[ad_1]
SPRING MONEY, Md., April 30, 2019 / PRNewswire / – The US Food and Drug Administration today announced that its agency was demanding a new framed warning – the most important warning of the agency – on some insomnia medications prescription to ensure that patients and their health care professionals have the information they need to consider use. of these drugs. The boxed warning follows several reports of rare but serious injuries and deaths resulting from various complex sleep behaviors after taking these medications. These complex sleep behaviors may include sleepwalking, drowsiness, and other non-awake activities, such as using a stove in an unsafe manner. The new warnings will be needed for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist).
"We recognize that millions of Americans suffer from insomnia and rely on these medications to help them sleep better at night.Although these incidents are rare, they are serious and it is important that patients and health professionals are aware of the risks. " occur after the first dose of these sleeping pills or after a longer period of treatment, and may occur in patients with no history of these behaviors and even at the lowest recommended doses, "said the Acting FDA Commissioner Ned Sharpless, MD "Today's action is an important step in our ongoing efforts to bring more attention to these critical safety issues, as well as our ongoing commitment to ensuring that patients and healthcare professionals have the necessary information to make informed treatment decisions. "
In addition to the boxed warning, the agency requires the addition of a contraindication for not using these drugs in patients who had an episode of complex sleep behaviors after having them taken. The badociation between these medications and the complex behaviors of sleep is already included in the label, which has been continuously updated to take into account other safety issues as they have been identified. The warnings and contraindications framed are intended to reinforce the warning and reflect the risk of serious injury and death.
In a communication on drug safety published today, the FDA makes recommendations for the benefit of health professionals and patients, as well as a summary of the data that led to these warnings.
"We have been closely monitoring the safety profile of these drugs since their approval, when our ongoing safety surveillance recently revealed the risk of more serious injuries and deaths in patients taking these medications and who behaved differently. complex sleep, we determined that it was necessary stronger measures to inform the public, "said Janet Woodbad, M.D., director of the FDA's Center for Drug Evaluation and Research. "We will continue to monitor and evaluate the risks badociated with insomnia medications and to communicate with the public or consider other measures, if appropriate."
Following a new safety review based on recent reports of adverse events and other data sources, the FDA has determined that, although rare and complex sleep behaviors badociated specifically with the use of eszopiclone, zaleplon and zolpidem (all sleep aids) resulted in serious injury and death. Specifically, the FDA reviewed 66 cases reported to the FDA adverse event reporting system or found in the medical literature, in which patients were engaged in activities while they were not fully awake. , such as sleepwalking or driving while driving, resulting in serious injury or death after insomnia. drugs eszopiclone, zaleplon or zolpidem. The 46 non-fatal serious injury reports included accidental overdoses, falls, burns, near drowning, exposure to extremely cold temperatures resulting in the loss of almost one limb of death, injuries such as gunshot wounds and alleged suicide attempts. The 20 reported deaths were due to carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal collisions with a driver and apparent suicide.
In order to be approved, medications for insomnia must be accompanied by a drug guide indicating the uses and risks of the drug. Patients should review this information whenever they receive a refill of their medication because the information may change. Health care professionals should not prescribe eszopiclone, zaleplon or zolpidem for patients who have a history of complex sleep behavior after taking these insomnia medications. Patients should be informed that rare and serious injuries, even death, are possible. Patients should stop taking these medications and immediately contact their health care professional if they find that they have engaged in activities while they are not fully awake or they do not remember the activities performed while they were taking the medication.
Health care professionals and patients should report adverse effects of eszopiclone, zaleplon, zolpidem, or other medications to the FDA MedWatch program.
For more information:
The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.
Media requests: Sandy Walsh, 301-796-4669, [email protected]
Consumer Inquiries: 888-INFO-FDA
SOURCE US Food and Drug Administration
Related Links
http://www.fda.gov
Source link
