FDA approves Inlyta to treat patients with a type of advanced kidney cancer

Jan. 27, 2012. The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Renal cell carcinoma is a type of kidney cancer that starts in the lining of very small tubes in the kidney. Inlyta works by blocking certain proteins called kinases that play a role in tumor growth and cancer progression. Inlyta is a pill that patients take twice a day.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options.”

Recently approved drugs for the treatment of kidney cancer include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009).

The safety and effectiveness of Inlyta were evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival, the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

The most common side effects observed in greater than 20 percent of patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia) and constipation.

Patients with high blood pressure should have it well-controlled before taking Inlyta. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal. Patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.

Inlyta is marketed by New York City-based Pfizer Inc.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.x

FDA approves Voraxaze to treat patients with toxic methotrexate levels

FDA NEWS RELEASE.For Immediate Release: Jan. 17, 2012. The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.

Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.

Voraxaze is an enzyme that rapidly reduces methotrexate levels by breaking the chemotherapy drug down to a form that can be eliminated from the body. Voraxaze is administered directly into a patient’s vein (intravenously).

“Prolonged exposure to high levels of methotrexate can result in kidney and liver damage, severe mouth sores, damage to the lining of the intestine, skin rashes, and death due to low blood counts,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Voraxaze is an important new treatment option for cancer patients aimed at preventing these toxicities associated with sustained high levels of methotrexate.”

Voraxaze has an orphan drug designation, given to therapies indicated for rare or specific disease populations.

A single clinical study of 22 patients evaluated the effectiveness of Voraxaze. All patients received Voraxaze treatment. The study considered treatment a success if the methotrexate level fell below a critical level within 15 minutes and stayed below the critical level for eight days. Ten of the 22 patients achieved this standard. Although not all patients experienced this result, Voraxaze eliminated 95 percent of the methotrexate in all patients.

A separate clinical study evaluated the safety of Voraxaze in 290 patients experiencing problems clearing methotrexate from their blood.

The most common side effects observed in greater than one percent of patients in the clinical study were low blood pressure (hypotension), headache, nausea, vomiting, flushing, and abnormal sensation (paraesthesia).

Voraxaze is marketed by BTG International Inc., West Conshohocken, Pa.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

Consumer Inquiries: 888-INFO-FDA

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FDA to protect important class of antimicrobial drugs for treating human illness

FDA NEWS RELEASE. For Immediate Release: Jan. 4,2012. The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.

Antimicrobial drugs are important for treating disease in both humans and animals. This new order takes into consideration the substantial public comment FDA received on a similar order that it issued in 2008, but revoked prior to implementation.

FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans. Prohibiting these uses is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens.

Cephalosporins are commonly used in humans to treat pneumonia as well as to treat skin and soft tissue infections. In addition, they are used in the treatment of pelvic inflammatory disease, diabetic foot infections, and urinary tract infections. If cephalosporins are not effective in treating these diseases, doctors may have to use drugs that are not as effective or that have greater side effects.  

In its order, FDA is prohibiting what are called “extralabel” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys, the so-called major species of food-producing animals. Specifically, the prohibited uses include:

using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration;

using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals);

using cephalosporin drugs for disease prevention.

In 2008, FDA issued and then revoked an order that prohibited extralabel uses of cephalosporins in food-producing animals with no exceptions. Today’s announcement responds to public comment and includes the following exceptions, which protect public health while considering animal health needs:

The order does not limit the use of cephapirin, an older cephalosporin drug that is not believed by FDA to contribute significantly to antimicrobial resistance.

Veterinarians will still be able to use or prescribe cephalosporins for limited extra-label use in cattle, swine, chickens or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.

Veterinarians may also use or prescribe cephalosporins for extralabel uses in minor species of food-producing animals such as ducks or rabbits.

"We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals," said Michael R. Taylor, Deputy Commissioner for Foods.

The new order of prohibition has a comment period that will begin on Jan. 6, 2012 and close on March 6, 2012. To comment on the order of prohibition, visit www.regulations.gov and enter FDA-2008-N-0326 in the keyword box. Following the comment period, the FDA will consider the comments prior to the order of prohibition going into effect on April 5, 2012.

Questions and Answers on FDA's Cephalosporin Order of Prohibition 

Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.govx

FDA expands use of Prevnar 13 vaccine for people ages 50 and older

FDA. For Immediate Release: December 30, 2011. Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

Pneumococcal pneumonia, caused when the bacterium Streptococcus pneumoniae infects the lungs, is the most common disease caused by this bacterium in adults. When the bacterium invades parts of the body that are normally free from germs, such as the blood or spinal fluid, the disease is considered “invasive.”

“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.” 

The new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.

In randomized, multi-center studies in the United States and Europe, people 50 and older received either Prevnar 13 or Pneumovax 23, a licensed pneumococcal vaccine also approved for use in this age group. The studies showed that for the 12 common serotypes, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.

The safety of Prevnar 13 was evaluated in about 6,000 people ages 50 and older who received Prevnar 13 and who had and had not previously received Pneumovax 23. Common adverse reactions reported with Prevnar 13 were pain, redness, and swelling at the injection site, limitation of movement of the injected arm, fatigue, headache, chills, decreased appetite, generalized muscle pain, and joint pain. Similar reactions were observed in those who received Pneumovax 23.

Accelerated approval is granted on the condition that a clinical trial is conducted during the post-approval marketing of the vaccine to verify the anticipated clinical benefit. An additional trial in 85,000 people ages 65 and older, with no previous history of receiving Pneumovax 23, is underway to confirm the clinical benefit of Prevnar 13 in the prevention of pneumococcal pneumonia.

Prevnar 13 is already approved for use in children ages 6 weeks through 5 years for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae and for the prevention of otitis media caused by seven of the serotypes of the bacterium. 

The approval of Prevnar 13 for adults 50 years and older supports the Department of Health and Human Services’ Healthy People 2020 objectives

Prevnar 13 is manufactured by Collegeville, Pa.-based Wyeth Pharmaceuticals.

For more information:

PREVNAR 13

Healthy People 2020

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov Consumer Inquiries: 888-INFO-FDAn

FDA approves shared system REMS for TIRF products

FDA. For Immediate Release: December 29, 2011. The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system.

TIRF medicines, which include the brand-name drugs Abstral, Actiq, Fentora, Lazanda, and Onsolis, are narcotic pain medicines called opiods used to manage pain in adults with cancer who routinely take other opioid pain medicines around-the-clock.

The shared system strategy, called the TIRF REMS Access Program, will be used by all sponsors of TIRF products and is expected to ease the burden on the health care system. The program will begin in March, 2012.Until that time, prescribers, patients, and pharmacies should continue to enroll in the individual REMS programs.

“This TIRF REMS will ensure safe use and access to these drugs for patients who need them,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the health care system.”

The goals of the TIRF REMS Access Program are to ensure patient access to important medications and mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:

prescribing and dispensing TIRF medicines only to appropriate patients, including use only in opioid-tolerant patients

preventing inappropriate conversion between fentanyl products

preventing accidental exposure to children and others for whom TIRF medicines were not prescribed

educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose.

Several TIRF products already have an individual REMS in place. Prescribers and pharmacies already enrolled in an individual REMS program for at least one TIRF medicine will automatically be transitioned to the shared TIRF REMS Access program.

Health care professionals who prescribe TIRF medicines that will only be used in an inpatient setting (hospitals, hospices, or long-term care facilities) will not be required to enroll in the TIRF REMS Access program. Similarly, patients who receive TIRF medicines in an inpatient setting are not required to enroll in the program. Long term care and hospice patients who obtain their medications from outpatient pharmacies must still be enrolled.

For more information:

TIRF REMS Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products

Media Inquiries: Shelly Burgess 301-796-4651,shelly.burgess@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

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FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull

FDA NEWS RELEASE.Dec. 2011. The U.S. Food and Drug Administration allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy. The device, called the Infrascanner Model 1000, can help health care providers identify patients with critical head injuries who need an immediate brain imaging study.

Intracranial hematomas occur when blood from a ruptured blood vessel collects within the brain or between the skull and the brain. As blood expands within the brain or in the narrow space between the brain and the skull, the brain becomes compressed. This can produce symptoms such as headaches, vomiting, dizziness, lethargy, weakness in the arm or leg on one side of the body, seizures, or unconsciousness. An intracranial hematoma can be life-threatening if it is not treated immediately.

According to the Centers for Disease Control and Prevention, each year about 1.7 million people in the United States experience a traumatic brain injury.

The Infrascanner, Model 1000, uses a scanner that directs near-infrared light, a wavelength of light that can penetrate tissue and bone, into the skull. Blood from intracranial hematomas absorbs the light differently than other areas of the brain. The scanner detects differences in light absorption (optical density) and transmits the information wirelessly to a display on a hand-held computer.

By comparing the optical density from a series of scans of specific areas on both sides of the skull, a trained health care provider can use the information provided by the device, in conjunction with other clinical information, to determine the likelihood of an intracranial hematoma and the need for further diagnostic procedures, such as a computed tomography (CT) scan.

“While patients with suspected brain injuries routinely receive a CT scan, this portable device offers emergency room physicians a non-invasive mechanism to aid in assessing whether an immediate CT scan is needed,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health.

The FDA reviewed data for the Infrascanner Model 1000 through the “de novo” classification process, a regulatory pathway for some low to moderate risk medical devices that are not comparable to a legally marketed device.

The FDA granted the de novo petition for the Infrascanner Model 1000 based on a review of data comparing results from 383 CT scans of adult subjects with Infrascanner scan results. The Infrascanner was able to detect nearly 75 percent of the hematomas detected by CT scan. When CT scans detected no hematoma, the Infrascanner detected no hematoma 82 percent of the time. The Infrascanner Model 1000, however, is not a substitute for a CT scan.

The FDA is specifying special controls in an accompanying regulation classifying the Infrascanner Model 1000 as a Class II device with special controls. The special controls provide information about specific risks that must be addressed by other manufacturers who may wish to market a similar device.

The Infrascanner Model 1000 is manufactured by InfraScan Inc. of Philadelphia.

For more information:

FDA: Medical Devices

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Consumer Inquiries: 888-INFO-FDAx

Scientific Standards for Studies on Modified Risk Tobacco Products

Dec. 14, 2011.WASHINGTON. A new Institute of Medicine report specifies the types of research that the Food and Drug Administration should require before allowing tobacco companies to sell or advertise ‘modified risk’ tobacco products as being capable of reducing the health risks of tobacco use.  While modified risk tobacco products could be one part of a comprehensive strategy to lower tobacco-related death and disease in the U.S., especially among tobacco users who are unable or unwilling to quit entirely, little is currently known about the products’ health effects and whether they pose less risk than traditional tobacco products. Examples of modified risk tobacco products may include e-cigarettes and tobacco lozenges.

Companies and other sponsors developing modified risk tobacco products should consider using FDA-approved independent third parties to oversee health and safety research on their products, adds the report, which was completed to fulfill a congressional mandate. Independent oversight would ensure that the data submitted to FDA are reliable and credible, and it could help re-engage the mainstream scientific community in research.  Because of the tobacco industry’s well-documented history of improper conduct, many institutions and scientists currently refuse to conduct or publish research supported by the tobacco industry.

“Right now there’s a shortage of scientific evidence on the health effects of modified risk tobacco products, and the tobacco industry currently lacks the trustworthiness, expertise, and infrastructure to produce it,” said Jane Henney, chair of the committee that wrote the report, and professor of medicine and public health sciences at the University of Cincinnati.  “Having trusted third parties oversee the conduct of research could help re-engage scientists and enable generation of credible research data on the health effects of these products.”

The Family Smoking Prevention and Tobacco Control Act of 2009 requires that modified-risk tobacco products undergo a pre-market approval process similar to drugs and devices.  According to the act, a company that wants to market a lower risk tobacco product in the U.S. must offer scientific proof to FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole.  The act also directed FDA to consult with IOM on how scientific studies of modified risk tobacco products should be designed and conducted.

The IOM’s report says that the studies should examine all of the areas needed to forecast and monitor a proposed product’s impact on public health, including its composition and addiction potential; the amount of human exposure to harmful components; perceptions about the product’s effects and likelihood of addiction; and effects on human health.  Studies should be generalizable to the whole population and should also include populations of special relevance, including current and former smokers, beginning smokers, adolescents, and populations at high risk for tobacco use.

While studies submitted to FDA to demonstrate products’ safety are usually conducted or sponsored by the companies themselves, the tobacco industry at present lacks the capacity and expertise to conduct such research, the report says.  The industry’s history of improper manipulation of data undermined the credibility of its research and left it isolated from the mainstream scientific community.  Many major universities have policies against acceptance of tobacco funding, for example, and many high-impact scientific and medical journals will not accept manuscripts supported by the tobacco industry.

Using independent, FDA-approved third parties to conduct, provide oversight of, and distribute funding for research could distance the influence and reputation of the tobacco industry from the scientists who are researching their products.  Examples of third-party partnerships between industry and government include the Health Effects Institute and the Reagan-Udall Foundation. No similar organization currently exists for the tobacco industry.

Making data publicly available will also build public trust and will allow for independent analysis of data and methods, the report says.  FDA should require sponsors of modified risk tobacco products to place all data generated during a product’s development and marketing in a public repository selected by the agency.  

FDA should also require that studies offered in support of an application to market modified risk tobacco products conform to established standards of good research governance, including appropriately qualified investigators, transparency, independent institutional review board or ethical review, and adherence to federal regulations that ensure the protection of human participants in biomedical research.

The study was sponsored by the Food and Drug Administration.  Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. 

Scientific Standards for Studies on Modified Risk Tobacco Products

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FDA takes enforcement action against Pennsylvania dietary supplement maker

FDA NEWS RELEASE.For Immediate Release:Nov. 23,2011.The FDA today took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.

This is the first time FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations. The cGMPs for dietary supplements went into effect in 2007, in a stepped process based on company size. This company's compliance date came into effect in 2010, and they did not meet the relevant cGMP requirements after that date.

The FDA requested the permanent injunction against ATF Fitness Products Inc. (ATF), Manufacturing ATF Dedicated Excellence, Inc. (MADE), and James G. Vercellotti of Oakmont, Pa., owner and operator of both companies. The cGMP regulations require manufacturers to ensure quality in their dietary supplements by controlling all aspects of their processes and procedures. MADE makes more than 400 dietary supplements, including vitamins and minerals, under the brands “Sci-Fit,” “Nature’s Science” and “For Store Only.” ATF purchases dietary supplements exclusively from MADE and distributes them throughout the United States.

“Dietary supplements have a significant role in the public’s health,” said Dara Corrigan, associate commissioner for regulatory affairs.  “Today’s injunction reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes.”

The government's complaint, filed Nov. 23, 2011, in the U.S. District Court for the Western District of Pennsylvania, alleges that in addition to “adulterating” and “misbranding” their final products, the manufacturer and its owner failed to report serious adverse events associated with their products. In one case an individual who consumed one of the products reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For more information:

Warning Letter, March 11, 2004http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm170182.htm1

Warning Letter, November 19, 2004http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2004/ucm146681.htm2

Seizure, January 12, 2006http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108577.htm3

Media Inquiries: Pat El-Hinnawy, 301-796-4763 or 202-557-6531, patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep

FDA NEWS RELEASE.For Immediate Release:Nov. 23,2011.The U.S. Food and Drug Administration  approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.

Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause excessive daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.

Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien.  Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.

“For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking,” said Robert Temple, M.D., deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research. “With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.”

Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug had a shorter time to fall back asleep after waking compared to people taking an inactive pill (placebo). The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.

Like other sleep medicines, Intermezzo may cause serious side effects, including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking—without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy.

Intermezzo is a federally controlled substance because it can be abused or lead to dependence.

Intermezzo is made by Transcept Pharmaceuticals Inc. of Port Richmond, Calif.

For information:

FDA: Approved Drugs: Questions and Answers

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA permits marketing of a system to repair failed, problematic fix for aortic aneurysms

FDA NEWS RELEASE. For Immediate Release: Nov. 21, 2011.FDA. The U.S. Food and Drug Administration today allowed marketing of the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large aortic aneurysm, a bulge in the large blood vessel that carries blood away from the heart.

FDA’s action will provide surgeons with a minimally-invasive option for repair of aortic endografts (endovascular grafts) that are not properly positioned. Aortic aneurysms can, over time, become weak and result in a life-threatening rupture. The endograft is placed inside the aorta to seal off the aneurysm and direct blood away from it.

The Aptus EndoStapling system is a cassette of nickel-cobalt corkscrew-shaped staples that is loaded into a long, thin, tube-like delivery catheter. The catheter is inserted into an artery in the leg and directed through the arteries to the failed endograft. Using a controller on the handle of the catheter, the surgeon applies one staple at a time around the top edge of the endograft to anchor the device and repair the endograft-artery seal.

“Leakage between the top end of the endograft and the aorta wall is a known complication of endograft implants that can be successfully treated,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The Aptus EndoStapling System provides a less invasive option than open surgery to access and repair these leaks.”

The FDA reviewed data for the Aptus Endostapling System through the de novo reclassification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not comparable to an already legally marketed device.

FDA granted the de novo petition for the EndoStapling System based on review of data from 154 patients who were implanted with 810 EndoStaples. Patients were monitored with routine followup CT scans. After a year, none of the EndoStaples had fractured and no patients experienced endograft movement (migration); one subject needed an additional intervention to address an endoleak.

The Aptus EndoStapling System is for use in patients whose endovascular grafts have moved, exhibit endoleaks, or are at risk for these complications and additional intervention is needed to reattach the graft and seal off the aneurysm.

The Aptus EndoStapling System is manufactured by Aptus Endosystems Inc. of Sunnyvale, Calif.

For more information:

FDA: Medical Devices

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov. Consumer Inquiries: 888-INFO-

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA approves Eylea for eye disorder in older people

FDA NEWS RELEASE.For Immediate Release: Nov. 18,2011. Maintains clearness of vision in those with wet age-related macular degeneration.The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.

AMD gradually destroys a person’s sharp, central vision. It affects the macula, the part of the eye that allows people to see fine detail needed to do daily tasks such as reading and driving.

There are two forms of AMD, a wet form and a dry form. The wet form of AMD includes the growth of abnormal blood vessels. The blood vessels can leak fluid into the central part of the retina, also known as the macula. When fluid leaks into the macula, the macula thickens and vision loss occurs. An early symptom of wet AMD occurs when straight lines appear to be wavy.

“Eylea is an important new treatment option for adults with wet AMD,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “It is a potentially blinding disease and the availability of new treatment options is important.”

The safety and effectiveness of Eylea was evaluated in two clinical trials involving 2,412 adult patients. People in the study received either Eylea or Lucentis (ranibizumab injection). The primary endpoint in each study was a patient’s clearness of vision (visual acuity) after one year of treatment.

Eylea is injected into the eye either every four weeks or every eight weeks by an ophthalmologist. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity.

The most commonly reported side effects in patients receiving Eylea included eye pain, blood at the injection site (conjunctival hemorrhage), the appearance of floating spots in a person’s vision (vitreous floaters), clouding of the eye lens (cataract), and an increase in eye pressure.

Eylea should not be used in those who have an active eye infection or active ocular inflammation. Eylea has not been studied in pregnant women, so the treatment should be used only in pregnant women if the potential benefits of the treatment outweigh any potential risks. Age related macular degeneration does not occur in children and Eylea has not been studied in children.

Other FDA-approved treatment options for wet AMD include: Visudyne (verteporfin for injection) approved in 2000, Macugen (pegaptanib sodium injection) approved in 2004, and Lucentis (ranibizumab injection) approved in 2006.

Eylea is marketed by Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc.

For more information:

FDA: Spotlight on Drug Innovation – Update of FDA’s novel drug approvals in 2011

NEI: Facts about Age-Related Macular Degeneration

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov. Consumer Inquiries: 888-INFO-FDA

FDA warns consumers not to eat one batch of Loyd Grossman Korma Sauce

FDA PRESS RELEASE.For Immediate Release: Nov. 18,2011. FDA warns consumers not to eat one batch of Loyd Grossman Korma Sauce. This product may put consumers at risk for botulism.FDA is warning consumers not to eat Loyd Grossman Korma Sauce in 350 ml jars with the batch code 1218R and sell by date of February 2013. The distributor of this product, Premier Foods in England, is recalling this batch of Loyd Grossman Korma Sauce. This product has been linked to two cases of botulism in Scotland.

There are no reported cases of illness related to this product in the United States. The product is not believed to be distributed in the United States, but consumers may have obtained it through internet sales. Consumers are warned not to use the product even if it does not look or smell spoiled. Consumers should dispose of this product in a sealed container and place it in a trash receptacle for non-recyclable trash outside of the home in a manner that ensures people and animals, including wild animals, cannot get to it. Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Trade Inquiries: Sebastian Cianci, 301-436-2291, sebastian.cianci@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

What is the Problem?The Food Standards Agency of the United Kingdom has reported two cases of botulism in Scotland. The consumption of Loyd Grossman Korma Sauce in 350 ml jars with the batch code 1218R and sell by date of February 2013 has been linked to these illnesses.

What are the Symptoms of Illness/Injury?Botulism is a serious, potentially fatal illness caused by eating food contaminated with botulinum toxin. Although cases are rare, botulism attacks the nervous system, and in its severe forms, can cause respiratory failure. Symptoms include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness. Symptoms usually begin 18-36 hours after eating contaminated food, but they can occur as early as six hours or as late as 10 days.

Who is at Risk?Anyone who eats food contaminated with botulinum toxin – whether adults or children – is at risk and can be affected.

What Do Consumers Need To Do?
Consumers should not eat Loyd Grossman Korma Sauce in 350 ml jars with the batch code 1218R and sell by date of February 2013. Consumers should dispose of this product in a sealed container and place it in a trash receptacle for non-recyclable trash outside of the home in a manner that ensures people and animals, including wild animals, cannot get to it. Additional instructions for safe disposal can be found at www.cdc.gov/botulism/botulism_faq.htm1. Consumers exhibiting any symptoms of botulism should see a health care provider immediately.

What Does the Product Look Like? The recall of this product includes Loyd Grossman Korma Sauce in 350 ml glass jars with the batch code 1218R and sell by date of February 2013 printed on the neck of the jars as follows:

Feb 2013
1218R

A time code will be stamped below this information.

Where is it Distributed? The FDA is not aware of U.S distribution of Loyd Grossman Korma Sauce, but is issuing this consumer advisory out of an abundance of caution because the product is available to U.S. consumers through internet sales.

The information in this press release reflects the FDA’s best effort to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.

For more information:

FoodSafety.gov on botulism: http://www.foodsafety.gov/poisoning/causes/bacteriaviruses/botulism/index.html2

CDC on botulism: http://www.cdc.gov/nczved/divisions/dfbmd/diseases/botulism/3

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA approves first supplemental test for Chagas disease

FDA NEWS RELEASE.For Immediate Release:Nov. 18, 2011.The U.S. Food and Drug Administration today approved the first test for use as an additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi (T. cruzi). T. cruzi causes Chagas disease, a serious and potentially fatal parasitic infection.

The test, called the ABBOTT ESA Chagas [Trypanosoma cruzi (E. coli, Recombinant) Antigen], is an in vitro enzyme strip assay for the qualitative detection of antibodies to T. cruzi. There are currently two donor screening tests licensed to detect antibodies to T. cruzi; however, this will be the first test licensed as a supplemental test.

“This test will help health care professionals to provide counseling to donors with positive screening test results,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Chagas disease is mainly spread by blood-sucking insects infected with T. cruzi. Chagas disease can also be spread through blood transfusion, organ transplants, and from mother to unborn child. The estimated number of persons living in the United States infected with T. cruzi, and at risk for developing Chagas disease, is 300,000 or more.

More than 5,000 donors with positive test results on a screening test have been identified since national screening of the blood supply was instituted in early 2007.

The Abbott ESA Chagas assay is manufactured by Abbott Laboratories, based in Abbott Park, Ill.

For more information:
Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay)1
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays2

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov, Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The J.M. Smucker Company Announces a Limited Voluntary Recall on Two Specific Best-If-Used-By Dates of 16 oz. Smucker’s® Natural Peanut Butter Chunky Due to Possible Health Risk

U.S. Food and Drug Administration (FDA). FOR IMMEDIATE RELEASE - November 17, 2011 - The J.M. Smucker Company today announced a limited voluntary recall on two specific Best-If-Used-By dates of 16 oz. Smucker’s® Natural Peanut Butter Chunky because it may be contaminated with Salmonella, an organism that 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. For more information, please visit the Centers for Disease Control and Prevention’s website at www.cdc.gov¹.

This product was distributed in: Arkansas, Colorado, Delaware, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Wisconsin, and the District of Columbia.

The affected product, which is packaged in 16 oz. jars, is as follows:

• UPC: 5150001701 (located on the side of the jar's label below the bar code)
• Production Codes: 1307004 and 1308004
• Best-If-Used-By dates: August 3, 2012 and August 4, 2012
• Chunky product only (not creamy)
• Impacted product would have been purchased between November 8 - 17, 2011

No other products of The J.M. Smucker Company are affected by this recall.

No illnesses related to this issue have been reported and the product is being recalled out of an abundance of caution for consumer safety.

The recall was initiated as the result of a routine sampling program by the company, which revealed that these finished products may contain the bacteria.

Consumers who have purchased Smucker’s Natural Peanut Butter Chunky with the above Production Code and Best-If-Used-By dates are urged to discard the product immediately and call the company at 1-888-550-9555 for a replacement coupon. The company may require proof of purchase. Consumers with questions can contact the company to speak to a customer service representative at 1-888-550-9555 between Monday through Friday from 9:00 AM - 7:00 PM.

The recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

Contact:Consumer 888-550-9555
Maribeth Badertscher Vice President, Corporate Communications 330-682-3000

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.