FDA restricts use of cough and cold medicines with codeine or hydrocodone for kids The U.S. Food and Drug Administration (FDA) said today that cough and cold medicines containing codeine and hydrocodone should not be prescribed to children and adolescents because of serious safety risks posed by the opioid ingredients. The FDA also announced that such products will now be required to carry "boxed warnings" – the FDA’s strongest warning – that highlight the risks misuse, abuse, addiction, overdose, death, and slowed or difficult breathing. According to the FDA, it is taking this action after an extensive review that determined the risks associated with these medicines outweigh their benefits in patients younger than 18. Click here for more information. January 30, 2018 General Food and Drug Administration, Opioids, Pediatrics 0 0 Comment Read More »
FDA wants opioid pulled from market due to risk of abuse Last week, the U.S. Food and Drug Administration (FDA) requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is concerned that the benefits of the drug may no longer outweigh its risks. This is the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. The FDA’s decision is based on a review of all available data and follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks. Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012 in an attempt to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. Postmarketing data has shown, however, a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.” The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval. In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product. For more information about preventing opioid abuse, see the California Medical Association's safe prescribing resource page at www.cmanet.org/safe-prescribing. June 21, 2017 General Food and Drug Administration, Prescription Drugs, Drug Abuse, Opioids 0 0 Comment Read More »
FDA bans use of powdered medical gloves The U.S. Food and Drug Administration (FDA) recently issued a final rule that bans the use of powdered medical gloves. The ban took effect January 18, 2017, after the FDA determined that powdered surgeons' gloves, powdered patient examination gloves and absorbable powder for lubricating surgeons' gloves present an unreasonable and substantial risk of illness or injury to both patients and health care personnel. After a thorough review of all currently available information, the FDA concluded that the use of powder on medical gloves present numerous risks, including sensitization to natural rubber latex allergens, surgical complications related to peritoneal adhesions and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder. The FDA also cited additional risks of inflammation, granulomas and respiratory allergic reactions related to the use of powdered gloves. It concluded that these risks cannot be corrected or eliminated by labeling or a change in labeling and consequently, is banning its use. To read the FDA's rule, click here. For more information, see CMA On-Call documents #6307, "Injury and Illness Prevention Programs," and #3666, "Occupational Illness and Injury." CMA On-Call documents are available free to members in CMA's online health law library at www.cmanet.org/cma-on-call. Nonmembers can purchase documents for $2 per page. May 22, 2017 General Food and Drug Administration, Office Safety 0 0 Comment Read More »
FDA adds boxed warning to hepatitis C drugs The U.S. Food and Drug Administration (FDA) is warning of serious, potentially life-threatening risks for patients infected with hepatitis B virus who are being treated with certain direct-acting antiviral medicines for hepatitis C virus (HCV). According to the FDA, direct-acting antiviral medicines for hepatitis C virus can reactivate hepatitis B virus. In a few cases, hepatitis B reactivation in patients treated with direct-acting antivirals resulted in serious liver problems or death. As a result, FDA is requiring a boxed warning about the risk of hepatitis B reactivation to be added to the drug label, directing health care professionals to screen and monitor for hepatitis B reactivation in all patients being treated with direct-acting antivirals. Direct-acting antiviral medicines are used to treat chronic hepatitis C infection, an infection that can last a lifetime. These medicines reduce the amount of the virus in the body by preventing it from multiplying, and in most cases, they cure hepatitis C. Without treatment, HCV can lead to serious liver problems including cirrhosis, liver cancer, and death. More than 3 million people in the U.S. have hepatitis C, which is spread through blood and can necessitate a liver transplant. For more information, see the FDA's Drug Safety Communication. October 14, 2016 General Food and Drug Administration, Public Health 0 0 Comment Read More »
FDA warns of risks from mixing opioids with anti-anxiety drugs The Food and Drug Administration (FDA) announced last week it will require tough new warning labels that spell out the increased risks of combining anti-anxiety (benzodiazepines) with prescription opioids. Nearly 400 opioid products will now be required to carry "boxed warnings" – the FDA’s strongest warning – that highlight the risks from combined use, which include extreme sleepiness, respiratory depression, coma and death. The new warning labels are one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reducing prescription opioid misuse, abuse and overdose, while still providing patients in pain access to effective and appropriate pain management. The FDA is also urging physicians to be extra careful when prescribing medication regimens that mix the two classes of drugs, and prescribe opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options have been ineffective. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or [central nervous system] depressants more generally – together outweigh these serious risks," said FDA Commissioner Robert Califf, M.D. According to the FDA, if these medicines are prescribed together, physicians should limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Physicians should also warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms. Click here to see the drug and safety communication from the FDA. September 12, 2016 General Food and Drug Administration, Opioids, Drug Prescribing, Prescription Drugs 0 0 Comment Read More »
FDA lifts ban on blood donation by gay and bisexual men The U.S. Food and Drug Administration (FDA) has released final rules that ease restrictions on blood donations by gay and bisexual men. The new rule allows gay and bisexual men to donate blood if they have not had sex with a man for one year. Previously, the FDA banned all blood donations from men who have had sex with another man since 1977. The previous FDA regulations stipulated that gay men were "deferred as blood donors ... because as a group, [they were] at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion." The rule had not been updated since 1992. In making this new rule, the FDA considered a shorter deferral period, but opted for the one-year delay because there is a body of research on this time frame. According to the FDA, studies have not yet evaluated the safety of shorter deferral periods. “Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge," Peter Marks, M.D., Ph.D., deputy director of the FDA’s Center for Biologics Evaluation and Research, wrote in a statement. In October 2012, the California Medical Association (CMA) House of Delegates adopted Resolution 108-12, which supports the use of rational, scientifically based deferral periods for blood donations, applied based on level of risk rather than on sexual orientation. The resolution called on CMA to oppose the FDA-mandated lifetime deferral on blood donations from men who have sex with men. For more information on the new rule, click here. Contact: Samantha Pellon, (916) 551-2887 or spellon@cmanet.org. January 15, 2016 General California Phyhsician's Legal Handbook, Food and Drug Administration, Blood Donation 0 0 Comment Read More »
House passes bill to increase funding for medical research and speed FDA approvals Last week, the U.S. House of Representatives voted overwhelmingly (344-77) to pass a bill known as the "21st Century Cures Act," which would boost federal funding for medical research and speed up Food and Drug Administration (FDA) approvals for many new drugs and medical devices. The bill, HR 6, will give $8.75 billion to the National Institutes of Health (NIH) for research and another $550 million to the FDA over the next five years. A scaled-down bill has been introduced in the U.S. Senate and there are hopes that it will pass by the end of the year. The bill will remove barriers to increased research collaboration, modernize the clinical trial process (including patient registries), provide incentives for the development of drugs for rare diseases, create an Innovation Research Fund, and assist the biomedical infrastructure to help the future development of drugs and devices. It would be funded by selling oil from the nation’s strategic petroleum reserves. One goal of the bill is to speed up the FDA approval process. Drug companies have long complained the FDA approval process is too rigorous and too slow, preventing them from bringing some less-profitable drugs to market. Critics of the bill say the FDA currently has strict safety standards for drug approval and this bill will loosen those standards. One of the direct results of the bill would be to allow more flexibility in clinical trials in the development of new antibiotics. Legislators are convinced that the reliance on old drugs and the lack of new drugs have created a plague of untreatable "superbugs." The bill would also change the FDA approval process for medical devices, redefining the evidence that can be submitted for consideration to include patient medical histories and articles published in peer-reviewed journals. The measure has generally drawn praise from the medical community and patient groups. However, it has drawn criticism from some consumer advocates that say FDA approval changes would threaten to lower safety standards. The California Medical Association (CMA) has been closely following this bill and will continue to work with the American Medical Association and Members of Congress as the bill moves forward. In addition to the main provisions discussed above, there are a number of other health care related provisions in this bill. A provision of particular concern is a one that would allow Medicare Part D plans to create barriers for physicians when prescribing controlled substances to patients. CMA also worked to insert a provision that requires Medicare to provide comparable cost information to seniors for the same services depending on the site of service. CMA has been critical of the fact that Medicare pays as much as three times more for the same service when it is delivered in the hospital versus a physician’s office. July 29, 2015 General Food and Drug Administration, Research and Experimental Medicine, Federal Legislation, Medical Devices, Public Health 0 0 Comment Read More »
FDA issues final guidance on mobile medical apps The U.S. Food and Drug Administration (FDA) has issued final guidance for developers of mobile medical applications (apps) or software programs that run on mobile communication devices and perform the same functions as traditional medical devices. According to an agency press release, the FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended. "Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it," the FDA wrote in its opinion. "Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly," the release said. The FDA is focusing its oversight on mobile medical apps that: are intended to be used as an accessory to a regulated medical device - for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or transform a mobile platform into a regulated medical device - for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack. Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices. The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years. For more information: Mobile Medical Applications Final Guidance Consumer Update: Keeping Up with Progress in Mobile Medical Apps Mobile Medical Applications Web Page September 25, 2013 General Health Information Technology, Food and Drug Administration 0 0 Comment Read More »
