fda •

Healthy Foods Illusion

July 8, 2016 By Jason Leathers Leave a Comment

Granola, frozen yogurt, and even quinoa skipped the list of healthy foods.

Granola has always been on the list of healthy foods, as it contains nuts, dried fruits, oats, and grains that make people love them. However, nutritionists show that not all the foods that look healthy have the necessary content of fibers, vitamins and mineral to sustain their appearance.

The Food and Drug Administration announced a future revision of the standards for healthy foods, in order to adjust the old figures with the newest discoveries in the field.

A recent survey compared the opinions of nutritionists with the general perception of the consumer. The result showed that people had very different expectations when it comes to healthy foods. The most poignant misconception involved granola.

The granola bars were considered by 71% of the public to be healthy. On the contrary, the percent of nutritionists that agreed was only 28.

When it comes to regular granola, the percentage of consumers rose to 80%, while the nutritionists remained at a cautious 47%.

One of the key points in these differences is that the regular granola and the bars can differ in terms of ingredients. Thus, the experts recommend always reading the nutritional label before buying them. The content in sugar and fat is as important as the number of calories and the ingredients.

Many of the granola products on the market are filled with sugar. For example, one bar contained oats as the main ingredient and sugar as its second. It included brown sugar syrup and honey.

Another product, labeled as peanut butter chocolate chip chewy granola bar, contained mostly brown sugar, sugar, and corn syrup.

The nutritionists warn that there is a big difference even among the type of sweeteners used in the granola products. For example, corn syrup is more quickly absorbed into the bloodstream than honey, and it can raise the level of blood sugar very fast.

Another product that raised a debate is coconut oil. 72% of the population considered it to be healthy, while only 37% of the nutritionists agreed.

The same thing happened with SlimFast Shakes, frozen yogurt, and quinoa.

The latter was a big surprise for everyone, as the seeds had been extendedly advertised as a miraculous food. It contains essential amino acids, proteins, fiber, vitamins, and minerals. The only problem is that it has to be consumed raw. Any cooking can drastically reduce its nutritional value. It seems that the general population disagreed with this.

On the bright side, the products that everyone agreed to be healthy are wine, sushi, hummus, shrimp, and tofu. They may not cover a week-long diet. However, it’s good to know healthy foods still exist.

Image Source: Pexels

The New Nutrition Label will Promote Healthy Food

May 23, 2016 By Jason Leathers Leave a Comment

The New Nutrition Label will Promote Healthy Food

Michelle Obama was the first person to introduce to the public the new changes FDA will make on the nutrition label of food products. These modifications will hopefully motivate consumers to make better choices while shopping for healthy food.

The American Administration for Food and Drugs has already added new conditions for the display of product packages and restricted the use of the words “healthy” and “natural” on food labels. A product will not be advertised as “healthy” if it doesn’t have a certain content of nutrients and low levels of saturated fat, sodium and cholesterol.

Adding up to this first initiative, FDA now updated the food label that informs the consumers on the nutritional content of the product. The new label will show updated percentages according to the current American specific health recommendations and will introduce new nutrients required to prevent and control chronic diseases.

The current design for the nutrition facts label is as old as 20 years. The new label should contain updated serving sizes and Daily Values percentages, and will display in a clearer way the nutrients and ingredients contained by the product.

The fields which include values for servings and calories will have larger and bolder fonts. A new field will be added in order to present the added sugars percent. Even the nutrient list had changed, and FDA will make sure the producer will declare the correct amounts on each product.

Consumers are encouraged to choose foods adequate to their lifestyle and health needs.

Daily Values for sodium and fibers have also changed. Sodium has been set to 2,300 milligrams, and fiber has a higher recommended value, 28 grams per day.

The sugars percentage has now being split to show what the ratio of added sugars is. Consumers will be able to see the exact nutritional facts for highly processed foods (which will contain a lot of added sugars) and to compare them with foods that have a more natural provenience.

Added sugars impair cognitive performance and lead to symptoms similar to withdrawal. They increase the risk for cancer and impact the cardiovascular system. Other effects are on dentition, skin and liver functioning, as much as creating the risk of diabetes and cutting down life expectancy.

The list of vitamins has been changed to show information on vitamin D and potassium percentages. Vitamin D helps to strengthen the bones and it lowers the risk for osteoporosis. Potassium has a proven efficiency in lowering blood pressure and removing a potential cancer threat.

Consumers will thus be encouraged to choose foods adequate to their lifestyle and health needs.

Image Source: Pexels

FDA Close to Approving Shot to Eliminate Double Chins

March 13, 2015 By Deborah Nielsen Leave a Comment

Although the final decision from the Food and Drug Administration (FDA) is not expected to come down until sometime in May, approval of a drug that helps reduce or eliminate double chins has received a green light.

The Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA is recommending approval of deoxycholic acid or DCA, which is an injectable drug proven to reduce submental fat associated with double chins in adults. If final approval is granted, DCA will be the first medical treatment for excessive fat underneath the chin.

Deoxycholic acid works by destroying fat cell membranes at the site of injection. Structurally, DCA is identical to endogenous deoxycholic acid although according to FDA regulations, there is a new molecular entity.

In the two clinical trials conducted, results showed that injectable DCA was far superior when compared to placebo, not only for primary endpoints but secondary as well.

In 13.4% and 18.6% of people who participated in the trials, two-grade improvements were noted. Comparatively, for participants in the placebo groups only 0.1% and 3% respectively were confirmed. In addition, 70% and 66.5% of participants had one-grade improvements whereas just 18.6% and 22% saw change within the placebo groups.

Using magnetic resonance imaging (MRI), medical researchers were able to see 46% and 40.5% improvement for those injected with DCA compared to 5.2% and 5.3% in the placebo groups. According to Dr. Lynn Drake, committee chair and lecturer at Harvard Medical School, as well as top dermatologist with Massachusetts General Hospital, DCA offers a solution that until this time has not been available.

She stated that improvement in little things like the reduction or elimination of chin fat can bolster a person’s self-worth and self-esteem.

The two pivotal, phase three trials were sponsored by Kythera Biopharmaceuticals and consisted of 1,022 patients from throughout North America. Most of the participants were white females between 40 and 50 years of age. During the trials, participants were injected using a 1 centimeter grid over a four-week period. The maximum number of sessions was six and no more than 50 injections of DCA were administered to each individual.

Dr. Leo McCafferty, a well-known plastic surgeon, was pleased with the outcome of the trials, saying that it is becoming more and more important to find medical procedures that are noninvasive, have little or no risk, and allow quick recovery.

New Blood Test to Predict Heart Attack got FDA’s Approval

December 17, 2014 By Rebecca McGhee Leave a Comment

US Food and Drug on Monday approved the new blood test that they believe can be helpful in detecting person’s risk of future heart condition and heart attack.

The test called PLAC Test for Lp-PLA2 is exclusive as it is designed for people with no history of heart disease and the studies have shown that the test is more accurate in predicting Coronary Heart Disease (CHD) risk in women specially Black women.

Alberto Gutierrez, the director of the Office of In Vitro Diagnostics and Radio-logical Health at the FDA’s Center for Devices and Radio-logical Health explained “A cardiac test that helps better predict future coronary heart disease risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious [heart disease] event, like a heart attack,”

The test measures the exercise of Lp-PLA2 (lipoprotein-associated phospholipase A2) – an enzyme that indicate vascular inflammation. Vascular inflammation is a harbinger of plaque accumulation in the arteries which can clog them resulting CDH.

The FDA elucidated “Patients with test results that show Lp-PLA2 activity greater than the level of 225 nano-moles per minute per milliliter are at increased risk for a [heart disease] event.”

The FDA’s approval is a result of a previous study made by U.S. National Institutes of Health in which NIH tracked 4,600 people of age between 45 and 92 for five years.

According to CDC, heart disease is amid the highest mortality rates in North America. ”Almost half of men and two-third of women die suffering from CHD with no previous symptoms.”

Nivolumab hailed as the Wonder Drug in the Fight against Cancer

December 7, 2014 By Rebecca McGhee 1 Comment

After the conduction of many successful clinical trials on patients suffering from Hodgkin’s Lymphoma, researchers have revealed that they believe Nivolumab is the obvious new weapon of choice in the fight against cancer.

Clinical trials done on patients with resistant forms of Hodgkin’s Lymphoma using this drug has made a huge breakthrough, suggest researchers. This wonder drug allows the immune system to destroy cancerous cells by efficiently recognizing them. Reports also suggest that it showed great promise amongst the 87% of the patients. After participating in this clinical trial, patients’ tumors showed a complete or partial remission.

Results attained during the course of these trials possibly reflect that Nivolumab may be one of the most potential treatments to increase the capability of the immune system in order to effectively identify and kill cancerous cells. Furthermore, trials conducted using the same aforementioned techniques in other types of cancers have also showed promising results in a separate study.

This wonder drug has been approved by the U.S Food and Drug Administration FDA and is already considered as a revolutionary drug in curtailing Hodgkin’s Lymphoma.

The study was led by Margaret Shipp and Philippe Armand and 23 patients who had resistant forms of Hodgkin’s Lymphoma participated. In essence the disease attacks white blood cells called lymphocytes and subsequently the bone marrow as well. It is the most common form of cancer in children and teenagers but overall less than 10,000 cases are registered in the U.S annually.

80 percent of the patients participating in the study had already undergone stem cell transplants but more than one third of them eventually relapsed. After six months 20 out of 23 patients tumors sizes shrank exponentially. Four of them were declared cancer free while the rest of them continue to show progress even after a year.

FDA’s Advisory Committee Approves Actavis (ACT) Anti-Biotic

December 6, 2014 By Germaine Hicks 2 Comments

Recently, Actavis plc (Nyse:act) declared that its trail anti-biotic, ceftazidime-avibactam, has been prescribed by the US Food & Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee, for treating intricate intra-abdominal diseases (cIAI) and convoluted urinary tract diseases (cUTI) brought on by drug resistant bacteria.

Actavis is co-creating the medication with Astrazeneca plc (ADR) (Nyse:azn). According to the terms of the agreement, Actavis possesses the privileges of the medication in North America, though Astrazeneca holds the rights for it in other nations.

The advisory group’s verdict was focused around the drug’s guaranteeing Phase II clinical trials, which have built its worth and safety for treating hospital patients with cIAI or cUTI, when limited or no alternating treatment is accessible.

Though, the anti-biotic was not able to get the board of trustees’ sanction for treating patients with hospital-acquired bacterial pneumonia (HABP), ventilator-acquired bacterial pneumonia (VABP), and bacteremia. The panel was not persuaded of ceftazidime-avibactam’s efficiency focused around the clinical trials information accommodated for these signs. The advisory group was also cynical about controlling the anti-biotics to patients with renal impairment.

The committee’s proposal is not obligatory on the FDA, which has a definitive power in settling on a final decision for the drug’s endorsement. Though, the FDA does consider the Committee’s proposal and typically gives comparative options; it is predictable to make its decision with respect to Actavis’ ceftazidime-avibactam New Drug Application (NDA) in the first quarter of next year.

In March a year ago, the medication got qualified infectious disease product (QIDP) status from the FDA, which makes it entitled for FDA’s fast track program and 5 years marketing uniqueness. The project facilitates the improvement and administrative methodology of medications created to treat life-threatening ailments, for which none or just a couple of affirmed medicines are accessible.

In August, Actavis declared positive results from the drug’s Phase III trials, Reclaim-1 and Reclaim-2. The trials looked at ceftazidime-avibactam’s adequacy and safety with the medication meropenem, in patients with cIAIs. The results demonstrated the medication met the aim of non-inferior treatment in comparison with meropenem.

The suggestion for the medication by the Advisory Committee is uplifting news for Actavis, as it can build its incomes by advertising its medications for the suggested signs, if FDA supports the medication. There are around 300,000 cases of cIAI reported every year.

Resistance To Antibiotics Tougher Than Thought

September 19, 2014 By Jason Leathers 1 Comment

The House Energy & Commerce Committee held a hearing regarding the growing alarm over antibiotic resistance and how to bring about new drug development. This, just one day after President Obama announced an executive order to create a new task force and action plan to battle the problem.

Committee Chair and Congressman Fred Upton said in his opening statement, “Make no mistake: we are losing effective antibiotic treatments because the pace of new and novel drug development has not kept up with these organisms’ ability to build resistance to the treatments available today.”

Antibiotic resistance comes about from continued exposure to the overuse of antibiotics. Bacteria and other pathogens then circumvent the antibiotics thus mutating and growing stronger. Much like if a man built a brick house against a cannon and the cannon knocked it down and the man built a house with more bricks and the cannon only could make a dent. Bacteria and other pathogens learn how to get around the treatments. Close to 2 million infections occur each year in the US and 23,000 deaths occur from resistant bacteria.

Director of the Center for drug Evaluation and Research at the FDA is Dr. Janet Woodcock who addressed the problem by bringing to light that the developing new antibacterial drugs is a major challenge. She said, “From a scientific standpoint, many patients with bacterial infections are often very sick and need to begin antibiotic therapy immediately. But enrolling a very sick patient in a clinical trial at the same time can be very difficult.”. In addition she pointed out that antibiotics are generally looked at as less profitable due to their low prices and short duration periods of application.

Dr. Woodcock continued, “The judicious use of antibacterial drugs is at odds with the traditional business models and marketing practices used by the pharmaceutical industry for other drug categories, and serves as just one more disincentive to investment in antibiotics.”. The Dr. also brought up the need for new business models for developing antibiotics that disassociate antibiotic drug sales with companies’ returns on investments or ROI.

Agreeing with Dr. Woodcock is Kenneth Hillan, CEO at biopharma company Achaogen Inc. He urged support for the DISARM Act (Developing an innovative Strategy for Animicrobial Resistant Microorganisms) which is supposedly going to reform reimbursement of antimicrobial products in hospitals by providing a value based pricing instead.

Hillan continued, “This would provide a powerful incentive. By providing separate reimbursement for qualifying antibiotics, the SISARM Act would provide manufacturers with the opportunity to price new antibiotics in a way that is commensurate with the value provided.”

Third Weight-Loss Pill Contrave (Naltrexone and Bupropion) Approved by FDA

September 11, 2014 By Chen Lai Leave a Comment

From the past two years, it’s for the third time, the Food and Drug Administration (FDA) has permitted a new weight-loss pill.

This Wednesday, the Contrave got approval from the Food and Drug Administration. Orexigen Therapeutics Inc., San Diego, has made the medication and will be marketed by Takeda Pharmaceutical of Japan. The chemical composition of the Contrave includes the some older drugs and two newer pills, Qsymia and Belviq, in order to help out adults fight their bulges.

There are lots of weight-loss medicines available in the market until now but none of them promise massive weight loss. They actually works by decreasing hunger and all have some side effects and drawbacks.

The FDA’s Jean-Marc Guettier reported in the press release that, obesity continues to be a key community health concern. He also claims that; When Contrave is being used as along with the combination of healthy lifestyle that includes a reduced-calorie diet and exercise, it provides another treatment option.

As compared to Contraves’ competitors, it is permitted for people who are obese or who are flabby and also going through some weight-related health problems, such as diabetes. Contrave is a combination of two drugs: naltrexone, which is also used to treat alcohol and drug dependence, and bupropion, an antidepressant also used as a smoking termination treatment.

FDA says, Contrave comes up with a caution that it may raise suicidal thoughts. Other potential side effects include increases in blood pressure and heart rate.

According to the experiments, patients taking Contrave loss 2% to 4.1% more weight than those taking placebo. Around 36% to 42% lost at least 5% of their body weight with the use of Contrave. Another FDA Belviq’s studies claims that average losses were 3% to 3.7% over placebo; for Qsymia, average losses were 6.7% to 8.9% over placebo.

In terms of potential sufferers, such weight losses can be significant, though it won’t happen if they just rely on pills, says Adam Tsai, a Denver internist who chairs the public affair committee of the Obesity Society, a group representing weight loss experts.

Tsai said that “The ideal candidate for a drug to treat obesity is someone who uses the drug as a tool, along with diet and exercise”.

Until now, the other new pills have not been big sellers. As per the reports of FDA, more than a third of U.S. adults, 78.6 million, are obese.

FDA Approves Merck Drug Keytruda for Melanoma Immunotherapy

September 5, 2014 By Chen Lai Leave a Comment

On Thursday, September 4, 2014, the American pharmaceutical company Merck (Merck and Co) stated that the Office of the quality control of products and medicines USA (Food and Drug Administration, FDA) approved the utilize of its medicine Keytruda for the cure of patients with severe or acute melanoma.

The medicine is proposed for the healing of unresectable or sever melanoma in patients who were cured before ipilimumab (ipilimumab). This medicine therapy has been approved for patients based on the results of a clinical study of 162 patients. A Merck drug for melanoma is clinically tested in laboratory by various microbiologist and they found this drug effective against melanoma.

Melanoma is the mainly the destructive type of skin cancer and the leading reason of death from skin disease. The main problem is that this disease cannot be surgically eliminated and it has been treated with medicines in the earlier time period. But due to the severeness of this disease all the drugs were low effective.

The most ordinary side effects reported by tolerant receiving double therapy, it – fever, chills, exhaustion, itchiness, vomiting, diarrhea, abdominal pain, swelling of the hands and feet, cough, annoyance, joint pain, night sweating, decreased hunger, constipation, and pain in the muscles. Severe side effects include: bleeding, blood clot, heart failure, skin problems and eye and kidney failure. Women of childbearing age should be alert that can cause birth defects and abnormal deliveries, and all patients should be informed that treatment of melanoma is very essential because it can lead to infertility, according tothe FDA.

The American pharmaceutical company granted priority condition given to the experimental medicine, this medicine is a humanized monoclonal antibody that enhances the immune system’s ability to resist common melanoma. The American regulatory agency recommended the drug for this suggested Keytruda to use an expedited procedure, based on the tumor responds to healing and duration of response.

On the other hand the representatives of Merck announced that the medical corporation is going to apply for approval of the drug in the European Medicines Agency (European Medicines Agency, EMA) by the end of 2014.

Categories