Navigation Links
FDA Requests Label Change for All Sleep Disorder Drug Products

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep,// strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

· Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.

· Complex sleep-related behaviors, which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

· FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedat ive-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

Source-Bio-Bio Technology
RM
'"/>




Related medicine news :

1. Canadian Street Prostitutes Requests Protection
2. New Zealand Requests Details from Britain about ‘Black Sheep
3. Patients Requests for Antidepressants can Influence Physician Evaluation of Depression
4. Cyberkinetics Requests FDA to Sell Nerve Growth Stimulation System
5. GlaxoSmithKline - Changes Lamictal(R) Label Appearance and Packaging
6. Impotence Drugs Ordered by FDA to have Label Change
7. The Dangers Of Vitamin A To Pregnant Women To Be Included On Label
8. Identifying What Consumers Look For On Food Stuff Labels
9. Canada Introduces Mandatory Nutrition Labeling
10. Look For Food Allergens On The Product Label.
11. Nutritional Labels are the order of the day!
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids ... Milford, NJ. This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, ... run is geared towards children of all ages; it is a non-competitive, non-timed event, ...
(Date:10/13/2017)... ... , ... “The Journey: From the Mountains to the Mission Field”: the story ... the Philippines. “The Journey: From the Mountains to the Mission Field” is the creation ... has taught all ages and currently teaches a class of ladies at her church, ...
(Date:10/12/2017)... ... ... Planet Fitness, one of the largest and fastest growing franchisors and operators ... location in Covington, LA at 401 N. U.S. Highway 190, in January of 2018. ... in the Holiday Square shopping center. Its location allows it to serve both Covington ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... Leading pediatric ... peers in Washington, D.C., for the 49th Congress of the International Society of ... Vice President of the Center for Cancer and Blood Disorders at Children’s ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... Sept. 25, 2017  EpiVax, Inc., a leader ... and immune-engineering today announced the launch of EpiVax ... of personalized therapeutic cancer vaccines. EpiVax has provided ... access to enabling technologies to the new precision ... lead EpiVax Oncology as Chief Executive Officer. Gad ...
(Date:9/22/2017)... SAN DIEGO , Sept. 22, 2017 ... ll medical device is now successfully helping those with ... Union. Fibromyalgia diagnosed Amanda in ... getting dressed and washing my hair, experiencing no sleep ... body in painful spasm… I cannot recommend [the AVACEN ...
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017  PMD ... OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... strategic hub service that expedites and streamlines patient and ... Spiro PD 2.0, and wellness management services.  ... medical device used to measure lung function for a ...
Breaking Medicine Technology: