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FDA | FDA Centennial
Acting FDA Commissioner Andrew C. von Eschenbach, M.D. (left) presents U.S. Health and Human Services Secretary Mike Leavitt with the Commissioner's Special Citation at the FDA's centennial celebration of the Pure Food and Drugs Act of 1906.
More than 200 people, including former Commissioners of Food and Drugs, representatives of consumer and trade groups, FDA employees, and descendants of Dr. Harvey W. Wiley, the scientist whose early support of food and drug regulations earned him the title of "Father of the Pure Food and Drugs Act," attended the June 30 event at the Harvey W. Wiley Federal Building in College Park, Md. The Centennial event also was telecast to all FDA employees nationwide.
The FDA and the U.S. Environmental Protection Agency want consumers to know that a joint advisory concerning mercury in fish issued in 2004 remains current.
The advisory titled "What You Need to Know About Mercury in Fish and Shellfish" contains recommendations for women who might become pregnant, women who are pregnant, nursing mothers, and young children.
The FDA and the EPA say that women and young children should include fish and shellfish as a regular part of their diet. Both are an important part of a healthy diet and can contribute to heart health and to children's proper growth and development. Nearly all fish and shellfish, however, contain traces of mercury.
Women and young children can receive the benefits of eating fish and shellfish while reducing their exposure to the harmful effects of mercury by following three recommendations:
The FDA continues to test fish and shellfish for mercury and will update the advisory if there is a significant change in the underlying science regarding the risks from methylmercury or the benefits from eating fish.
See www.cfsan.fda.gov/~dms/admehg3.html for more information.
The FDA has approved the first generic version of Zocor (simvastatin), an important step in the agency's effort to increase the availability of lower-cost generic medications.
Simvastatin is recommended for use, along with a diet restricted in saturated fat and cholesterol, to treat high cholesterol and to reduce the amount of certain fatty substances in the blood such as triglycerides and other lipids.
Zocor is a member of a drug class known as statins. According to the research firm IMS Health, statins accounted for $16 billion in U.S. sales in 2005. Zocor was the second most widely prescribed statin.
"Simvastatin is a widely-used cholesterol lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease," says Gary J. Buehler, director of the FDA's Office of Generic Drugs.
Simvastatin tablets are manufactured by IVAX Pharmaceuticals Inc. of Northvale, N.J., and by Ranbaxy Pharmaceuticals Inc., Princeton, N.J.
The FDA has also recently approved the first generic version of Zoloft tablets (sertraline), as well as a liquid concentrate (sertraline hydrochloride) version of the product.
Sertraline tablets are indicated for the treatment of major depressive disorder (MDD) in adults, and the liquid concentrate is approved for the treatment of MDD and some anxiety-related disorders. In 2005, Zoloft was the sixth highest-selling brand-name drug in the United States, with retail sales totaling $2.6 billion.
Other first generic products recently approved by the FDA are
The economic benefits of the FDA's generic drug approval program are significant because generics can cost a fraction of the price of brand-name drugs and generic drugs represent about two-thirds of total prescription doses sold in the United States in 2004, according to IMS data on U.S. retail sales.
Anthelios SX, a sunscreen to be sold over-the-counter (OTC) for the prevention of sunburn and for protection against ultraviolet B (UVB) and ultraviolet A (UVA) rays, has been approved by the FDA.
"While this product provides protection from harmful UVA and UVB rays, FDA continues to recommend that in addition to using a sunscreen, consumers protect themselves from sun exposure by limiting time in the sun and wearing protective clothing," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research.
Anthelios SX, which has a sun protection factor (SPF) of 15, is a sunscreen product that contains a combination of three active ingredients. One of the ingredients is a new molecular entity (NME), ecamsule. Ecamsule has not been marketed in the United States, but has been marketed in Europe and Canada as Mexoryl SX since 1993. The other two active ingredients, avobenzone and octocrylene, are generally recognized as safe and effective under the current OTC monograph for sunscreens.
The safety and efficacy data for Anthelios SX included information from 28 studies involving more than 2,500 people, ranging in age from 6 months to more than 65 years. Side effects reported during clinical studies were infrequent and not serious. The most common side effects in patients were acne, dermatitis, dry skin, eczema, abnormal redness, itching, skin discomfort, and sunburn.
The product will be distributed by La Roche-Posay.
The FDA has approved Elaprase (idursulfase), the first product for the treatment of Hunter syndrome (Mucopolysaccharidosis II, or MPS II), a rare inherited disease that can lead to premature death. Elaprase is a new molecular entity, which is an active ingredient never before marketed in the United States.
Hunter syndrome, which usually becomes apparent in children ages 1 to 3 years, is a disease in which the person's body is defective in producing a chemical called iduronate-2-sulfatase. This chemical is needed to adequately break down complex sugars produced in the body. Symptoms include growth delay, joint stiffness, and coarsening of facial features. In severe cases, patients experience respiratory and cardiac problems, enlargement of the liver and spleen, neurological deficits, and death.
Approved in July 2006, Elaprase was designated as an orphan product by the FDA. Orphan products are generally developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first sponsor who obtains marketing approval for a designated orphan product. Hunter syndrome is diagnosed in about 1 out of every 65,000 to 132,000 births.
Elaprase was approved after a randomized, double-blind, placebo-controlled study of 96 patients with Hunter syndrome showed that the treated participants had an improved capacity to walk.
Because of the potential for severe hypersensitivity reactions, appropriate medical support should be readily available when Elaprase is administered. Patients and their physicians are encouraged to participate in a voluntary Hunter Outcome Survey that has been established to monitor and evaluate the safety and effects of long-term treatment with Elaprase.
Elaprase is manufactured by Shire Human Genetic Therapies Inc., Cambridge, Mass.
The FDA is warning consumers and health care providers not to use a product called bismacine, also known as chromacine. The agency is investigating one report of a death and several reports of injury related to the administration of the substance.
Bismacine, an injectable product prepared by druggists, has been used by some to treat Lyme disease. But bismacine has not been approved by the FDA to treat Lyme disease or any other disease or condition.
Bismacine is not a pharmaceutical. It is suggested or administered by "alternative health" practitioners or by people claiming to be medical doctors. Bismacine contains high amounts of bismuth, a heavy metal used in some medications taken by mouth to treat a bacterium that can cause stomach ulcers (Helicobacter pylori). It is not approved for use by injection.
On April 20, 2006, one person died as a result of treatment with bismacine, and on March 29, 2005, another person was hospitalized after receiving a bismacine treatment. Other serious adverse events have been reported. Possible effects of bismuth poisoning include cardiovascular collapse and kidney failure.
The FDA is advising consumers and health care providers not to use bismacine. Individuals who believe they have suffered adverse events from receiving bismacine may wish to seek medical attention. The agency is evaluating the product suppliers and will take additional action as appropriate.
Adverse reactions experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm; by phone (800) FDA-1088 (332-1088); by returning FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm; by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787; or by fax (800) FDA-0178 (332-0178).
The FDA has approved Exelon (rivastigmine tartrate) for the treatment of mild-to-moderate dementia associated with Parkinson's disease, a disorder of the central nervous system. Exelon was approved previously for the treatment of mild-to-moderate dementia of the Alzheimer's type.
"It's been recognized for almost a decade that the dementia of patients with Parkinson's disease differs from the dementia of patients with Alzheimer's," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "But until now, there has been no treatment that has been shown to be effective specifically for the dementia associated with Parkinson's disease. Today's approval of Exelon helps to fill this medical need."
It is estimated that about 0.2 percent to 0.5 percent of people older than 65 are affected by Parkinson's dementia and experience such symptoms as impairments in executive function, memory, and attention. The approval of Exelon for the treatment of Parkinson's dementia is based on the results of a randomized, placebo-controlled clinical study with 541 patients who showed symptoms of mild-to-moderate dementia two years or later after their diagnosis for Parkinson's disease. At the end of the 24-week trial, the condition of the Exelon-treated patients, as shown on a scale that measures mental processes, was significantly better than the condition of the patients on placebo.
The use of Exelon has been associated with significant gastrointestinal adverse reactions. In clinical trials, 47 percent of the patients treated with the drug developed nausea, and others on high doses of Exelon experienced significant weight loss. Other common adverse events reported by patients on Exelon include vomiting, anorexia, dyspepsia, and loss of strength (asthenia). In some patients with Parkinson's disease, treatment with Exelon was associated with a worsening of tremor.
Exelon is manufactured by Novartis Pharmaceutical Corp. in East Hanover, N.J.
The FDA has approved Lucentis (ranibizumab injection) for the treatment of people with wet (neovascular) age-related macular degeneration (AMD). Lucentis is the first treatment that, when taken monthly, can maintain the vision of more than 90 percent of people with this type of AMD, studies show.
Lucentis is a new molecular entity, meaning it contains an active substance that has never before been approved for marketing in any form in the United States. It is the first FDA-approved product to provide prescription information in a new, easy-to-read format that the agency unveiled in January 2006 for prescription drug package inserts.
"This approval is of great importance for the 155,000 Americans who are diagnosed each year with AMD, a common cause of severe and irreversible vision loss in older adults," says Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D.
AMD is a retinal disease and a major cause of blindness in individuals older than 55. Wet AMD, which accounts for 10 percent of all AMD, is responsible for 80 percent of the associated vision loss.
Lucentis, a biologic product, is designed to block the growth of abnormal leaky blood vessels, which cause the vision loss in wet AMD. Lucentis is administered by injection into the eye. It was shown to be safe and effective in three multicenter, randomized studies of people representative of the population usually affected with AMD. In clinical trials, nearly 95 percent of the participants who received a monthly injection maintained their vision at 12 months, compared with about 60 percent of patients who received the control treatment. About one-third of the trial participants had improved vision at 12 months.
The most commonly reported side effects included red eye (conjunctival hemorrhage), eye pain, small specks in vision (floaters), increased eye pressure, and inflammation of the eye. Serious side effects, which were rare and often related to the injection procedure, included severe inflammation of the interior of the eye (endophthalmitis), intraocular inflammation, retinal detachment, retinal tear, increased eye pressure, and traumatic cataract.
Lucentis is manufactured by Genentech Inc. in South San Francisco, Calif.
The FDA and the Institute for Safe Medication Practices (ISMP) have launched a nationwide education campaign for health professionals aimed at reducing medication mix-ups and mistakes caused by the use of unclear medical abbreviations.
"Some abbreviations, symbols and dose designations are frequently misinterpreted and lead to mistakes that result in patient harm," says Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "This joint campaign will promote safe practices among those who communicate medical information to help avoid serious and even potentially fatal consequences of medication errors."
According to the Institute of Medicine (IOM) of the National Academies, more than 7,000 deaths a year are attributable to medication errors.
The educational campaign focuses on eliminating the use of potentially confusing abbreviations by health care professionals, medical students, medical writers, the pharmaceutical industry, and FDA employees.
"We recommend that ISMP's list of abbreviations, symbols and dose designations most often associated with medication errors be considered whenever medical information is communicated," says the ISMP's President Michael Cohen.
For campaign materials and more information, see www.fda.gov/cder/drug/MedErrors and www.ismp.org/tools/abbreviations.
A new HIV protease inhibitor, Prezista (darunavir), has been approved for adults whose HIV infection has not responded to treatment with other antiretroviral drugs. Prezista is approved to be used with a low dose of ritonavir and with other active anti-HIV agents. Ritonavir, a protease inhibitor approved in 1996, slows the breakdown of Prezista in the body, thereby increasing the concentration of Prezista in the person's system.
"This approval offers new hope to HIV patients who too often urgently need new therapies in order to maintain their health," says Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "This drug is not a cure, but when combined with other standard therapies, it presents one more major step in our effort to help patients combat the effects of the disease."
The accelerated approval was based on evidence from two randomized, controlled studies comparing the safety and effectiveness of a Prezista-ritonavir combination with other ritonavir-boosted protease inhibitor combinations. Participants in both arms of these trials also used other anti-HIV agents (nucleoside reverse transcriptase inhibitors), with or without enfuvirtide, which inhibits the virus from entering the cell.
In these studies, participants on a Prezista-ritonavir combination experienced higher rates of reduction of their HIV viral load than those on other ritonavir-boosted protease inhibitor combinations. Seventy percent of those treated with the Prezista-ritonavir combination achieved a response, improving the treatment outcome, compared with 21 percent in a control group at six months.
The most common side effects reported by those on the Prezista-ritonavir regimen included diarrhea, nausea, and headache. About 7 percent of people on this combination therapy experienced skin rashes.
Prezista is manufactured for Tibotec Inc., a division of Ortho Biotech Products L.P., Raritan, N.J., by JOLL, Gurabo, Puerto Rico.
The FDA has approved the first drug for seasonal affective disorder (SAD). Wellbutrin XL (bupropion HCL extended-release tablets) previously was approved to treat major depressive disorder. It's now also approved to prevent major depressive episodes in people with a history of SAD.
SAD is characterized by recurrent major depressive episodes that usually coincide with the seasonal decrease of daylight during autumn and winter. The depressive episodes can last up to six months. Although patients with SAD may have depressive episodes during other times of the year, the diagnosis of SAD requires that the number of seasonal episodes substantially outnumber the non-seasonal episodes during the individual's lifetime.
A major depressive episode is defined as the presence of five or more of the nine core symptoms of major depression for at least two weeks. The symptoms include: depressed mood, loss of interest, weight loss or other weight or appetite changes, insomnia or hypersomnia, agitation or psychomotor retardation, fatigue, feelings of worthlessness or guilt, impaired concentration, and suicidal thinking or behavior. One of the five symptoms must be either depressed mood or loss of interest in activities. Another essential feature of major depression is the presence of significant distress or impairment in social, occupational, or other important areas of functioning. A seasonal major depressive episode is defined by the identical features.
The effectiveness of Wellbutrin XL for the prevention of SAD episodes was established in three double-blind, placebo-controlled trials in adults with a history of major depressive disorder in autumn and winter. In these trials, the percentage of people who were depression-free at the end of treatment was significantly higher for those on Wellbutrin XL than for those on placebo. For all three studies combined, the overall rate of patients depression free at the end of treatment was 84 percent for those on Wellbutrin XL, compared with 72 percent for those on placebo.
Wellbutrin XL's labeling includes a "black box" warning concerning the increased risk of suicidal thoughts and behavior in pediatric patients treated with antidepressant medications. As with all antidepressants, Wellbutrin XL has a Medication Guide advising that pediatric patients on antidepressants should be watched closely for these serious symptoms. It is important to note that Wellbutrin XL is indicated only for patients who meet strict diagnostic criteria of seasonal major depressive episodes. Wellbutrin XL is manufactured by GlaxoSmithKline, Research Triangle Park, N.C.
The FDA has approved a combination of Hycamtin (topotecan hydrochloride) and cisplatin for use as the first drug treatment for women with late-stage cancer of the cervix when surgery or radiation therapy is unlikely to be effective. The approval is a new indication for Hycamtin, which was approved in 1996 for treating ovarian cancer and in 1998 for small cell lung cancer.
In the United States, there are an estimated 10,000 new cases of cervical cancer and about 3,700 related deaths each year. "We are making great strides in the fight against cervical cancer, a disease that, world wide, is the second most common cancer in women," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "This course of drug therapy is a potentially life-prolonging option for thousands of women."
The combination of Hycamtin and cisplatin is specifically indicated for women with Stage IVB (incurable), recurrent, or persistent cancer of the cervix that spreads to other organs and is not likely to respond to treatment with surgery or radiation.
Hycamtin is associated with a significant risk of neutropenia (a drop in white blood cell count), a condition which makes it more difficult for the body to fight infections. Serious side effects also include thrombocytopenia, a decrease in blood platelets that can lead to excessive bleeding and anemia. Less serious side effects include nausea and vomiting. The incidences of neutropenia, anemia, and thrombocytopenia were significantly increased among patients receiving the combination treatment, compared with those receiving cisplatin alone, as were nausea and vomiting, inflammation of a mucous membrane (mucositis), rash, and liver toxicity.
Hycamtin is manufactured by GlaxoSmithKline, Research Triangle Park, N.C.
The FDA has completed its safety assessment of the antibiotic Ketek (telithromycin) and is advising health practitioners and patients to be aware of rare but potentially serious health risks.
Ketek is indicated for the treatment of acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia, including pneumonia caused by resistant strep infections. The drug has been associated with rare cases of serious liver injury and liver failure, with four reported deaths and one liver transplant after its use. The manufacturer, sanofi-aventis U.S. LLC of Bridgewater, N.J., is revising the drug labeling to address this safety concern.
Although it is difficult to determine the exact frequency of Ketek-associated adverse events on the basis of the FDA's reporting systems, the agency has concluded that the drug's benefit to patients for the approved indications outweighs its risk, including the rare risk of liver failure, and supports its continued availability.
"We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function." The signs and symptoms of liver failure include fatigue, malaise, loss of appetite, nausea, yellow skin, and dark-colored urine.
The FDA will continue to evaluate Ketek-associated safety issues and will take further action, if warranted.
Baxter Healthcare Corp. and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. The company and executives have agreed to stop manufacturing and distributing all models of the Colleague Volumetric Infusion Pump and the Syndeo Patient Controlled Analgesic Syringe Pump within the United States until manufacturing deficiencies are corrected and until the devices are made in compliance with the FDA's current good manufacturing practice requirements and quality system regulation for devices.
Infusion pumps are electronic devices used to control the delivery of solutions and medications to patients. They are used in situations in which medication must be given intravenously or through other routes for an extended period of time.
"Infusion pumps deliver life-saving drugs and nutrition to thousands of critically ill patients," says Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "But if they don't work properly, patients are put at risk. Baxter has clearly had significant problems with some of its infusion pumps. With this action, Baxter has agreed to correct those problems. FDA's goal is to see that the necessary corrections are made, that the public health is protected, and that users have access to safe and effective pumps."
Under the consent decree, the FDA will allow the firm to continue to provide routine maintenance, or to replace components, parts, or accessories, for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before Oct. 12, 2005. Baxter also is required to submit to the FDA an acceptable detailed corrective action plan to bring these infusion pumps currently in use in the United States into compliance with the Federal Food, Drug, and Cosmetic Act.