Part of efforts outlined in agency’s new Food Protection Plan
The U.S. Food and Drug Administration's Office of Regulatory Affairs (ORA) today announced the award of three lab grants, designed to boost the food screening capabilities and spot radioactive material in food, resulting from deliberate or accidental contamination. These labs are part of the Food Emergency Response Network (FERN).

The three-year grants provide $250,000 a year for supplies, personnel, minor facility upgrades and training. Recipients of the grants are the Texas Department of State Health Services Laboratory, the New York Health Research/New York Department of Health, and the Wisconsin State Laboratory of Hygiene.

FDA's ORA will expand its testing program to address the threat to food safety through radiological terrorism events. ORA has developed radiological screening and analysis methodologies used to evaluate foods and food products.

The grants are targeted toward enhanced detection of radiological contamination and thus enhance the nation's overall capability to rapidly detect and respond to deliberate attacks on the food supply.

The grant awards further expand the FDA's ability to promote the integrated strategy for protecting the nation's food supply through the three core elements of prevention, intervention, and response, as outlined in the agency's Food Protection Plan. These funded labs will be involved in food defense surveillance testing as well as bolstering the FDA's emergency response efforts by increasing the capacity for testing of foods for radioactive contamination, intentional or accidental.

The selected laboratories will receive funds to assist in acquiring supplies, personnel, and facility upgrades. The labs will receive training in current food testing methodologies, participate in method development and validation, proficiency testing, and food defense surveillance assignments.

Two key project areas have been identified for the grant recipients. These areas involve the detection of radioactive contamination, utilizing the most advanced detection systems available.

FERN's mission is to integrate the nation's food-testing laboratories at the local, state, and federal levels into a network able to respond to emergencies involving biological, chemical, or radiological food contamination. The network can respond to emergencies related to agents in food and restore the public's confidence in the food supply.

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The U.S. Food and Drug Administration today announced that it has approved Nexavar (sorafenib) for use in patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer.

"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,” said Robert Justice, M.D., director of FDA's division of drug oncology products. "This is an important new treatment option for patients who are fighting this very difficult form of cancer."

According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. This type of cancer can be difficult to remove completely using surgery. If all of the cancer cannot be removed, the disease is usually fatal within three to six months. The American Cancer Society estimates that there will be 19,160 new cases and 16,780 deaths from cancer of the liver and intrahepatic bile duct in the United States in 2007.

Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.

FDA's approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not.

A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.

The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.

The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions. In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo.

Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.

Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach.

Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.

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Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.

FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.

Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.

FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.

In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.

FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.

Full text of the Early Communication about the Ongoing Safety Review can be found at: http://www.fda.gov/cder/drug/early_comm/varenicline.htm.


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The U.S. Food and Drug Administration has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine HCl) for nonprescription use. The nonprescription drug is approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older.  

The nonprescription Zyrtec products also are approved for the relief of itching due to hives in people 6 years of age and older, including adults.

"The approval of Zyrtec for nonprescription use offers an additional treatment option for children and adults," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research. "As for all nonprescription drugs, consumers and caregivers should read and carefully follow all directions on the labeling."

The tablets and chewable tablets are approved for adults and children 6 years of age and older:

for the treatment of the symptoms of hay fever and other respiratory allergies, and
to relieve the itching due to hives.
The syrup is approved for:

adults and children 2 years of age and older for the treatment of the symptoms of hay fever and other respiratory allergies, and
adults and children 6 years of age and older to relieve the itching due to hives.
The company will market two distinct Zyrtec products for each dosage form. One will provide directions for treating the symptoms of hay fever and other respiratory allergies. The other will contain directions for use to relieve the itching due to hives.

Zyrtec may cause drowsiness in some people at recommended doses. Other common side effects include fatigue and dry mouth.  

On November 9, 2007, the FDA announced that it had approved Zyrtec-D, a product which contains cetirizine HCl and pseudoephedrine HCl, for nonprescription use. Sales of the Zyrtec-D are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product and that it be located with the pharmacist. Nonprescription Zyrtec-D was approved for the relief of symptoms due to hay fever or other upper respiratory allergies such as runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also approved for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose due to hay fever and other upper respiratory allergies. Zyrtec-D is not approved for the relief of itching due to hives.  

Zyrtec is marketed and distributed by McNeil Consumer Healthcare, based in Fort Washington, Pa.

30-day extension to run through Dec. 26, 2007
The Food and Drug Administration today announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007. The comment period was set to expire on Nov. 26. Typically, comment periods for Federal rules is 90 days. The sunscreen rule, when finalized, will amend the 1999 FDA final rule on sunscreen products that protect against ultraviolet B (UVB) rays and incorporates new testing and labeling requirements for products that protect against ultraviolet A (UVA) rays.

On Aug. 27 the agency released to the public its proposed rule for over-the-counter (OTC) sunscreen products. FDA received nine requests to extend the comment period. One asked for an additional two months, eight for an additional nine months. The submissions cited the need for more time to complete laboratory testing and consumer studies on the proposed labeling system. By extending the comment period for 30 days, FDA is balancing industry concerns and the interests of public health to ensure that sunscreen products properly inform consumers of the level of protection they provide against UVA and UVB rays.

Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:

Federal eRulemaking Portal: www.regulations.gov
FDA Web site: www.fda.gov/dockets/ecomments

Written submissions can be submitted by fax or mail:

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax 301-827-6870

For more information:
FDA Web site for OTC drug products:
www.fda.gov/cder/Offices/OTC/consumer.htm

Background: On May 29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) that were being treated with either Prilosec or Nexium.  The studies were designed to assess the effectiveness of treatment with Prilosec, or Nexium, or surgery for severe GERD.  Participants were randomly assigned to receive treatment with either a drug (Prilosec in one study and Nexium in the other) or surgery. During the studies, cardiovascular events raised a question about whether  long-term use of these drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared to patients who received surgical treatment.  On Aug. 9, 2007 FDA released an "Early Communication of an Ongoing Safety Review" of these drugs.  The agency’s initial review determined that there was no increased risk of heart problems associated with long-term use of these drugs.  At FDA’s request, AstraZeneca submitted a large amount of additional information about these and other studies and FDA undertook a comprehensive review of all available data regarding this potential safety concern.  The following represents the agency’s current analysis of available data on these medications.

Current Information:  FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium.  While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified.  As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging.  FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled.  Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.

Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect. Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems.  FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.

About Prilosec and Nexium

Prilosec and Nexium are members of a class of drugs known as proton pump inhibitors (PPIs). Nexium (esomeprazole)  is the newer formulation of the original Prilosec (omeprazole) product. As prescription products, they are used to treat the symptoms of GERD and other conditions caused by excess stomach acid. PPIs work to decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis. They are also indicated for use with an antibiotic to treat gastric ulcers. Prilosec is also available as an over-the-counter medication to treat frequent heartburn.

The U.S. Food and Drug Administration today announced a new e-mail service that alerts subscribers whenever information is updated on certain FDA Web pages.

The service is free and available for a wide variety of FDA's Web pages, including food safety protection, medical product approvals and consumer health information.

"Being able to directly communicate with consumers, health care professionals and the regulated industry about the safety of our food supply and medical products is critical to FDA's ongoing commitment to protecting the public health," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "E-mail is the leading use of the Internet, and this service strengthens FDA's ability to keep its audiences informed quickly and effectively."

To receive e-mail alerts, subscribers need only click on the red envelope icon located on participating Web pages. Each e-mail update includes a direct link to the FDA Web page that has been updated.

Powered by GovDelivery, a private sector e-mail subscription management system used by several other federal agencies, the service allows subscribers the flexibility to personalize the information most important to them.

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry
Connection of genetic information with medication use can improve safe use of product
The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.

Carbamazepine is a drug used for treatment of epilepsy, bipolar disorder, and neuropathic pain. It is sold under the brand names Carbatrol, Equetro and Tegretol.

"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."

The prescribing information for these drugs already includes a warning that for all patients starting carbamazepine therapy, regardless of ethnicity, rare but severe and sometimes life-threatening skin reactions can occur. These life-threatening skin reactions include toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, itching and other symptoms.

The risk of these reactions is estimated to be about 1 to 6 per 10,000 new users of the drug in countries with mainly white populations. However, the risk is estimated to be about 10 times higher in some Asian countries.

The skin reaction warnings will be moved to the current boxed warning section of the labeling. The new recommendation that health care providers give patients with Asian ancestry a genetic test before starting treatment will also be added to the boxed warning section.

To screen for this genetic marker, a patient's blood can be drawn by a health care provider and the test administered at a laboratory. It is estimated that about 5 percent of patients being considered for treatment with carbamazepine are of Asian ancestry and would need to have this test.

Studies have found a strong association between certain serious skin reactions and an inherited variant of a gene, HLA-B* 1502, an immune system gene, found almost exclusively in people with Asian ancestry. Patients testing positive for this gene should not be treated with carbamazepine unless the benefit clearly outweighs the increased risk of these serious skin reactions.

Patients who have taken carbamazepine for more than a few months and not experienced any skin reactions are unlikely to ever experience these reactions, regardless of ancestry or genetic test results. Patients currently taking carbamazepine who are concerned about these skin reactions should not stop taking the drug without first consulting their health care provider.  

Carbatrol is manufactured by Shire Pharmaceuticals, Wayne, Penn.; Equetro is manufactured by Validus Pharmaceuticals Inc., Parsippany, N.J.; and Tegretol is manufactured by Novartis, East Hanover, N.J. Generic versions of carbamazepine are available.  

For Information

FDA Information for Healthcare Professionals: Carbamazepine
www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm

Orange or red powder that is applied to face or scalp: not intended for food use
The U.S. Food and Drug Administration is warning consumers not to use 3.5 oz. packages of Swad brand sindoor, an orange or red powder used in some traditional South Asian Pacific ceremonies that is applied to the face or scalp, imported by Raja Foods LLC of Skokie, Illinois because the product contains high levels of lead. Although the product was not intended to be sold for food use, its labeling is confusing and implies that it may be used as food. The Illinois Department of Public Health has confirmed two cases of lead poisoning in consumers who used the product as an ingredient in home cooked meals. Other uses of the product, including as a cosmetic, can also be dangerous due to the high lead levels.

Lead can be toxic to all humans but due to the risks it poses to a developing nervous system, women of childbearing age, pregnant women and their unborn children, and young children should be especially cautious and limit their exposure to lead. Symptoms of lead toxicity include: stomach aches, colic, nausea, vomiting, abnormal irritability, and insomnia. However, people with lead in their blood often do not exhibit symptoms. Permanent damage to the central nervous system from lead exposure can result in learning difficulties in school children as well as cause other long-term health problems such as kidney disease. Anyone who has consumed this product should consult his or her health care provider immediately.

At least 280 packages of Sindoor were distributed to grocery stores that specialize in foods from India in Colorado, Georgia, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Washington, and Wisconsin.

The front label of the bag states "SWAD BEST TASTE IN TOWN SINDOOR", "FOR RECIPE IDEAS VISIT OUR WEBSITE: WWW.RAJAFOODS.COM", and "PRODUCT OF INDIA." The back label states "Imported and Distributed by: Raja Foods, 8110, N. St. Louis Avenue, Skokie, ILL 60076", with a UPC of 0 51179 42236 0 and may have a sticker stating "NONEDIBLE".

Packages of Sindoor can be returned to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-800-7923 x 2860.

Consumers should report adverse events related to this product to MedWatch, the FDA’s voluntary reporting program: www.fda.gov/medwatch/report.htm, 800-332-1088, fax: 800-332-0178, mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.

The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), commonly called “Lou Gehrig’s Disease.”

Elizabeth Lerner, a.k.a. "Elizabeth Cooperman," 38, of Egg Harbor City, N.J., was sentenced on Dec. 12, 2007, in the U.S. District Court of New Jersey for defrauding two ALS patients and their families. She also was ordered to pay $35,390 in restitution to the victims of the scheme and a criminal fine of $7,500.

"The FDA's Office of Criminal Investigations aggressively pursues those that provide false hope to patients by making unproven medical claims to unsuspecting patients — many with serious or life-threatening conditions who are desperate for a medical cure," said Terry Vermillion, director of FDA's Office of Criminal Investigations.

Lerner and her co-conspirator Charlene C. DeMarco, 55, a former doctor of osteopathy in Egg Harbor City, were convicted in December 2006 of all charges contained in an 11-count federal indictment. The indictment included one count of conspiracy to commit mail and wire fraud, three counts of mail fraud, six counts of wire fraud, and one count of money laundering.

DeMarco was sentenced on September 2007 to 57 months in prison, ordered to pay $32,190 in restitution to victims of the scam, and to pay a criminal fine of $7,500.

Evidence showed that from October 2002 until November 2004, DeMarco and Lerner agreed to defraud ALS patients and their families by claiming they could treat ALS patients with stem cell therapy, even though they knew they could not. The defendants falsely told their patients and their families that DeMarco had previously received FDA approval to treat ALS.

Jurors heard testimony from 24 government witnesses and viewed hundreds of pieces of evidence regarding the defendants' scheme.

Prosecutors said that Lerner and DeMarco also attempted to defraud two patients and their families in Louisiana of more than $140,000 and successfully obtained more than $40,000 from the scheme. Witnesses described how Learner and DeMarco illegally laundered money they received and used the proceeds for personal expenses.

This case was prosecuted by the United States Attorney's Office for the District of New Jersey in Camden and was investigated by the FDA's Office of Criminal Investigations’ Metro Washington Field Office.

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