The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.
The agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed.
In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action.
“Physicians need to be aware of the risk of overdose when prescribing these drugs. They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug’s label,” said Janet Woodcock, M.D, director of the FDA’s Center for Drug Evaluation and Research. “Prescribers and patients should be aware of propoxyphene’s potential risks when used at doses higher than those recommended. Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy.”
To further evaluate the safety of propoxyphene, the FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.
Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or if the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions, the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.
Also today, the FDA denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene. The agency said in its response that despite the FDA’s serious concerns about propoxyphene, the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time. The FDA also noted that it plans to further evaluate the safety of propoxyphene and will take additional regulatory action if necessary. Details of this decision can be found at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm.
Propoxyphene has been on the market since 1957. It is a widely prescribed member of a group of drugs known as opioids and is used as a treatment for mild to moderate pain.
The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.
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Tuesday, July 7, 2009
FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene
CDC Launches New Environmental Public Health Tracking Network
The Centers for Disease Control and Prevention announced today the launch of the Web-based Environmental Public Health Tracking Network, a surveillance tool that scientists, health professionals, and -- for the first time -- members of the public can use to track environmental exposures and chronic health conditions.
"The ability to examine many data sets together for the first time has already resulted in faster responses to environmental health issues. We believe the Tracking Network holds the potential to shed new light on some of our biggest environmental health questions," said Howard Frumkin, M.D., M.P.H., DrPh., director, of CDC's National Center for Environmental Health.
The web-based tool unites vital environmental information from across the country, including air and water pollutants and information for some chronic conditions, including asthma, cancer, childhood lead poisoning and heart disease into one resource.
While scientists know exposures such as air particle pollution and lead contribute to illnesses, many environmental and health connections remain unproven since detailed health and environmental data existed in separate silos until now.
"The Tracking Network is the foundation we need to make better environmental health decisions and help prevent chronic illnesses, such as asthma, cancer, and heart disease," said Michael McGeehin, Ph.D., director, Division of Environmental Hazard and Health Effects of CDC's National Center for Environmental Health.
CDC funds projects in California, Connecticut, Florida, Maine, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Utah, Washington, Wisconsin, and New York City.
To date, their projects have led to 73 public health actions to control potential illnesses from environmental exposures. For example, the Utah Department of Health received a call from a citizen concerned about cases of cancer in his neighborhood. In the past, a similar call would have prompted a study that would have taken up to a year to complete, with most of that time spent waiting for data. In less than a day, the Utah Tracking Program was able to let this resident know that the likelihood of cancer in his area was no greater than in the state as a whole.
Massachusetts ranks third in the United States for prevalence of asthma. When Massachusetts Tracking staff conducted asthma surveillance and indoor quality assessments in schools, a significant association between mold/moisture and the prevalence of asthma was found. Based on tracking data, Massachusetts staff are working with school officials to correct mold/moisture problems and to enact policy changes for reducing mold and moisture in schools.
In March 2009, CDC received additional funding from Congress to expand environmental public health tracking to five more locations. Awards will be made and announced later this summer. Over time, CDC hopes to expand the Tracking Network across all 50 states, and track additional environmental hazards and health conditions to build a more complete picture of environmental public health.
CDC's Tracking Network is the result of collaboration with 17 local and state health departments; federal partners, including the National Aeronautics and Space Administration, the National Cancer Institute, the U.S. Environmental Protection Agency and the U.S. Geological Survey; and organizations including the American Public Health Association, Association of State and Territorial Health Officials, Council of State and Territorial Epidemiologists, National Association of County and City Health Officials, National Environmental Health Association, National Association of Health Data Organizations and the National Association for Public Health Statistics and Information Systems.
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Thursday, October 16, 2008
FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:
* Drug labeling, including patient labeling, professional labeling, and patient package inserts;
* Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
* A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug's safety, efficacy, or optimal use;
* Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial's purpose, who may participate, locations, and useful phone numbers;
* Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
* Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
* Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
* Regulations and guidance documents;
* Consumer information about using medications safely and disposing of unused medicines;
* Instructions how to report problems to the FDA through its MedWatch program;
* Consumer articles on drug safety; and
* The FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.
"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."
Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.
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