FDA Announces Enhanced Warnings for Immediate-Release Opiod Pain Medications Related to Risks of Miuse, Abuse, Addiction, Overdose and Death
Food & Drug Administration
New safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use
In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications. This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.
“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, M.D., FDA commissioner. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”
Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others. Prescription opioids are divided into two main categories – IR products, usually intended for use every four to six hours; and extended-release/long-acting (ER/LA) products, which are primarily intended to be taken once or twice a day, depending on the individual product and patient. Certain opioids, such as methadone and buprenorphine, are also used as a form of treatment for opioid addiction, and in combination with behavioral therapy and counseling, are known as medication-assisted treatment, or MAT.
The updated indication clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.
As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts. NOWS may occur in a newborn exposed to opioid drugs for a prolonged period while in utero.
In 2013, the FDA required class-wide labeling changes for ER/LA opioid analgesics that included modifications to the products’ indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the serious risks associated with these drugs. Today, the FDA is requiring similar changes to the labeling of IR opioid analgesics.
“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products,” said Douglas Throckmorton, M.D., deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research. “Today, we have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications.”
Additionally, the FDA is requiring updated labeling for all opioids (both ER/LA and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome. Updated labeling will also include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) and decreased sex hormone levels (androgen deficiency). These labeling changes will also make it clear that these negative outcomes can occur whether a patient is taking an opioid to treat pain or if the product is being used for MAT. Today, the FDA issued a Drug Safety Communication outlining these risks.
“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids.”
The FDA is also aware of, and carefully reviewing, available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once a review of all available scientific information is completed, the FDA will take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.
These actions are the latest examples of the agency’s commitment to combat this public health crisis and its profound impact on individuals, families and communities across our country. Health and Human Services Secretary Sylvia M. Burwell has made addressing opioid misuse, addiction and overdose a priority. Other work on this important issue is underway within HHS. The evidence-based HHS-wide opioid initiative focuses on three priority areas: informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose) and expanding access to and the use of MAT to treat opioid use disorder.
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.
ITA: News Releases & Documents
International Trade Administration
SAN JUAN, Puerto Rico. – US Customs and Border Protection (CBP) agriculture specialists discovered a new pest found for the first time in the nation.
On January 4, 2016, while inspecting a shipment of cut flowers from Ecuador at the Luis Munoz Marin Air Cargo facilities in Puerto Rico, a CBP Agriculture Specialist intercepted an uncommon pest. The insect was identified on March 21, 2016 by US Department of Agriculture (USDA) as Prairiana sp. (Cicadellidae), considered an actionable pest and “First Time in Nation” interception.
The insect was found on Hydrangea sp., a species of flowering plants. This insect is an actionable pest and it is the first time it has been found at a United States ports of entry.Prairiana sp. (Cicadellidae),
CBP Agriculture Specialists issued an Emergency Action Notification and the shipment was destroyed at a CBP/USDA approved facility.
“CBP Agriculture specialists have an important mission in safeguarding the nation’s agriculture”, said Sonja Cruz-Fidalgo, San Juan Supervisory Operations Manager – Agriculture. “This first in port interception demonstrates the vigilance of the agriculture specialists in Puerto Rico and their dedication to detect and prevent foreign invasive plants and plant pests from entering through our ports of entry.”
CBP Agriculture specialists work closely with Animal Plant Health Inspection Services – Plant Protection & Quarantine to protect our nation’s agriculture resources against the introduction of foreign plant pests and animal diseases. Detecting pests, evaluating their risk and implementing actions to prevent their propagation are necessary steps taken by the federal government to protect local agriculture.
CBP Agriculture specialists have extensive training and experience in the biological sciences and agricultural inspection. Their duties include inspecting tens of thousands of international air passengers and air and sea cargo that arrive into the United States each day. Approximately 4,664 pest interceptions were submitted to USDA at ports of entry in the San Juan Office of Field Operations during Fiscal Year 2015.
FTC Testifies on Efforts to Protect Privacy and Security of Consumer Health Information
Federal Maritime Commission
In testimony before Congress today, the Federal Trade Commission outlined its work to protect consumers in the growing area of health information technology.
Testifying on behalf of the Commission, Jessica Rich, Director of the FTC’s Bureau of Consumer Protection, highlighted the FTC’s efforts to protect the privacy and data security of consumer health information, particularly in areas where health information is being collected, used, and shared outside of doctors’ offices or other traditional medical contexts.
The testimony before the Subcommittees on Information Technology and Health, Benefits and Administrative Rules of the House Committee on Oversight and Government Reform provided background on FTC law enforcement efforts, policy work and consumer and business education programs related to health information technology.
Specifically, the testimony highlighted a number of cases brought by the Commission using its authority under the FTC Act, including against a medical billing company that deceived consumers about how information collected from them would be used, as well as cases relating to the unlawful data security practices of companies that manage consumers’ sensitive health information.
The testimony noted various policy initiatives designed to promote privacy and data security in the health information technology area, including an FTC seminar on consumer generated health information, a staff report on the Internet of Things, and collaboration with other federal agencies on policy initiatives related to health information technology issues.
In addition, the testimony highlighted the Commission’s ongoing efforts to provide education to consumers and businesses about issues in the health information technology area, including customized advice for victims of medical identity theft, and work to provide businesses with useful guidance on how to reduce security risks by starting with smart data security practices.
The Commission vote approving the testimony and its inclusion in the formal record was 4-0.
FDA Proposes Ban on Most Powdered Medical Gloves
Food & Drug Administration
Today (March 21), the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.
The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health."
Powder is sometimes added to gloves to help make it easier to put them on and take them off; however, powdered gloves are dangerous for a variety of reasons. In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions. Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.
As these risks cannot be corrected through new or updated labeling, the FDA is moving forward with the proposal to ban these products, which – if finalized – would ultimately remove them from the marketplace completely.
In making the determination that these products are dangerous and present an unreasonable and substantial risk, the FDA considered all available evidence, which included a thorough review of the available scientific literature and comments received on a February 2011 Federal Register Notice. In addition, given the critical role medical gloves play in protecting patients and health care providers, the FDA also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage and the economic impact of a ban would not be significant. The ban is also not likely to impact medical practice, because many non-powdered protective glove options are currently available.
The FDA has determined that the banning standard would not apply to powdered radiographic protection gloves. The agency is not aware of any powdered radiographic protection gloves that are currently on the market. Non-powdered surgeon gloves and non-powdered patient examination gloves will also not be included in the ban and will remain Class I medical devices. Therefore, the FDA is also proposing amendments to their classification regulations to clarify that they apply only to non-powdered gloves.
The proposed rule is available online at www.regulations.gov for public comment for 90 days.
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.
United States and Phillipines Strengthen Engagement on Trade
Office of the United States Trade Representative
Washington, D.C. -- The United States and the Philippines today held a meeting under their Trade and Investment Framework Agreement (TIFA), and agreed to expanded engagement in coming months. The meeting, which were chaired by Director Christine Brown and Philippine Undersecretary of Trade Ceferino Rodolfo, included Department of Labor and Employment Secretary Rosalinda Baldoz and other senior Philippine and U.S. officials from the trade, agriculture, customs, and intellectual property agencies.small-, and medium-sized enterprises participation in international trade. They agreed to work closely together to advance the trade and investment agenda for ASEAN, which the Philippines will host in 2017, including on the new U.S.-ASEAN Trade Workshops agreed by Ministers at the U.S.-ASEAN TIFA meeting held in San Francisco last month.
Background
The United States and the Philippines have had a close economic relationship for more than a century. Total goods trade between the United States and the Philippines has continued to grow, reaching more than $18 billion last year, up 41 percent since 2009. Services trade also is growing rapidly and exceeded $6.8 billion in 2014, also up 60 percent from 2009.
Philadelphia CBP Intercepts New Destructive Invader on Costa Rican Pineapples
U.S. Customs & Border Protection
PHILADELPHIA — The U.S. Department of Agriculture (USDA) confirmed today that a long horned beetle that U.S. Customs and Border Protection (CBP) agriculture specialists intercepted in a shipment of Costa Rican pineapples is the first recorded find of this species in the United States.
CBP discovered the beetle January 29 in a container of 1,575 cases of fresh pineapples. CBP secured the pineapples shipment for fumigation, and submitted the pest specimen to the local USDA entomologist for identification.
The entomologist identified the species as Ayriclytus macilentus of the Cerambycidae family, a species known to occur in Panama, Nicaragua, Colombia, and Costa Rica, and advised CBP that the insect is a pest new to the United States. The national pest identification database confirmed this claim today.
According to the USDA, longhorn beetles pose a significant threat to coniferous and deciduous forests and kills live trees.
“Intercepting destructive insect invaders at our nation’s borders, and before they can threaten our agriculture industries, is of paramount importance to Customs and Border Protection,” said Susan Stranieri, CBP Port Director for the Area Port of Philadelphia. “CBP agriculture specialists take their job very serious, and recording these ‘first in nation’ insect interceptions are significant discoveries.”
CBP agriculture specialists have extensive training and experience in the biological sciences, risk analysis, and in imported agriculture inspection techniques. CBP agriculture specialists are the first line of defense in the protection of U.S. agriculture, forest and livestock industries from exotic destructive plant pests and animal diseases.
On a typical day nationally, CBP agriculture specialists inspect over 1 million people as well as air and sea cargo imported to the United States and intercept 4,447 prohibited meat, plant materials or animal products, including 425 agriculture pests and diseases. Read more about CBP’s agriculture protection mission.
Hate Robocall Scams? The FTC Does, Too
Federal Trade Commission
An illegal robocall could be a scam. Learn what the FTC is doing to stop illegal robocalls, what to do if you get one, and how to block the number.
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