FDA Advisory: Denture Cleanser Allergic Reactions and Misuse

Denture Cleanser Allergic Reactions and Misuse

Audience: Dental healthcare professionals, patients
[Posted 02/26/2008] FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use. These events can occur soon after first use or after years of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for dental healthcare professionals and an 'Advice for Patients' document that can be accessed at the links below.

FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse.

[February 25, 2008 - Public Health Notification - FDA]
[February 25, 2008 - Advice for Patients - FDA]

tag: FDA Advisory, dental healthcare, denture cleansers, allergic reactions, persulfate, Public Health Notification

A Brochure That Could save Lives, "My Medicines".

Can carrying around a brochure help save your life? Yes, if it's the "My Medicines" brochure offered by FDA's Office of Women's Health (OWH). It's designed to help consumers track the medications they use.

My Medicines features a chart that allows you to list information about your prescription medicines, including the names of the medicines, how much you take, when you take them, what condition they are treating, and the number of refills.

The brochure also offers advice on how to use labeling information, how to avoid problems with your medicines, and questions you should ask your doctor or pharmacist about your prescriptions.

The brochure is available online at www.fda.gov/womens/taketimetocare/mymeds.html, as well as through the mail and from insurance providers, pharmacies, hospitals, health fairs, senior centers, and other venues.

A Case History

Coral Thomas, a resident of Clarksville, Tenn., is particularly glad that she picked up a My Medicines brochure during a visit to her doctor.

Thomas filled out the brochure, and placed it in her purse. It was there to help her when, at age 66, she suffered a heart attack. "The heart doctor at the hospital told me that (filling out and keeping the brochure) was the smartest thing I could have done," she reported.

Seeing that Thomas was taking daily treatments for high blood pressure and other conditions, the doctor changed his treatment plan. He later told Thomas he wished that every patient would carry such a list because it helps caregivers know the best way to proceed.

After her recovery, Thomas ordered dozens more My Medicines brochures and distributed them to her friends. "It's just the best thing to have," she says. "Women should carry one in their purses and keep a spare in their cars. Believe me, it can save your life."

Of course, the brochure can prove helpful to men as well.

Take Time to Care

My Medicines, which is available in 14 languages, is part of an outreach initiative called "Take Time to Care" (TTTC), which was launched by OWH in 1998 to provide reliable, science-based health information. Millions of My Medicine brochures have been distributed since the program's launch.

OWH now offers more than 50 easy-to-read publications that include fact sheets and medication guides. The following free materials, which are also available in many languages, can be downloaded at www.fda.gov/womens/pubs.html

Use Medicines Wisely

www.fda.gov/womens/taketimetocare/usemeds.html

Take Time To Care About Diabetes
www.fda.gov/womens/taketimetocare/diabetes/default.htm

Menopause and Hormones
www.fda.gov/womens/menopause/default.htm

For More Information

To order "My Medicines" through the mail, visit:
www.pueblo.gsa.gov/results.tpl?id1=16&startat=1&--woSECTIONSdatarq=16&--SECTIONSword=ww

Or call the Federal Citizen Information Center toll-free at 1-888-878-3256 and order publication 556R.

Free Publications for Women and Their Families
www.fda.gov/womens/pubs.html

FDA Office of Women's Health
www.fda.gov/womens/

tag: Medicine, food safty, FDA Services, Women's Health, prescription medicines, My Medicines brochure, high blood pressure, Take Time to Care, Menopause

Breast Cancer Test Is Effective, FDA

The first molecular-based laboratory test for detecting whether breast cancer has spread (metastasized) to nearby lymph nodes was approved by FDA on July 16, 2007. The GeneSearch BLN Assay, manufactured by Veridex, a Johnson & Johnson Company, of Warren , N.J., detects molecules that are abundant in breast tissue but scarce in a normal lymph node.

The Importance of Lymph Nodes

Lymph nodes are part of the system that helps protect the body against infection. The first lymph node that filters fluid from the breast is called the “sentinel node,” because that is where breast cancer cells are likely to spread first.

The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide the appropriate treatment for a woman with metastatic breast cancer.

“The GeneSearch BLN Assay offers a new approach to sentinel node testing,” says Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. “Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation.”

During a lumpectomy or mastectomy to remove a breast tumor, surgeons commonly remove the sentinel node for examination under a microscope. Sometimes the sentinel node is examined immediately, and if tumor cells are found, additional lymph nodes are removed.

A more extensive microscopic examination, requiring one to two days for results, is almost always performed. If tumor cells are only found with the later microscopic examination, the woman may require a second surgery to remove the remaining lymph nodes.

Test Effectiveness

In a clinical trial, the GeneSearch BLN Assay showed strong agreement with results from extensive microscopic examination of the lymph nodes of 416 women. The test accurately predicted nearly 88% of the time that breast cancer had spread in women with metastasis. Women without metastasis were identified accurately 94% of the time.

FDA Press Release (July 16, 2007)

Date Posted: July 17, 2007

tag: breast cancer, GeneSearch BLN Assay, Veridex, Lymph nodes, sentinel node, tumor cells, FDA, metastasis,

New and Generic Drug Approvals, February 21, 2008

• New and Generic Drug Approvals
  • ARESTIN (minocycline hydrochloride) Microspheres, OraPharma Inc., Labeling Revision
  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision
  • Avelox (moxifloxacin hydrochloride in NaCl) I.V., Bayer Pharma, Labeling Revision
  • Irinotecan Hydrochloride Injection, Watson Labs, Approval
  • Lexiva (fosamprenavir calcium) Tablets, GlaxoSmithKline, Labeling Revision
  • Pramipexole Dihydrochloride Tablets, Barr Labs, Approval
  • Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb, Labeling Revision
  • Ultram ER Extended-Release Tablets, Biovail Labs, Labeling Revision

tag: FDA Approval, Drug Approval, Ultram, Reyataz, Pramipexole, Lexiva, Irinotecan, Avelox, Avelox, ARESTIN

Grassplot brand Dried Pachyrhizus Recalled By Lion Pavilion LTD.

Another food product from China recalled;Lion Pavilion LTD. Recalls Grassplot brand Dried Pachyrhizus
tag: FDA Recall, food recall, Recallsglobal,

Xyntha, New Hemophilia Treatment Licensed By FDA

FOR IMMEDIATE RELEASE February 21, 2008

Media Inquiries: Peper Long, 301-827-0599 Consumer Inquiries: 888-INFO-FDA

FDA Licenses New Hemophilia Treatment

The U.S. Food and Drug Administration today licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.

The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.

Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A. Xyntha is also licensed to help prevent surgical bleeding in this patient population.

Xyntha is manufactured using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII. These CHO cells are free from known infectious agents, and Xyntha undergoes an additional process of viral inactivation. Also, the culture in which the cells are grown is free of any human or animal material.

"This product provides an additional treatment option for hemophilia A patients. This recombinant Factor VIII is produced without additives from human or animal material, which further minimizes any risk of infection from the product," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.

In clinical trials, Xyntha was shown to be effective at preventing or controlling bleeding, including preventing bleeding in surgery, for hemophilia A patients. Generally, the most frequently reported adverse reaction was headache. For those receiving Xyntha to prevent bleeding in surgery, the most frequently reported adverse reaction was fever. Most adverse reactions reported in either study were considered mild or moderate in severity.

In addition, two of 89 individuals who received 50 days of treatment with Xyntha, developed factor VIII inhibitors, which are antibodies that counteract treatment with factor VIII.

Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in Philadelphia.

tag: FDA Approval, FDA License, Hemophilia Treatment, hemophilia A, blood-clotting disorder, Xyntha Antihemophilic Factor (Recombinant) Plasma, anti-hemophilic factor, Xyntha, Wyeth Pharmaceuticals Inc.,

FDA Announces Permanent Injunction against Brownwood Acres Foods Inc., And Cherry Capital Services Inc.

FDA Announces Permanent Injunction against Food Companies, Executives
Claim products cure various health conditions

The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as "Chemicals found in Cherries may help fight diabetes." The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products' label and labeling comply with the law.

Under the terms of the consent decree, the companies have agreed to remove drug and unauthorized health claims from their labels, brochures, and Web sites, as well as references to other Web sites that contain such claims. They have also agreed to hire an independent expert to review the claims they make for their products and to certify that they have omitted all violative claims.

"The FDA will not tolerate unsubstantiated health claims that may mislead consumers," said Margaret O’K. Glavin, associate commissioner for regulatory affairs. "The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."

Brownwood Acres Foods Inc. and Cherry Capital Services Inc. manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, and salmon oil capsules.

The companies have a history of promoting unapproved claims on their product labels, brochures, and Web sites, stating that the products cure, treat, mitigate, or prevent various diseases. Most recently, the companies' Web sites referred customers to an apparently independent Web site, which was actually controlled by Brownwood Acres' president and contained similar unproven statements claiming benefits for their products.

The FDA can order the companies to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the federal Food, Drug, and Cosmetic Act or FDA regulations. The companies are also required to pay $1,000 per violation per day in the event they fail to comply with the consent decree.

The decree was signed by Judge Paul Maloney on Feb. 19 in the U.S. District Court for the Western District of Michigan.

tag: FDA Action, Flavonoid Sciences, Brownwood Acres Foods Inc., Cherry Capital Services Inc., juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, salmon oil capsules