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 ... 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 ... 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 ... 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 ... 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 ... 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 ... 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 ... 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 ... September 25, 2013 General Health Information Technology, Food and Drug Administration 0 0 Comment Read More »
