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
'"/>




Page: 1 2

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:
TAG: FDA Requests Label Change for All Sleep Disorder Drug Products

(Date:8/27/2014)... play a key role in inflaming blood vessels and ... study at UCLA demonstrates that they may also contribute ... the small blood vessels in the lungs. , Using ... mimicking part of the main protein in high-density lipoprotein ... production of oxidized lipids in pulmonary hypertension. They also ...
(Date:8/27/2014)... 27, 2014 The federal judge overseeing ... has extended the deadline for plaintiffs to enroll in ... Order issued by U.S. District Judge David Katz of ... in the DePuy ASR Settlement Program must do so ... ASR Hip Implant Products Liability Litigation – MDL 2197) ...
(Date:8/27/2014)... Ticket Down is a dependable source for authentic ... Miami. The Brazilian national soccer team will tangle with ... Life Stadium in Miami Gardens, Florida. The two South ... Cup earlier this year when Brazil got the 2-1 win, ... Federation announced earlier this week that Neymar would return from ...
(Date:8/27/2014)... 27, 2014 Connor Sports has ... World Cup in Spain at the Barcelona, Bilbao, Gran ... FIBA Equipment & Venue Centre Partner since 1994 and Official ... six courts will bear the Connor Sports logo and tagline ... globe on the ESPN broadcasts of the FIBA World Cup. ...
(Date:8/27/2014)... Philadelphia, PA (PRWEB) August 27, 2014 ... co-winner of this year’s 87th Annual Scripps National Spelling ... 2014 for a tour of internationally renowned Wills Eye ... would like to be an ophthalmologist one day. , ... simulated eye surgery and the latest hi-tech visual diagnostic ...
Breaking Medicine News(10 mins):Health News:Protein in 'good cholesterol' may be a key to treating pulmonary hypertension 2Health News:DePuy ASR Settlement Enrollment Deadline Extended Until September 30, 2014, Bernstein Liebhard LLP Reports 2Health News:DePuy ASR Settlement Enrollment Deadline Extended Until September 30, 2014, Bernstein Liebhard LLP Reports 3Health News:Brazil vs. Colombia Tickets in Miami, FL: Ticket Down Cuts Ticket Prices on World Cup Rematch of Colombia vs. Brazil at Sun Life Stadium in Miami on Sept. 5th 2Health News:Brazil vs. Colombia Tickets in Miami, FL: Ticket Down Cuts Ticket Prices on World Cup Rematch of Colombia vs. Brazil at Sun Life Stadium in Miami on Sept. 5th 3Health News:Connor Sports® Provides Six Custom Courts for 2014 FIBA World Cup - Time-Lapse Video of FIBA Courts Production Released 2Health News:Connor Sports® Provides Six Custom Courts for 2014 FIBA World Cup - Time-Lapse Video of FIBA Courts Production Released 3Health News:Scripps National Spelling Bee Co-Champion and Aspiring Ophthalmologist Coming to Wills Eye Hospital in Philadelphia 2
... nursing,leader Sally Watkins, PhD(c), MS, RN, has been ... by the Washington State Nurses,Association (WSNA), the State,s ... "We are very fortunate to have in Sally ... patient and nurse advocate," said WSNA Executive,Director Judy ...
... in a mid-August edition of Circulation: Journal of the America ... healthy eating habits, it can strongly influence their heart disease ... Turku Coronary Risk Factor Intervention Project have landmark implications on ... study, a childs fat intake, primarily reduction in intake of ...
... industry is riding the green wave back into public ... our growing energy needs. But even as the industry ... it is bound by a global energy landscapefrom solar ... marketplace. , Veteran New York Times energy reporter ...
... Sept. 11 (HealthDay News) -- Carvedilol, a newer member of the ... heart failure, did not help children with the condition, a new ... of it -- was almost exactly the same for 103 young ... who got a placebo. , "Heart failure in children is both ...
... resulted in a cancer diagnosis among a population of ... not find cancer often had multiple biopsies in the ... , While PSA (prostate-specific antigen) tests have become ... what actually determines the presence of prostate cancer. Nonetheless, ...
... A new American Cancer Society study finds having at least ... risk of cancer death. The study finds higher education levels ... white men, and white women. The difference in mortality for ... years of education and those with more than 12 years. ...
Cached Medicine News:Health News:New Director of Nursing Practice Named for Nurses Association 2Health News:Children who learn heart healthy eating habits lower heart disease risk 2Health News:Children who learn heart healthy eating habits lower heart disease risk 3Health News:Trade-offs reveal no clear favorites in alternative energy market 2Health News:Beta Blocker Doesn't Help Children With Heart Failure 2Health News:Other highlights in the September 11 JNCI 2Health News:Other highlights in the September 11 JNCI 3Health News:Study links education to risk of cancer death 2Health News:Study links education to risk of cancer death 3
(Date:8/27/2014)... BOSTON , Aug. 27, 2014  Columbia Laboratories, ... Company"), a provider of pharmaceutical development, clinical trial manufacturing, ... industry, today announced that it will participate at the ... Investment Conference, to be held in New ... conference at 11:15am on September 9, 2014 at the ...
(Date:8/27/2014)... China , Aug. 27, 2014  Amerigen Pharmaceuticals ... ("Menovo") today announced they had entered into a collaboration ... the United States market. Under ... jointly develop products for Amerigen to commercialize in ... responsible for manufacturing API and finished product whereas Amerigen ...
(Date:8/27/2014)... 2014 /CNW/ - Covalon Technologies Ltd. (the "Company" or "Covalon") ... financial results for its third quarter of fiscal 2014: ... , Revenue of $1,291,378, a 13% decrease over the ... for the quarter of $240,156 compared to net income of ... For the nine months ended June 30, 2014: ...
Breaking Medicine Technology:Amerigen Pharmaceuticals Limited and the Ningbo Menovo Pharmaceutical Co., Ltd, today announced they had entered into a collaboration agreement regarding the development of generic pharmaceuticals, primarily targeting the United States market 2Covalon Announces Third Quarter Results 2Covalon Announces Third Quarter Results 3
... has two sensors and a black band ... optimal placement in relation to the UES., ... pH monitoring. , ,Alpine's VersaFlex catheters ... the market (4.7 French), and are the ...
... pH catheters are efficient, economical, eliminate ... greater patient comfort during the test ... systems have been designed to use ... accurate room-temperature calibration. The temperature correction ...
FLEXILOG spare part....
FLEXILOG spare part....
Medicine Products: