Tag Drug

Food and drug administration Approves Botox for Crow’s Feet

13 September, 16:36, by kealsimpson Tags: , , , , , ,

News Picture: FDA Approves Botox for Crow's Feet

WEDNESDAY, Sept. eleven (HealthDay Information) — Adults bothered by the appearance of crow’s toes — traces at the outdoors corners of the eyes — have a new therapy choice.

The U.S. Meals and Drug Administration on Wednesday accepted the use of Botox Cosmetic for short-term enhancement of moderate to severe crow’s feet.

Botox Cosmetic (onabotulinum toxin A) has been accredited in the United States considering that 2002 to treat frown lines amongst the eyebrows. It operates to make wrinkles less prominent by trying to keep facial muscle tissue from tightening, according to an Food and drug administration information launch.

“This extra indicator will give people with a new Fda-accepted treatment selection for people seeking a smoother physical appearance by briefly minimizing the look of crow’s feet at the sides of the eyes,” Dr. Susan Walker, director of the division of dermatology and dental goods in the FDA’s Middle for Drug Evaluation and Analysis, mentioned in the news release.

Botox Beauty is provided by intramuscular injection. Treatment method for frown traces (officially identified as glabellar lines) and crow’s feet (lateral canthal traces) is presented at the same time.

The therapy underwent two scientific trials to build its basic safety and usefulness for bettering crow’s toes. In all, 833 adults with moderate to severe traces have been randomly assigned to get Botox Beauty or an inactive placebo. Individuals in the Botox Cosmetic group showed higher advancement in their visual appeal.

Eyelid edema — in which the eyelids are swollen and have excessive fluid — was the most typical facet impact described.

Botox Cosmetic is produced by Allergan Inc., primarily based in Irvine, Calif.

– Lisa Esposito

Copyright © 2013 HealthDay. All legal rights reserved.

Resource: U.S. Meals and Drug Administration, information launch, Sept. eleven, 2013

MedicineNet Pores and skin Standard

Food and drug administration Warns of Unusual Skin Reactions to Acetaminophen

03 August, 14:32, by kealsimpson Tags: , , , , , , ,

News Picture: FDA Warns of Rare Skin Reactions to Acetaminophen

FRIDAY, Aug. two (HealthDay News) — The widely utilised painkiller acetaminophen, ideal acknowledged as Tylenol, can result in rare but significant pores and skin reactions and a warning about this threat will be additional to item labels, the U.S. Food and Drug Administration mentioned Thursday.

Acetaminophen is also often used in mixture with other medicines, such as opioids for soreness and medications to deal with colds, coughs, allergy, headache and sleeping issues.

In accordance to the Fda, acetaminophen can bring about 3 serious pores and skin reactions. Two of them — Stevens-Johnson Syndrome and poisonous epidermal necrolysis — normally demand hospitalization and can be deadly.

The reactions normally start with flu-like signs and symptoms followed by rash, blistering and comprehensive harm to the pores and skin surface area. Recovery can consider weeks or months, and attainable problems include scarring, pores and skin coloration modifications, blindness and damage to interior organs.

A 3rd skin response that can be trigger by acetaminophen is named acute generalized exanthematous pustulosis. It normally resolves in two months right after a affected person stops taking acetaminophen.

People who create a rash or other skin reaction even though using acetaminophen ought to end taking the drug and seek out immediate medical focus, the Fda said.

“This new info is not intended to worry shoppers or health care experts, nor is it meant to inspire them to select other medications,” Dr. Sharon Hertz, deputy director of FDA’s Division of Anesthesia, Analgesia and Dependancy, mentioned in an agency news release. “However, it is incredibly essential that people recognize and respond rapidly to the initial signs and symptoms of these exceptional, but severe, facet results, which are perhaps lethal.”

The Food and drug administration explained that a warning about these skin reactions will be added to the labels of all prescription medications that contains acetaminophen, and the agency will work with manufacturers to have warnings extra to the labels of non-prescription medications that have acetaminophen.

The FDA’s selection to insert warnings about attainable skin reactions to products with acetaminophen is primarily based on an examination of knowledge showing that there have been 107 instances of acetaminophen-connected skin reactions in the U.S. in between 1969 and 2012. These instances resulted in sixty seven hospitalizations and twelve fatalities.

Other drugs utilized to deal with fever and pain, this sort of as nonsteroidal anti-inflammatory medications (NSAIDs) including ibuprofen and naproxen, already have warnings about the risk of significant skin reactions.

Two a long time in the past, the Fda took measures to minimize the threat of liver damage from acetaminophen. The company asked manufacturers of prescription merchandise to limit acetaminophen to 325 milligrams for every pill or capsule and essential all prescription acetaminophen goods to contain a boxed warning about liver injury chance.

Hertz pressured that the, “FDA’s actions need to be considered inside the context of the thousands and thousands who, more than generations, have benefited from acetaminophen. Even so, given the severity of the danger, it is essential for patients and overall health treatment companies to be conscious of it.”

– Robert Preidt

Copyright © 2013 HealthDay. All legal rights reserved.

Resource: U.S. Food and Drug Administration, information launch, Aug. 1, 2013

MedicineNet Skin Common

Research Finds No Tie Between Pimples Drug Accutane and Crohn’s, Colitis

22 February, 17:03, by kealsimpson Tags: , , , , , , ,

News Picture: Study Finds No Tie Between Acne Drug Accutane and Crohn's, Colitis

WEDNESDAY, Feb. 20 (HealthDay News) — A new examine counters the idea that the prescription pimples drug Accutane raises the danger of Crohn’s disease or colitis in females.

The study of more than 45,000 women identified no these kinds of link amongst Accutane (isotretinoin) use and these sicknesses, which are collectively recognized as inflammatory bowel ailment (IBD).

One particular specialist not linked to the review known as it a “welcome review.”

“There has been a great deal of speculation and even litigation that Accutane triggers inflammatory bowel illness,” said Dr. Michele Green, a dermatologist at Lenox Hill Healthcare facility in New York Metropolis.

“Dermatologists have been discouraged from employing Accutane and the makers of Accutane have discontinued their creation owing to countless lawsuits,” she famous, but “this study as soon as once more highlights the basic safety of Accutane.”

Ulcerative colitis and Crohn’s illness are the most widespread kinds of IBD, a group of issues in which the intestines become inflamed. Signs consist of abdominal soreness, diarrhea, reduction of appetite, unexplained excess weight loss, bleeding from the rectum, fever, joint discomfort and pores and skin issues.

In this study, released in the February situation of JAMA Dermatology, scientists in comparison virtually two,two hundred women of reproductive age who had IBD from another group of more than 43,000 women with no IBD.

Only ten (.46 p.c) of the IBD individuals and 191 (.44 per cent) of individuals in the management group had used Accutane — so there was essentially no variation.

The findings “do not recommend an increase in danger” for IBD between people who use Accutane, concluded Mahyar Etminan, of the College of British Columbia in Canada, and colleagues.

Extreme pimples can cause significant emotional distress for youngsters and teens. The study benefits show that worries about IBD ought to not avoid medical professionals should not avert from prescribing Accutane to these individuals, the scientists concluded in a journal news launch.

Eco-friendly agreed. “Unfortunately, Accutane has presently been demonized and individuals are considerably less most likely to acquire this drug simply because of the undeserved unfavorable reputation,” she said.

An additional dermatology skilled explained you will find just no organization proof to hyperlink Accutane and bowel disorders.

“This is the third review released analyzing the association amongst isotretinoin and inflammatory ailment. The two prior scientific studies confirmed conflicting results,” said Dr. Joshua Zeichner, an assistant professor of dermatology at the Icahn University of Medication at Mount Sinai, in New York Town.

In accordance to Zeichner, “One [prior research] confirmed no association and the other showed a small affiliation between isotretinoin [Accutane] and ulcerative colitis only. This research looks exclusively at adult ladies and does not demonstrate an affiliation among the drug and inflammatory bowel illness.”

Overall, he stated, “the information from these 3 research are not ample to demonstrate a causal relationship amongst isotretinoin use and inflammatory bowel condition.” He mentioned the existence of any hyperlink amongst acne breakouts and IBD is also far from established.

However, Accutane is not appropriate for use by particular sufferers, especially amid girls of childbearing age, because its use has been linked to a larger incidence of start flaws, Zeichner observed.

“A woman who is expecting, &#thirteen
breast-feeding or not compliant with utilizing two types of beginning handle are not candidates,” for making use of the acne drug, mentioned Zeichner, who is also director of Beauty &amp Clinical Research at the Mount Sinai Medical Centre.

He extra that individuals with a historical past of severe depression are also recommended to stay away from Accutane, as are individuals with liver ailment or substantial cholesterol.

– Robert Preidt

Copyright © 2013 HealthDay. All legal rights reserved.

Sources: Michele Environmentally friendly, M.D., dermatologist, Lenox Hill Hospital, New York Town Joshua Zeichner, M.D., director, Beauty &amp Clinical Study at the Mount Sinai Medical Middle, and assistant professor, dermatology, Icahn College of Medication at Mount Sinai, New York City JAMA Dermatology, information launch, Feb. 20, 2013

MedicineNet Pores and skin Basic