U.S.-China Economic and Security Review Commission Hearing on “Chinese Seafood: Safety and Trade Issues”

http://www.fda.gov/ola/2008/seafood042408.html

April 24 — FDA Center for Food Safety and Applied Nutrition Director Stephen F. Sundlof, DVM, appeared before the House Subcommittee on Health.

Subject: “Food and Cosmetic Provisions of the ‘Food and Drug Administration Globalization Act’ Discussion Draft Legislation”

http://www.fda.gov/ola/2008/fdaglobalact042408.html

April 22 — FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Oversight and Investigations

Subject: “FDA Actions to Improve Safety of Medical Products with Foreign Components”

http://www.fda.gov/ola/2008/foreigninspection042208.html

___________________________________________________

SAFETY ALERTS/RECALLS

Drug Recall:

› Bertek and UDL label Digitek (digoxin tablets, USP, all strengths) for oral use

Reason for recall: tablets may contain twice the approved level of active ingredient

http://www.fda.gov/oc/po/firmrecalls/actavis04_08.html

Food Recall:

› Silk Soymilk Chocolate Flavor, 11-ounce plastic single serve bottles printed with both a “use by” date of May 7, 2008 (printed as 05 07 08) and a Universal Product Code (UPC) of 2529360028

Reason for recall: product may contain milk protein not declared on label

http://www.fda.gov/oc/po/firmrecalls/whitewave04_08.html

Posted in FDA News
Tagged FDA News

April 1, 2008

FDA Warning: Total Body Formula, Yogurt, ED Vitamins

FDA News Digest

March 31, 2008

_____________________________________

IN THIS WEEK’S ISSUE

› FDA is advising consumers not to buy or use “Blue Steel” or “Hero” products, marketed as dietary supplements throughout the United States, because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect blood pressure level. They are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. They are labeled as dietary supplements but do not qualify as such because they contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in the ED drug Viagra.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01809.html

› FDA also is advising consumers not to buy or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html

Food Recalls:

› Honduran Cantaloupes grown by Agropecuaria Montelibano

Reason for recall: Salmonella contamination

http://www.fda.gov/oc/opacom/hottopics/cantaloupe.html

› Certain batches of Stonyfield Organic Fat Free Blueberry Yogurt, 6-oz. cups

Reason for recall: reported plastic or glass fragments in product

http://www.fda.gov/oc/po/firmrecalls/stonyfield03_08.html

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

_

Recommendations Made on Devices That Treat Blocked Heart Arteries

FDA has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, which are devices used to treat blocked heart arteries. FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines outline the agency’s recommendations for providing data to better address the clot issue and other potential safety concerns.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01810.html

25 Drugs, Biologics Identified for Safety Plan Requirements

FDA has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS). FDA can require manufacturers to submit a REMS when a drug first comes on the market or later if FDA becomes aware of new safety data about the drug. Manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01811.html

FDA Seeks Civil Penalties from California Maker of Hearing Aids

FDA is seeking a $2.2 million penalty against California hearing aid manufacturer Advanced Bionics, LLC, for violations of federal law, including manufacturing standards violations and the failure to notify the agency of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks. The hearing aids pose a risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01813.html

To view an archive of recent FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html._____________________________________________

CONSUMER HEALTH INFORMATION

Each week, we offer links to articles about FDA activities and FDA-regulated products. In the spotlight this week:

› Taking a Close Look at Ultrasound

http://www.fda.gov/consumer/updates/ultrasound032408.html

› Avoid Fetal “Keepsake” Images, Heartbeat Monitors

http://www.fda.gov/consumer/updates/keepsakevideo032408.html

To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html

Posted in FDA News
Tagged ED Vitamins, FDA News, Total Body Formula, Warnings, Yogurt

March 26, 2008

FDA… Food Recalls, Safety Alerts

FDA News Digest

March 24, 2008

_____________________________________

IN THIS WEEK’S ISSUE

» News

— FDA Approves New Medical Adhesive to Treat Burn Patients

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

__________________________________________

NEWS

FDA Approves New Medical Adhesive to Treat Burn Patients

FDA has approved Artiss, a medical adhesive for use in attaching skin grafts onto burn patients. The product contains fibrinogen and thrombin, two proteins essential in the clotting of blood. Artiss differs from other similar sealants because it contains a lower concentration of thrombin, allowing surgeons time to position skin grafts over burns before the graft begins to adhere to the skin.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01807.html

To view an archive of recent FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

_____________________________________________

SAFETY ALERTS/RECALLS

Safety Alert:

Following reports of 50 illnesses in 16 states, FDA has issued an import alert regarding cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer. Based on current information, fruit from this company appears to be associated with a Salmonella outbreak in the United States and Canada. The import alert advises FDA field offices that cantaloupes shipped to the United States by this company are to be detained. FDA also has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove any cantaloupes that come from this company.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01808.html

Food Recalls:

› Acme 4-pack Cinnamon Rolls with Icing (sold in New Jersey, Pennsylvania, Delaware, and Maryland)

Reason for recall: milk component not declared on label

http://www.fda.gov/oc/po/firmrecalls/acme03_08.html

› Certain lots of Bass Pro Shops Uncle Buck’s Light ‘n Krispy Original (8 oz. pouches and 22-oz. size) and Light ‘n Krispy Hot & Spicy (22-oz. size) fish batter mixes; sold in Bass Pro Shops nationwide

Reason for recall: milk component not declared on label

http://www.fda.gov/oc/po/firmrecalls/williams03_08.html

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated