FDA

White House Announces National Action Plan to Combat Antibiotic-Resistant Bacteria

White House Announces National Action Plan to Combat Antibiotic-Resistant

It has been reported that the White House on March 27 unveiled its National Action Plan for combating antibiotic-resistant bacteria. As per sources, the new five-year plan worth $1.2 billion would include both human and animal health factors.

Earlier in September 2014, President Obama issued an executive order to fight Antibiotic-Resistant Bacteria that led to the creation of an interagency taskforce, led by the Secretaries of Agriculture, Defense and Health and Human Services.

Margaret Hamburg Supports US FDA Drug Approval Standards

Margaret Hamburg Supports US FDA Drug Approval Standards

The US Food and Drug Administration's drug approval standards have been defended by Dr. Margaret Hamburg, who has served as Commissioner of the FDA since May 2009. Hamburg defended the standards in her final speech after six years as commissioner against critics seeking weaker regulatory standards.

"The great leaps forward in evidence-based medicine of last 50 years have come in large part as a result of high standards for product approval that Congress put in place after series of disasters involving unsafe and ineffective medical products", said Hamburg, 59, said on Friday at a National Press Club lunch in Washington, DC.

Olympus issues New Instructions for cleaning Device linked to Superbugs

Olympus issues New Instructions for cleaning Device linked to Superbugs

Olympus Corp is the largest maker of a medical device at the center of recent United States superbug outbreaks. On Thursday Olympus announced that new steps are needed to clean its medical device. The company has issued new cleaning instructions and said that health providers should implement them as soon as possible.

In a 13-page letter, the company said that a small-bristle brush is required to clean potentially deadly bacteria from the devices. According to the company, the brush would be shipped no later than May 8. The device maker didn't announce whether it is safe to use the devices, called duodenoscopes, until the hospitals receive the brush. The company said that health provider can clean the device in accordance with the old instructions.

FDA Permits Drug for Treatment of Inhalational Anthrax Cases

FDA Permits Drug for Treatment of Inhalational Anthrax Cases

The US Food and Drug Administration has given green signal to Anthrasil, a drug meant to treat patients infected by inhalational anthrax.

The FDA said the drug officially named as Anthrax Immune Globulin Intravenous (Human) will be used for treatment in combination with currently used antibacterial drugs. It is said that when patient starts exhibiting symptoms of the disease then it is considered to be too late.

But Anthrasil has been developed in such a way it would help anthrax victims even after they have started displaying symptoms. Inhalational anthrax is a rare form of the disease, which can happen after exposure to infected animals or through contaminated animal products.

Aurora Products issues recall of Walnut, Trail Mix Blend Products from US retail stores

Aurora Products issues recall of Walnut, Trail Mix Blend Products from US retail

The US food and Drug Administration (FDA) has announced that Aurora Products is recalling its products distributed through retail stores in the U. S., Canada and in Bermuda.

The company based in Orange, Conn is recalling products from sold at Giant food stores and Stop & Shop stores due to possible contamination with Salmonella.

The potential Salmonella contamination was discovered during routine testing by an outside company. The company contacted the FDA after finding the presence of Salmonella in a container of natural walnut products.

Salmonella contamination can lead to serious and fatal infections. Elderly people, children younger than age 5, and immune-compromised, i. e. people with compromised immune systems are at greatest risk of serious infection.

Most widely used herbicide could probably cause cancer

Most widely used herbicide could probably cause cancer

According to the World Health Organization, the herbicide glyphosate probably leads to cancer. The herbicide is usually sold under brand name Roundup by Monsanto. The WHO’s International Agency for Research on Cancer included the most glyphosate to its Group 2A list as ‘possibly carcinogenic’ to humans.

Monsanto, a publicly traded multinational agrochemical and agricultural biotechnology corporation, produces Roundup. The organization was not happy with the finding; it even criticized the matter. The organization said that all labeled uses of glyphosate cause no harm to human health. It also said that one of the largest human health databases also supports the safety claims related to the herbicide.

Breo Ellipta receives Mixed Views from FDA Panel

Breo Ellipta receives Mixed Views from FDA Panel

An FDA review panel has found that an asthma treatment co-developed by GlaxoSmithKline and Theravance is safe and effective in treating adults, but not adolescents.

Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) has received FDA panel's support to be used as once-daily inhaled treatment for the asthma patients aged 18 years and older, by a 16-4 vote.

But at the same time, the panel has voted against the use of asthma drug for treating patients aged between 12 and 17 years, with the panel voting 2 in favor and 18 against.

Breo is administered with the Ellipta dry powder inhaler device. It is a fixed-dose combination of the inhaled corticosteroid FF and the long-acting beta2-agonist VI.

FDA declares GMO Apples and Potatoes Safe

FDA declares GMO Apples and Potatoes Safe

The Food and Drug Administration (FDA) on Friday has declared that the genetically engineered non-browning apples and bruise-resistant potatoes are as safe and nutritious as their conventional counterparts.

Recently, the Department of Agriculture has approved the apples and potatoes for commercial planting. This department looks mainly at whether the crops would pose a threat to other plants and the FDA review looks at food safety.

The specialty of the so-called Arctic apples, which are developed by British Columbia-based Okanagan Specialty Fruits, is that they don't turn brown when sliced or bruised, which could result into less wastage of fruit and would make sliced apples more appealing.

FDA panel says Glaxo Asthma Drug safe for Adults

FDA panel says Glaxo Asthma Drug safe for Adults

On Thursday, an advisory panel to the United States Food and Drug Administration stated that British multinational pharmaceutical company GlaxoSmithKline Plc's asthma drug to treat chronic breathing problems is safe for adults. The panel also warned that the drug is not effective for adolescents with asthma.

According to reports, the panel voted 16-4. As per panel, the drug should be approved for once daily treatment of asthma in patients 18 years and older. The panel also voted 19-1 and concluded that drug will not be approved for children aged 12 to 17. Glaxo, which is headquartered in Brentford, licensed the product from Theravance Inc in 2002.

Trader Joe's Recalls Walnuts due to Salmonella Risk

Trader Joe's Recalls Walnuts due to Salmonella Risk

The US Food and Drug Administration, on Tuesday, announced that Trader Joe’s has voluntarily recalled the packages of raw walnuts due to the risk of Salmonella, a bacteria that can cause illness and at times can lead to death in young children, the frail or the elderly.

Such kind of food poisoning can result in diarrhea, fever, abdominal pain, cramps and other related symptoms that typically develop within 12 to 72 hours after the infection period. The salmonella infection lasts around four to seven days depending on the strength of the bacteria.

Trader Joe’s removed the walnuts temporarily from shelves when the samples tested positive for bacteria, but fortunately, till now, no illnesses have been reported.

Approval of Boston Scientific Corp’s device by FDA boosts company’s stock

Approval of Boston Scientific Corp’s device by FDA boosts company’s stock

On Monday, Boston Scientific Corp's stock climbed nearly 4%, thanks to approval of its heart device by FDA.

The agency approved the utilization of the left atrial appendage closure device known as Watchman in patients whose atrial fibrillation causes a high risk of stroke.

The device was approved as an alternative for patients who seek an alternative to blood-thinning warfarin drugs like Coumadin.

According to the American Heart Association, Atrial fibrillation is an irregular heart beat that feels like a quivering heart. This condition affects about 2.7 million people in the US as it increases the risk of stroke.

FDA warns about Likelihood of More Victims from Deadly Blue Bell Ice Cream

FDA warns about Likelihood of More Victims from Deadly Blue Bell Ice Cream

A warning about more victims has been issued by the US Food and Drug Administration over the Blue Bell ice cream brand Scoops being contaminated with the deadly Listeria virus that claimed three lives in Kansas over the weekend. The outbreak linked to Scoops lasted from January 2014 to January 2015, but the FDA has raised concerns over high chances of more victims in case of consumption of contaminated products kept in home freezers.

According to the FDA, five Kansans were infected by the deadly pathogen during their stay at Via Christi Hospital St. Francis in Wichita. They all were receiving treatments for unrelated conditions. The mortality rate of the pathogen is nearly 20%.

FDA issues tougher recommendations on reusable medical devices

FDA issues tougher recommendations on reusable medical devices

The FDA has issued stricter recommendations on reusable medical devices in order to prevent the spread of antibiotic resistant infections. These kind of infections occurred at Los Angeles hospitals.

According to the FDA, it has announced new recommendations for cleaning reusable medical devices like the duodenoscopes at the center of the ‘superbug’ infections. And the companies, which manufacture the scopes and other devices, will have to provide proof that the devices can be cleaned properly, prior to getting FDA approval.

According to the agency, manufacturers could conduct validation testing in order to prove that their cleaning and disinfection or sterilization instructions will help reduce microbial contamination properly.

FDA gives Green Signal to Double-Chin Treatment

FDA gives Green Signal to Double-Chin Treatment

A new revolutionary new treatment to remove double chins has sought an approval from the Food and Drug Administration (FDA). Both men and women in the United States face issues due to double chin.

Dermatologists tested the efficacy of the drug, known simply as ATX-101, to demand its approval from the FDA. Dr. Susan Weinkle, of Bradenton, in the Tampa Bay, Florida area, said after conducting the clinical trials that the treatment was found to be safe and amazingly effective. The approval of the drug means that double chin patients can get access to an alternative to other cosmetic treatments that are currently available, but are not safe and pose threat of bad side effects.

Boston Scientific receives approval from FDA for Watchman Device

Boston Scientific receives approval from FDA for Watchman Device

After a long and strange trip, developer and marketer of medical devices Boston Scientific has received green signal from the Food and Drug Administration (FDA) for its Watchman Left Atrial Appendage Closure Device in the United States. The manufacturing company was working on the device from a long time. Several times, it has been turned down by the federal agency of the United States Department of Health and Human Services.

FDA to ask Reusable Device Manufacturers to provide Safety Data

FDA to ask Reusable Device Manufacturers to provide Safety Data

In the wake of criticism the Food and Drug Administration (FDA) has recently faced for inappropriate response to infections spread by contaminated medical scopes, the health agency said on Thursday that it will make it mandatory for manufacturers of certain reusable devices to provide data to prove they can be cleaned reliably.

The agency also revealed in an announcement about its plans to entrust a panel of experts with the responsibility to study the safety issues with duodenoscopes. The panel is likely to be convened in May. It must be noted that these are the devices responsible for the recent outbreaks of a drug-resistant superbug at two Los Angeles hospitals. These devices also caused similar outbreaks around the country in recent years.

Kythera Biopharmaceutical’s Drug ATX-101 Very Close to FDA’s approval

Kythera Biopharmaceutical’s Drug ATX-101 Very Close to FDA’s approval

It has been reported that an injection developed by Kythera Biopharmaceutical Inc to get rid of double chin was backed by an independent panel of experts on Monday.

Stock of the biopharmaceutical company has tripled since it went public in 2012. Investors bet that the company's drugs can be the first ever drug approved in the United States to reduce localized fat deposits.

FDA's acceptance of recommendations given by the panel has brought the drug, ATX-101, closer to approval by the agency.

The drug, ATX-101, is a formulation of synthetically derived deoxycholic acid, which helps to destroy the fat that gets collected under the chin. The positive feature about the drug is that it destroys the fats without affecting the surrounding tissues.

FDA alters Label on Quit-Smoking Drug Chantix

FDA alters Label on Quit-Smoking Drug Chantix

The FDA has altered the label on the quit-smoking drug Chantix for creating awareness and address the concern over its potential to lower one’s tolerance level on alcohol and association with an annual risk of seizures.

The FDA warns, “Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately”.

The information provided by Chantix maker Pfizer and cases in the FDA Adverse Event Reporting System database served the basis of developing the new label.

US Dairy Farmers Giving Their Cows Illegal Antibiotics, Reports FDA

US Dairy Farmers Giving Their Cows Illegal Antibiotics, Reports FDA

A latest FDA report revealed that a few US dairy farmers are giving their cows some drugs. The presence of illegal antibiotics in milk, as shown by the report, has raised concerns that some farmers are not following food safety laws by giving cows drugs that routine tests cannot easily detect.

NPR reported that milk meant for commercial sale is tested for six commonly used antibiotics. It also told that any shipment that tests positive for any of those antibiotics is barred from entering the supermarket for ever.

Due to this strictness, farmers use antibiotics on dairy cows only when the cows are unhealthy and vet recommends it. When any cow is given antibiotics then milk production of that cow is put on hold.

FDA issues warning regarding Pfizer's Chantix

FDA issues warning regarding Pfizer's Chantix

It has been warned by the US Food and Drug Administration that Pfizer's anti-smoking drug, Chantix, leads to suicidal behavior and also causes other psychiatric side-effects. The agency issued the warning after it reviewed company findings, according to which the drug does not lead to such problems. The drug is reported to cause suicidal tendencies and aggressive or strange behavior among some patients.

On Monday, the FDA gave many updates about Chantix's labeling in which it also warned that the drug could also interact with alcohol. It has been reported by some patients that they experience bizarre or aggressive behavior, when they drink during the course of the drug.

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