FDA

FDA calls companies for trial of testosterone supplements

FDA calls companies for trial of testosterone supplements

According to reports, US Food and Drug Administration (FDA) has called companies that create testosterone products for carrying out a large clinical trial in an attempt to find out the accurate benefits and risks of using the hormone.

Christine Nguyen, MD, of the FDA, and colleagues said in a New England Journal of Medicine perspective that their agency is calling testosterone drug makers for making efforts together on one large controlled trial.

Recently, researchers noted the difference between hormone therapy for males and females. They observed that the Women's Health Initiative gave answers of important questions regarding hormone replacement, together with its risks of breast cancer and heart attack. Experts said that there has not been a comparable trial for males.

Asexual Community condemns Approval of Flibanserin

Asexual Community condemns Approval of Flibanserin

The approval of Addyi (flibanserin), a non-hormonal drug to treat low interest in sex among women, by the US Food and Drug Administration has sparked a debate, bringing cultural and medical factors in for defining what normal human sexual desire is.

There is no doubt that the drug will better the plight of many women who are diagnosed with hypoactive sexual desire disorder (HSDD), which results into lack of interest in sex. The drug will be available for sale this fall and many physicians will not show any reluctance to prescribe the drug to women who need them.

FDA approves First Drug to treat Low Sexual Desire in Women

FDA approves First Drug to treat Low Sexual Desire in Women

There are many drugs available for men that increase their sexual libido, but there was none for women. But now, that thing is of past, as on Tuesday, US health regulators have approved the first such drug for women to treat low sexual desire. The approval has come with a warning that it could cause low blood pressure, fainting is also possible and chances increase when taken with alcohol.

The pink-colored pill developed by Sprout Pharmaceuticals will be sold under the brand name Addyi. Owing to safety issues, the drug will only be available through certified and specially trained health care professionals and pharmacies.

FDA could soon approve first female libido pill

FDA could soon approve first female libido pill

According to reports, a drug named “female Viagra” could be approved by a US supervisory body this week. It may open the door for its distribution all around the world. As per industry experts, within few days, flibanserin could be approved.

If it is approved, it will become the first authorized drug for low sex drive in females that will be available in the market. The drug fights a waning libido by targeting the pleasure centre of brain of a woman in place of the genitals. In trials, women who took the drug daily were having sex regularly and were also enjoying it more.

FDA Approves OxyContin for Kids as young as 11 years old

FDA Approves OxyContin for Kids as young as 11 years old

The Food and Drug Administration (FDA) announced on Thursday that it has approved frequently abused painkiller OxyContin for kids as young as 11 years old. According to the federal agency of the United States Department of Health and Human Services, only limited use of the drug has been approved.

Dr. Sharon Hertz, director of new addiction products for the FDA, said, “Studies by Purdue Pharma of Stamford, Connecticut, which manufactures the drug, "supported a new pediatric indication for OxyContin in patients 11 to 16 years old and provided prescribers with helpful information about the use of OxyContin in pediatric patients”.

FDA warns Kim Kardashian West over Promoting a Pregnancy Drug

FDA warns Kim Kardashian West over Promoting a Pregnancy Drug

Television Personality and model Kim Kardashian West has been warned by the Food and Drug Administration (FDA) over promoting a pregnancy drug. The federal agency of the US Department of Health and Human Services also asked Duchesnay, pharmaceutical company based in Canada, to remove all those social media posts where Kardashian has been promoting the drug.

While providing information about the warning given to Kardashian, FDA stated that the 34-year-old Kardashian’s remarks could convince people to take the drug Diclegis. Robert Dean, a member of Drug Promotion office of FDA, stated in a letter that Kardashian has violated the law and the violations can beserious concerning from a public health perspective.

US FDA warns Public over Contaminated Tattoo Inks in Florida

US FDA warns Public over Contaminated Tattoo Inks in Florida

The US Food and Drug Administration (FDA) has warned people who might be thinking of getting a tattoo in Florida that a number of Florida tattoo shops are using tattoo inks that have the microbial contamination.

It has been learnt from the investigation that Mycobacterium chelonae was present in a group of inks from A Thousand Virgins with a lot number of 129. The investigators also found certain strains of molds. The ink in question is three shades of gray: G1, G2 and G3. The bottles containing those inks have January 2016 mentioned as expiry date.

The FDA responded to requests of health authorities from the state provide additional support. Complaints have been received by them for bacterial infection among recently tattooed consumers.

Federal Judge allows Amarin to Promote Benefits not covered in FDA-approved Labeling of Vascepa

Federal Judge allows Amarin to Promote Benefits not covered in FDA-approved

A twist in the tale came when a Federal judge in New York approved Amarin Pharma’s request for a ban against the enforcement by the US Food and Drug Administration of rules, which otherwise does not allow communicating physicians about the information on unapproved uses of its Vascepa.

As per the order, the company can share the information about the drug’s effect witnessed in the late-stage ANCHOR trial. In the trial, the product was tested on patients having quit high levels of triglycerides after statin therapy.

FDA Lays Out Additional Safety Measures to Clean Specialized Medical Scopes

FDA Lays Out Additional Safety Measures to Clean Specialized Medical Scopes

There have been instances where specialized medical scopes have been linked with deadly bacterial outbreaks. Lately, federal health officials have come up with extra safety measures that hospital can adopt to clean these scopes.

Along with this, the FDA officials stated that not every hospital had the needed resources to take the steps, which included sterilizing scopes with toxic gas. They have also affirmed that there are chances that even after adopting these steps, the risk of infection transmission cannot be completely ended.

FDA approves anti-epilepsy pill manufactured with 3D printer

FDA approves anti-epilepsy pill manufactured with 3D printer

The US Food and Drug Administration has given go-ahead for the sale of an anti-epilepsy pill manufactured with a three-dimensional (3D) printer. The FDA has approved Spritam medication for the treatment of epilepsy, said Aprecia Pharmaceuticals in an announcement.

ZipDose 3D printing technology of the company allows creation of a detailed, porous structure, which expedites the process of dissolving a pill while delivering up to 1,000 mg of medication in a single dose.

First 3-D printed prescription drug for epilepsy gets FDA approval

First 3-D printed prescription drug for epilepsy gets FDA approval

The Food and Drug Administration (FDA) has given a nod to the first prescription drug that has been developed through 3-D printing. The tablet, meant for treatment of seizures in adults and children, will be a soluble.

The drug, named Spritam, has been developed by Aprecia Pharmaceuticals. The manufacturing involves a layered process using 3-D printing. A patient will have to take it with liquid.

According to officials at Aprecia Pharmaceuticals, an Ohio-based company, the drug doses of up to 1,000 milligrams can constitute single tablets. The drug will be available in markets in early 2016.

A spokesperson from the FDA confirmed the development. Once Spritam is launched, Aprecia will develop other medicines also using the same technology in the years ahead.

Balloon System for Obesity Treatment gets Green Signal from FDA

Balloon System for Obesity Treatment gets Green Signal from FDA

On Tuesday, the Food and Drug Administration has given green signal to an inflatable medical balloon manufactured by Reshape Medical for the treatment of obesity in adults. The balloon helps patients lose weight by filling up space in stomach.

Using an endoscopy, the balloon is inserted into patient's stomach and then filled with saline solution. FDA said that the procedure that takes not even half an hour requires person to be sedated. Earlier also, there was a balloon device, but it was withdrawn in 1992 because it had ruptured and blocked patients' arteries.

Here’s why cilantro from Puebla, Mexico, is banned in US

Here’s why cilantro from Puebla, Mexico, is banned in US

As a result of shortage of sanitation facilities in Mexican produce fields, a product has been banned in the US. However, Mexico is not the only place where there are problems related to field sanitation, according to US farmworker groups.

It was reported that some Mexican farm workers are relieving themselves in cilantro fields that are intended for making American tables. It may lead to concerns for consumers. It may also lead to other health problems for the farmworkers.

Presidential candidate Donald Trump said that "infectious disease is pouring across the border" and could affect the quality of Mexican cilantro and it is completely a foreign policy issue. According to farm worker advocacy groups, this problem is also there in American fields.

Drug manufacturers usually don’t report adverse effects of medications on time

Drug manufacturers usually don’t report adverse effects of medications on time

According to a study, companies didn't report approximately one in 10 severe and unexpected medication side effects to the US Food and Drug Administration (FDA). The reports were to be given within a 15-day time that was specified by federal regulations in order to protect patient safety.

Researchers at the University of Minnesota carried out the study. According to an analysis of 1.6 million side effects reported to the FDA from 2004 to 2014, drug manufacturers generally do not disclose serious adverse events within this period when patient deaths occur.

Kroger Company recalls spices due to possible Salmonella Contamination

Kroger Company recalls spices due to possible Salmonella Contamination

Owing to possible salmonella contamination, the Kroger Company is recalling different species including Kroger Ground Cinnamon, Kroger Garlic Powder, Kroger Coarse Ground Black Pepper and Kroger Bac'n Buds, which have been sold in retail stores.

The FDA tested a sample of Kroger Garlic Powder from a store in North Augusta, South Carolina and it was found to be contaminated with salmonella. For now, no illness case has been reported with regard to the spices.

FDA’s Proposal to Mention Amount of Added Sugar in Products Opposed by Food and Beverage Industries

FDA’s Proposal to Mention Amount of Added Sugar in Products Opposed by Food

The US Food and Drug Administration (FDA)’s proposal that all food labels will have to list the amount of added sugar and recommended consumption levels has faced strong opposition from the food and beverage industries.

The proposal is part of an overhaul of the nutrition facts label proposed last year by the Obama administration. Usually the labels on food and beverages contain percent daily values for other nutrients, but they do not contain any information about the added sugar.

Therefore, a government advisory committee recommended people that they must get not more than 10% of calories daily from added sugars.

Odomzo gets FDA’s Approval

Odomzo gets FDA’s Approval

The US Food and Drug Administration has given green signal to a new drug meant for patients diagnosed with advanced basal cell carcinoma, a common cancer in skin’s top layer. The drug, Odomzo, is meant for patients whose cancer has not spread to other body parts and is not treatable with other treatments.

It is a once-daily pill and has been designed to inhibit the Hedgehog pathway. The drug’s efficacy was tested in a clinical study having 66 people. The FDA stated that 58% of people treated with 200 mg of Odomzo witnessed their tumors shrink or disappear.

FDA proposes Changes in Nutrition Facts panel

FDA proposes Changes in Nutrition Facts panel

On Friday, the US Food and Drug Administration proposed a rule that labels should include a percent Daily Value for added sugars on the Nutrition Facts panel. The proposal is an addition to a rule proposed by the agency in March as per which, food companies should include added sugars to Nutrition Facts labels.

The FDA has stated that added sugars are added by manufacturers while preparing them and it should not exceed 10% of calories consumed. These changes are considered to be the first ones being taken in 20 years.

Robotic surgery led to 144 deaths in 14 Years: Study

Robotic surgery led to 144 deaths in 14 Years: Study

According to a study conducted by the United States Food and Drug Administration (US FDA), the use of robots to perform surgery has led to multiple deaths and injuries within a period of 14 years. The issues that led to these deaths include broken pieces falling into bodies of patients, the burning of patients, in addition to “uncontrolled movement”.

According to a team of researchers from University of Illinois at Urbana-Champaign, Massachusetts Institute of Technology and Rush University Medical Center, robotic surgery is quite popular, but many complications are linked to it.

Elizabeth Holmes’s new project to provide cheaper, faster blood test to patients

Elizabeth Holmes’s new project to provide cheaper, faster blood test to patients

Elizabeth Holmes, youngest female billionaire in the world, is the owner of Palo Alto-based Theranos. She wants cheaper and faster and less painful alternatives to replace traditional blood tests.

The project has gained popularity despite big players in medical industry like Laboratory Corp of America and Quest Diagnostics.

“This is a milestone in bringing our technology and services not only to our Wellness Centers, but also to physician offices and hospitals. Now the lab can come to people at the time it matters, rather than the other way around”, said she.

Access to these new tests will be soon provided through drug stores. Unlike blood tests that require a syringe and an entire vial of blood, the new tests rely on just a single drop from a finger prick.

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