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The FDA has approved Ranexa (ranolazine) to treat chronic angina. Ranexa is the first drug approved to treat this condition in over 10 years. Because Ranexa affects electrical conduction in the heart, it should be used only by people who have not responded to other anti-anginal drugs, such as long-acting nitrates, calcium channel blockers, and beta blockers.
People who have chronic angina have episodes of chest pain, pressure, or discomfort that occur during exercise because the heart muscle is not getting enough oxygen. The most common cause of angina is coronary heart disease, in which the coronary arteries that supply the heart with oxygen-rich blood become blocked with plaque deposits.
According to the American Heart Association, nearly 7 million Americans are diagnosed with angina every year. Acute attacks of angina are treated with nitroglycerin placed under the tongue, whereas treatments for chronic angina are given to increase the amount of exercise a person can do before angina occurs.
"Chronic angina limits people's activities," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "The approval of Ranexa provides a new treatment option for Americans who continue to suffer symptoms of angina despite using other angina drugs."
In clinical trials, Ranexa appeared to be less effective in women than in men. Common side effects included dizziness, headache, constipation, and nausea.
Ranexa is manufactured by CV Therapeutics Inc. in Palo Alto, Calif.
The FDA has published final guidance to reduce the risk of patients becoming entrapped in hospital beds. Entrapment can occur when part of a person's body gets caught between parts of the bed, such as in the space between the mattress and the side rail. This hazard can cause strangulation and death. Older people in hospitals and nursing homes, especially those who are frail, confused, restless, or who have uncontrollable body movement, are most vulnerable to entrapment.
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The guidance provides design recommendations for manufacturers of new hospital beds. It also gives suggestions to facilities with existing beds, including hospitals, nursing homes, and private residences, on ways to reduce entrapment risk.
Key body parts at risk of entrapment are the head, neck, and chest. Potential zones of entrapment in a hospital bed are
"While not all patients are at risk for an entrapment, and not all hospital beds pose a risk of entrapment, this new guidance will help ensure that new hospital beds are designed to reduce the potential for entrapment," says Larry Kessler, Sc.D., director of the Office of Science and Engineering Laboratories within the FDA's Center for Devices and Radiological Health. The guidance will also help caregivers identify entrapment risks that may exist with current hospital beds, adds Kessler.
The guidance results from the efforts of the Hospital Bed Safety Workgroup (HBSW). Formed in 1999, the HBSW is a partnership among the FDA, the Veterans Administration, other federal agencies, Health Canada's Medical Devices Bureau, national health care organizations and provider groups, patient advocacy groups, and medical bed and equipment manufacturers.
The FDA has received 691 reports of entrapment over a period of 21 years, from Jan. 1, 1985, to Jan. 1, 2006. The reports included 413 deaths, 120 nonfatal injuries, and 158 near-miss events where staff intervened to prevent serious injury.
See www.fda.gov/cdrh/beds/ for more information.
The FDA has approved RotaTeq, a live, oral vaccine for preventing rotavirus gastroenteritis in infants. It is the only vaccine approved in the United States that can help protect against this viral infection that can cause diarrhea, vomiting, fever, and dehydration.
Approved in February 2006, RotaTeq is a liquid vaccine that is given by mouth in three doses between 6 and 32 weeks of age. It can effectively prevent an illness that the Centers for Disease Control and Prevention (CDC) says affects almost all children within the first few years of life. The CDC estimates that rotavirus infection results in about 55,000 hospitalizations annually for infants and young children in this country.
In 1998, the FDA approved a different live vaccine against rotavirus that was later withdrawn from the market because of its association with an increased risk of intussusception, a rare and life-threatening type of blockage or twisting of the intestine. The risk of intussusception for RotaTeq was studied in a large trial of over 70,000 children. Half of those in the study received the vaccine, and the remaining half received an inactive pill (placebo). RotaTeq was not associated with either an increased risk of intussusception or an increased risk of other serious adverse events when compared to the placebo.
Safety of this vaccine, manufactured by Merck & Co. Inc. of Whitehouse Station, N.J., will be closely monitored in additional studies conducted after licensing.
The manufacturer of the antibiotic drug Tequin (gatifloxacin) has announced labeling changes based on continued reports of serious cases of low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia) in people taking the drug. Since the FDA approved Tequin in 1999, rare cases of life-threatening events have been reported around the world in people treated with the drug.
Tequin, made by Bristol-Myers Squibb Co., New York, is approved to treat people with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including urinary tract, kidney, and skin infections.
The labeling changes strengthen an existing warning on hypoglycemia and hyperglycemia, add a contraindication for use in people with diabetes, and provide information identifying other risk factors for developing low or high blood sugar, including advanced age, kidney malfunction, and taking glucose-altering medications while taking Tequin.
The FDA will continue monitoring Tequin's safety to ensure that its benefits outweigh the risks to people who take the drug.
The FDA has approved the first skin (transdermal) patch, called Emsam (selegiline), for treating major depression.
Emsam is a once-a-day patch that delivers selegiline, a monoamine oxidase inhibitor, or MAOI, through the skin and into the bloodstream. Its three layers consist of a backing, adhesive drug layer, and release liner that is placed against the skin.
"Emsam provides a significant advance," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, "because at least in its lowest dose, patients can use the drug without the usual dietary restrictions associated with these types of drugs known as MAO inhibitors." The lowest dose of the MAOI patch delivers 6 milligrams (mg) of the medication over a 24-hour period.
MAOIs usually require specific dietary restrictions because when combined with certain foods, they can cause a sudden, large increase in blood pressure, or hypertensive crisis, which can lead to a stroke and death. Symptoms of a hypertensive crisis include sudden severe headache, nausea, stiff neck, fast heartbeat or a change in the way the heart beats, sweating, or confusion. Patients who have these symptoms must get medical attention immediately.
The Emsam patch, which will be distributed by the New York-based Bristol-Myers Squibb, will be available in three sizes that deliver 6 mg, 9 mg, or 12 mg of selegiline over 24 hours.
The FDA has published draft guidance for food producers who work with fresh-cut fruits and vegetables, to minimize health hazards that may be introduced during processing.
Processing fruits and vegetables into fresh-cut produce increases the risk of bacterial contamination and growth. During processing, the natural exterior barrier of the produce is broken by peeling, slicing, coring, trimming, or mashing before being packaged for consumption. Examples of fresh-cut products are shredded lettuce, sliced tomatoes, raw vegetable salads, peeled baby carrots, broccoli florets, cauliflower florets, cut celery stalks, shredded cabbage, cut melons, sliced pineapple, and sectioned grapefruit.
The guidance discusses the production and harvesting of fresh produce and provides recommendations for fresh-cut processing.
Consumers can reduce their risk of illness from fresh-cut produce by following safe handling practices such as refrigerating the product after purchase; using only clean hands, utensils, or dishes in preparing the product; and discarding the product when the "use by" date has expired.
To find out more on how to safely handle food, see:
The FDA has approved Sutent (sunitinib), a new targeted anti-cancer medicine to treat patients with gastrointestinal stromal tumors (GIST), a rare stomach cancer, and advanced kidney cancer.
The approval of Sutent is a major step forward in making breakthrough treatments available for patients with rare and difficult-to-treat forms of cancer, says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "New targeted therapies such as Sutent are helping FDA expand options for patients for whom there are limited alternatives."
The drug's approval in January marks the first time the agency has approved a new oncology product for two indications simultaneously.
According to the American Cancer Society, about 5,000 cases of GIST and 32,000 new cases of advanced kidney cancer are diagnosed each year.
Sutent was approved for patients with GIST whose disease has progressed or who are unable to tolerate treatment with Gleevec, the current treatment for GIST. Early data showed that Sutent delayed the time it takes for tumors or new lesions to grow in patients with this rare stomach cancer.
The FDA also granted accelerated approval for Sutent in treating patients with advanced renal cell carcinoma (RCC). In contrast to the approval for GIST, which was based on the drug's ability to delay the growth of tumors, RCC approval was based on the drug's ability to reduce the size of tumors in patients.
Some common side effects reported with Sutent are diarrhea, skin discoloration, mouth irritation, weakness, and altered taste.
Sutent is distributed by Pfizer Labs of New York City.
Health and Human Services (HHS) Secretary Mike Leavitt and experts from the FDA announced in March 2006 the release of an opportunities list and the formation of a consortium to advance the FDA's Critical Path Initiative. The initiative is the FDA's premier effort to modernize medical product development so that new medical discoveries are brought to patients faster and at a lower cost.
The Critical Path Opportunities List outlines an initial 76 projects to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into treatments.
"This Opportunities List enhances the health and well-being of Americans by fostering strong, sustained scientific advances in medicine to better public health," Leavitt said in announcing the list.
The Predictive Safety Testing Consortium was formed as a partnership between the Critical Path Institute (C-Path) and five of America's largest pharmaceutical companies. The consortium will share laboratory methods and tests to better understand the safety and side effects of potential new drugs before they are tested in humans. The FDA will assist the consortium in an advisory capacity.
C-Path of Tucson, Ariz., was established in 2005 as an independent nonprofit research and education institute to facilitate collaboration among its founding partners: the FDA, The University of Arizona, and SRI International.
See www.fda.gov/oc/initiatives/criticalpath/ for more information.
The FDA has approved the first generic version of Flonase (fluticasone propionate), a drug that treats the nasal symptoms of seasonal and chronic allergies. The February 2006 generic approval gives Americans an additional, lower cost alternative when choosing prescription drug products.
Except for their price, which is much lower, generic drugs are in every way equivalent to their brand name counterparts, says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. Offering consumers a safe, effective, and reasonably priced choice "is an extremely important priority for FDA," according to Galson.
Fluticasone Propionate Nasal Spray contains a synthetic, trifluorinated corticosteroid with anti-inflammatory capability. Like other corticosteroids, the generic nasal spray does not have an immediate effect on allergic symptoms. A decrease in stuffiness, runniness, itching, and sneezing nasal symptoms was noted in some patients 12 hours after initial treatment.
Common side effects of the new nasal spray, manufactured by Roxane Laboratories of Columbus, Ohio, are headache, sore throat, and nosebleed.
In February 2006, the FDA ordered Biomedical Tissue Services Ltd. (BTS) of Fort Lee, N.J., a human tissue-recovery firm, and Michael Mastromarino, D.D.S., the company's chief executive officer and executive director of operations, to immediately cease all manufacturing operations. All tissue products initially recovered from human donors by BTS were recalled, and the FDA is carefully monitoring these recalls to account for all of the tissue distributed.
The FDA order to cease manufacturing and to retain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) requires BTS to suspend any and all manufacturing steps, including but not limited to, the recovery and shipment of HCT/Ps.
The agency's inspection of BTS uncovered serious violations of the regulations governing donor screening and record keeping practices, as well as failures to follow the company's standard operating procedures, failure to recover HCT/Ps in a manner that does not cause contamination or cross-contamination during recovery, and failure to adequately control environmental conditions.
Despite records maintaining otherwise, the firm had inadequately screened donors for risk factors for, or clinical evidence of, relevant communicable disease agents and diseases. The FDA also found numerous instances in which death certificates maintained in BTS' files were at variance with the death certificates the FDA obtained from the state where the death occurred.
After initially focusing efforts on assessing the safety of distributed tissues and on facilitating the appropriate recalls, the FDA has determined that these violations, because of their seriousness, constitute a health danger.
The FDA continues to investigate BTS' activities and to work cooperatively with tissue processors and appropriate federal, state, and local authorities, and will take further actions as needed.
Go to www.fda.gov/cber/compl/bts013106.htm for a copy of the BTS order.
Consumers will now have help in making dietary choices based on a "whole grain" term that is consistent and reliable. The FDA has issued draft guidance for manufacturers on what the term may include.
"The food label is the best tool we have to help consumers choose a healthy diet, which includes whole grain products," says Robert E. Brackett, Ph.D., director of the FDA's Center for Food Safety and Applied Nutrition.
The draft guidance clarifies that the agency considers whole grain to include cereal grains that consist of the intact, ground, cracked, or flaked fruit of the grains whose principal components--the starchy endosperm, germ, and bran--are present in the same relative proportions as they exist in the intact grain. Such grains may include barley, buckwheat, bulgur, corn, millet, rice, rye, oats, sorghum, wheat, and wild rice.
The draft guidance states that although rolled and "quick oats" can be called whole grains because they contain all of their bran, germ, and endosperm, other widely used food products may not meet the whole grain definition. For example, the FDA does not consider products derived from soybeans (legumes), sunflower seeds (oilseeds), and arrowroot (roots) as whole grains. And the draft guidance specifically recommends that pizza be labeled only as "whole grain" or "whole wheat" when its crust is made entirely from whole grain flours or whole wheat flour.
This guidance is part of the federal government's long-standing effort to advise consumers about healthy food choices. The 2005 Dietary Guidelines for Americans recommend that half of the grain that consumers eat should be whole grains. Consumers, the guidelines say, should eat at least 3 ounces of whole-grain cereals, breads, crackers, rice, or pasta every day. One ounce is about one slice of bread, one cup of breakfast cereal, or 1/2 cup of cooked rice or pasta. Consumers also should look to see that grains such as wheat, rice, oats, or corn are referred to as "whole" in the list of ingredients.
Currently, manufacturers also can make factual statements about whole grains on food labels such as "10 grams of whole grains" or "1/2 ounce of whole grains."
The FDA has approved Eraxis (anidulafungin) to treat certain infections caused by Candida, a yeast-like fungus that can cause serious infections in hospitalized patients or patients with compromised immune systems.
"This product offers a new alternative therapy for several types of infections associated with Candida," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "It is a helpful addition to the available antifungal medications that can be used in the treatment of these potentially serious fungal conditions."
Eraxis, a new molecular entity never marketed in the United States, is an antifungal drug that is administered intravenously. It is used to treat Candida infections in the esophagus (candidiasis), bloodstream (candidemia), and other forms of Candida infections, including abdominal abscesses and inflammation of the lining of the abdominal cavity (peritonitis).
Eraxis was generally well-tolerated in clinical studies. The most commonly reported adverse events were mild diarrhea, mild elevations in laboratory tests of liver enzymes, and headache. Some patients experienced infusion-related reactions, most of which were mild. In a few patients with significant underlying medical conditions who were on multiple medications, there were reports of serious liver abnormalities.
Eraxis is manufactured by New York City-based Pfizer Inc.
The FDA has approved Erbitux (cetuximab) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that cannot be removed by surgery.
The March 2006 approval is the first drug treatment for head and neck cancer that has shown a survival benefit. At the same time, Erbitux was also approved for use alone to treat patients whose head and neck cancer has spread, despite the use of standard chemotherapy.
"Patients suffering from all forms of cancer have a common goal--to treat the disease and prolong life," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer. The approval of Erbitux monotherapy to shrink tumors in patients with metastatic disease who no longer respond to other forms of treatment is also important. Patients need as many effective treatment options as possible."
Erbitux, which received a priority review, is the first drug approved to treat head and neck cancer since methotrexate became available in the 1950s. Approval of Erbitux in combination with radiation therapy was based on a study that showed it prolonged survival by 20 months compared with radiation treatment alone.
Approval of Erbitux monotherapy was based on evidence of tumor shrinkage in 13 percent of patients, lasting an average of six months. Standard cancer statistics databases estimate that there are about 29,000 new cases of head and neck cancer diagnosed every year in the United States.
The safety and effectiveness of Erbitux was established in two studies. The randomized clinical trial of 424 patients using Erbitux in combination with radiation therapy showed a survival time of 49 months versus 29.3 months on radiation therapy alone. In addition, delay in tumor growth was observed with the use of Erbitux and radiation, compared to radiation alone.
Since tumor growth is associated with pain and with difficulties swallowing, speaking, and eating, control of tumor growth as long as possible is important for a patient's well-being. In a second trial of 103 patients with recurrent or metastatic SCCHN, Erbitux helped to shrink the patients' tumors after the tumors no longer responded to platinum-based therapy, the current standard treatment for patients with this difficult-to-treat disease.
Erbitux is manufactured by ImClone Systems Inc., Branchburg, N.J., and will be distributed and marketed by Bristol-Myers Squibb Co., Princeton, N.J.
The FDA has approved Amitiza (lubiprostone), the first drug of its chemical type, for the treatment of chronic constipation of unknown cause in adults. Approved in January 2006, Amitiza is available as capsules for use by adults to treat "idiopathic" constipation cases not caused by other diseases or by use of medications.
Chronic idiopathic constipation is generally defined as infrequent and difficult passage of stool. It's one of the most common disorders suffered by Americans. This condition affects women more often than men and also affects people older than 65 more frequently. Symptoms of chronic idiopathic constipation are abdominal pain and discomfort, bloating, straining, and hard stools.
Amitiza increases the intestinal fluid secretion, which helps ease the passage of stool and helps alleviate symptoms. The FDA based its decision to approve Amitiza on results from two clinical trials, which were conducted in patients with, on average, less than three spontaneous bowel movements a week with symptoms of constipation for at least six months before entry into the studies.
The studies demonstrated that subjects treated with Amitiza had a higher frequency of bowel movements in the first week than the subjects who received a phony pill. In both studies, results similar to those in Week 1 were also observed in Weeks 2, 3, and 4 of therapy.
The most common adverse events reported in the trials included headache, nausea, diarrhea, abdominal pain, and distension. Whether these events are related to the drug is not known at this time. Amitiza should be taken twice a day with food. Physicians and patients should periodically assess the need for continued treatment.
Amitiza is marketed by Sucampo Pharmaceuticals Inc., Bethesda, Md., and by Takeda Pharmaceuticals America, Lincolnshire, Ill.