Tag Archive for 'FDA'

More study advised on connection between food dyes and hyperactivity

Published on April 30, 2011 in Health and Wellness. 0 Comments Tags: attention deficit disorder, FDA, food dyes, hyperactivity.

An advisory panel from the FDA has suggested that the agency study more about the tie between food coloring and childhood hyperactivity. This said, they claim that the products that have these dyes do not currently need warnings.

The committee voted 8 to 6 for food packages not to have warnings on packages with food colorings. Currently the products have to list the food colorings, but contain no warning about a potential link to hyperactivity. This committee consisted of doctors, scientists and consumer representatives.

The panel did agree with the FDA and indicated that there is not sufficient enough evidence to say that specific food dyes cause hyperactivity in most children. However, they were in accordance that diets that do not contain food dyes seem to work well for a considerable amount of children with behavior problems.

During a two-day meeting, the advisory committee looked at the links between the dyes and attention deficit disorder. The FDA agrees with studies that show hyperactivity and other behavioral problems are worsened by food dyes, as well as other substances found in foods. For most children, there is no proven effect.

The FDA and the panel now must decide if all this should lead to more regulation. Academics who have been studying the issue, as well as public advocates, both agree that the dyes do not seem to be the main cause of hyperactivity, but they claim that the effects of specific dyes on a percentage of children has caused enough concern to support a ban on the additives.

The meeting was held by the FDA in reaction to a 2008 petition that was filed by the advocacy group Center for Science in the Public Interest to ban Yellow 5, Red 40 and six other dyes. The director of the group, Michael Jacobson, said that he is disappointed that panel members were looking for exact scientific evidence that the link exists. He is pleased that at least the FDA is accepting the fact that food coloring may affect hyperactivity in some children.

Even though dyes are still found in U.S. foods, certain companies have decreased the use of dyes in food that are sold in Europe.

New DNA tests may eliminate most colonoscopies in the future

Published on February 15, 2011 in Health and Wellness. 0 Comments Tags: American Association for Cancer Research, colon cancer, DNA tests, FDA, Prevention.

Here is some good news for those of you who cringe at the thought of getting a colonoscopy: new research indicates that most colonoscopies will not be necessary in the future. Why is this? Well there have been two new DNA-based tests that claim to be able to detect colon cancer early. If this holds to be true, this will have a huge impact on reducing colon cancer. Colon cancer is a devastating disease that affects around 150,000 people a year in the U.S. and costs and astounding $14 billion to treat.

These new tests could allow the majority of people to bypass colonoscopies, which are currently recommended for people who are 50 and older. Instead of screening everyone, doctors may refer people for a colonoscopy only in cases where they have tested positive in one of the DNA tests.

It is believed that more people will go and get one of these DNA tests, because they are noninvasive in comparison to a colonoscopy, which uses a seeing tube that is fed threw the colon. These new tests could be available within the next two years.

In one of the test, created by Exact Sciences of Madison, Wisconsin, stool samples are examined to see if they contain the four altered genes that are characteristic of colon cancer. This test could find cancerous and precancerous tumors at an early curable stage that can be removed quickly.

The other test searches for changes in a single gene, called Septin 9, which is not one of the Exact Sciences’ panel of four genes. Epigenomics AG in Germany developed this test.

The good news is that both of these tests would be less costly than a colonoscopy and perhaps even more effective. The first test, which examines stools, will cost around $300. The current average cost of a colonoscopy is around $2000. A lot of people tend to avoid colonoscopies because they are invasive, and the general cost per detection is high since most people are in pretty good health. They also miss many tumors in the upper part of the intestine.

Exact Sciences has decided to sign up several thousand patients in a future trial that they hope the FDA will approve. The trial will be finished in 2012 and the test will be available soon after that, as long as it is approved.

Dr. David Ahlquist from the Mayo Clinic, who is an adviser to Exact Sciences, said “If widely used, and regularly, this test really does have the opportunity to eliminate colon cancer.”

Of course, the value of the tests depend heavily on details such as their sensitivity, which means the proportion of detected tumors and their specificity, or how many of the positive results are false alarms. In July, Exact Sciences claimed that its test was extremely sensitive and specific when applied directly to cells taken from tumors. In reality, the tumor DNA has to be detected in stool samples. This is a much harder to accomplish, because almost all the DNA comes from the bacteria of the gut, and only 0.01 percent of the DNA in feces is human. In October, the company revealed at a meeting of the American Association for Cancer Research that in a trial of 1,100 patients, the test detected 64 percent of polyps, larger than 1 centimeter in diameter, and 85 percent of cancers, as judged by the colonoscopies that were also performed on the patients.

Dr. Ahlquist is happy with the results, particularly the 64 percent detection rate for precancerous polyps.

Even though this detection rate seems less than perfect, it will be highly effective is the test is performed on a regular basis. Ahlquist said that “The pap smear detects only 50 percent of cervical cancers, but applied over time it virtually eliminates the disease.”

The Exact Sciences test specificity is 88 percent. This means that 12 percent of the time a patient will be given a false alarm. This may not be so bad, since the worst that will occur is that the patient will have to undergo an unnecessary colonoscopy.

Two new drugs may help fight hepatitis C

Published on January 24, 2011 in Health and Wellness. 0 Comments Tags: boceprevir, FDA, Hepatitis C, Prevention, telaprevir.

Things may be looking up for a long overlooked epidemic. There will be two very powerful drugs available soon that may help cure many people of the hepatitis C disease which attacks the liver. This said, most people who have the infection are not even aware of it yet.

Remarkably, around two-thirds of hepatitis C sufferers are believed to be baby boomers who may have acquired this disease in their carefree youth. The virus can take twenty to thirty years to complete its damage.

Perhaps it is time to consider if the government should suggest that baby boomers be checked for hepatitis C like they are for cancer.

This two-drug treatment for hepatitis C will cure about 40 percent of people who have the common variety of the virus, but can cause some unwelcome side effects. Major studies reveal that adding a new drug – either Vertex Pharmaceuticals’ telaprevir or Merck & Co.’s boceprevir – can lift those cure rates to as high as 75 percent. They also allow people to cut treatment time in half, about six months, which will reduce how long they have to endure those terrible side effects.

If the FDA approves the drugs, they would be the first to directly target the hepatitis C virus. The decision is expected to be announced sometime this summer.

The most significance could come if more people would get tested for hepatitis C, which is a blood-borne virus. Most people think that it is a only a risk for those who inject illegal drugs. The virus could also have begun from blood transfusions before 1992. Testing of the blood supply was not performed until then.

People are still exposed today in health care facilities due to errors in infection control. Even a one-time experiment with drugs, perhaps in college, could also expose someone. Many doctors are hesitant to ask a middle-aged conservative patient to reveal, according to Dr. John Ward.

Embryonic stem-cell therapy has begun

Published on November 1, 2010 in Health and Wellness. 0 Comments Tags: embryonic stem-cell therapy, FDA, Geron Corp., Spinal cord injuries.

In the very first authorized test of this type of technology in the U.S., stem cells obtained from human embryos, are being utilized to treat a patient who has acute spinal cord injuries. The patient was treated in early October at Shepherd Center, a rehabilitation hospital for spinal-cord injury patients in Atlanta, Geron Corp.

The study is devised to test the safety and tolerability of Geron’s stem-cell therapy in patients who have spinal cord injuries resulting in loss of mobility or sensation. In July, the FDA granted the bio-pharmaceuticals company the green light to begin the study after hesitating for about a year over safety issues.

For over ten years, scientists have pushed for studies on stem cells to acquire treatments for Parkinson’s disease, multiple sclerosis, spinal cord injuries and diabetes. Since stem cells can grow into any type of tissue, they have the possibility to mend cells and speed up treatments.

When Geron first started to work with human embryonic stem cells back in 1999, many people thought that it would be many decades before cell therapy would be approved for human clinical trials. Thomas Okarma, the company’s president and chief executive officer, said the news symbolizes “a milestone for the field.”

Geron has unfolded a process that makes embryonic stem cells into glial cells, a type of nerve cell that assists in sustaining the work of neurons. After a spinal cord injury, nerve cells are unable to send information down the spine, which results in paralysis.

Geon’s clinical trial will first focus on patients who have severely damaged, not severed, their spinal cords in the region that begins below the neck, according to the company. The procedure will let the company inject a small amount of stem cells, then increase the dosage in subsequent patients.

Caffeine and alcohol drink: A dangerous combination

Published on November 1, 2010 in Health and Wellness. 0 Comments Tags: alcohol, caffeine, FDA, Four Loko, FTC, Prevention.

We’ve all heard of people who have taken caffeine while drinking alcohol. Recently though, a breakout of cases where students, as well as others, have ended up the hospital after they had drinks that contained both caffeine and alcohol in the same can. College and health officials are very alarmed and concerned by these occurrences.

Doctors report that the drinks are dangerous, because the caffeine conceals the effects of the alcohol, preventing those who drink them to feel just how intoxicated they really are.

There is a brand in particular, called Four Loko, a fruit-flavored malt beverage with an alcohol content of 12 percent containing as much caffeine as a cup of coffee, that has come under specific criticism. Students at Ramapo College in Mahwah, N.J. and Central Washington University in Ellensburg, Washington, drank it and wound up in emergency rooms, some with very elevated levels of alcohol poisoning.

Dr. Michael Reihart, an emergency room doctor in Lancaster, Pa., said it “is one of the most dangerous new alcohol concoctions I have ever seen.” He has treated more than twelve teenagers and adults in the last three months who came to him after drinking Four Loko. He said it is a deadly recipe because your body naturally wants to sleep, but it is tricked by the caffeine.

After 18 attorney generals urged that the drinks be examined, the Food and Drug Administration is looking into whether or not the drinks are safe. The FDA has never approved of adding caffeine to alcohol. In July, Sen. Charles Schumer, D-N.Y., asked the FTC to investigate if the drinks are especially designed to appeal to underage drinkers. It is a fact that the drinks have colorful packaging and flavors such as watermelon, blue raspberry and lemon-line.

Even though no legislation has passed yet, several states have tried to ban the drinks.

The president of Ramapo College, Dr. Peter Mercer, banned Four Loko and other energy drinks that contain caffeine and alcohol after 6 students ended up in the hospital after drinking Four Loko. One of the students said he had 3 three cans of Four Loko and a couple of shots of tequila in only one hour. He had a blood alcohol level of .400 after this.

The co-founder and managing partner of Phusion Projects, which is the 5-year-old Chicago company that owns Four Loko, said that the drink, introduced in August of 2008, was being unfairly scrutinized. According to him, the company takes measures to try to keep minors from being able to obtain the drink. Also, Phusion Projects wonders why a police investigation into the Central Washington University incident had centered on Four Loko, when the police report claimed that several other alcoholic drinks, including beer, were also discovered at the party where the students became sick.

Three new weight loss drugs to be reviewed by FDA

Published on July 12, 2010 in Health and Wellness. 0 Comments Tags: amphetamine, anticonvulsant, FDA, lorcaserin, Obesity, Qnexa, weight loss drugs.

We are all holding our breath that maybe one or all three of these new weight loss drugs will help many be successful in losing weight without those unwelcome, and sometimes dangerous side effects. Doctors, investors and dieters will be allowed to take in their first observation of the new drugs this week.

These are the first new prescription drugs to come out in more than ten years. Since U.S. obesity rates are close to 35 percent of the adult population, the anticipation is very high. Even a drug that is somewhat effective is very exciting.

However, not one of the three drugs seems to be on the brink of a major success in research. Not much success has come from the makers of drugs when it comes to comprehending and treating the triggers of overeating. With two of the drugs presented for approval, drugs that are already out there were joined together – an anticonvulsant and an amphetamine – but not without troubling side effects. The third drug is a safer medication but seems to be less effective.

Safety issues have always been a problem for decades in the never-ending search for a successful breakthrough weight loss drug. Perhaps the most memorable one was the Wyeth’s diet pill drug combination fen-phen. It was taken off the market in 1997 due to its connection with heart valve damage and lung problems.

The review of Vivus Inc.’s pill Qnexa will be posted by the FDA July 12 and they will hold a public meeting July 14 to review the data. Orexigen Therapeutics Inc.’s Contrave is to be reviewed in October and Aren Pharmaceuticals Inc.’s lorcaserin is to be reviewed in December.

In clinical trials, Qnexa was the winner with the best weight loss results in clinical trials. In this trial, patients lost between 13 and 15 percent of their body weight. On the down side, this drug had the most amount of patients quitting due to undesirable side effects, which included memory and concentration problems.

Potential liver damage with two weight-loss pills

Published on June 1, 2010 in Health and Wellness. 0 Comments Tags: Alli, FDA, GlaxoSmithKline, liver damage, Prevention, Roche, Xenical.

Federal health officials from the FDA are warning consumers that two weight loss pills, called Alli and Xenical, could cause sever liver damage in rare cases.

The Food and Drug Administration said recently that it has put a warning concerning the risk on the label of the drug Alli. Alli is sold over-the-counter by GlaxoSmithKline. The prescription version Xenical is manufactured and marketed by Roche.

The FDA has identified 13 cases of liver damage associated with these two drugs.

Glaxo’s rotavirus vaccine is temporarily suspended by FDA

Published on April 23, 2010 in Health and Wellness. 0 Comments Tags: FDA, Glaxo, Merck, Prevention, Rotavirus vaccine.

4150560901_2350ce120b In March, pediatricians were told by U.S. health officials to temporarily stop using one of the two vaccines used to prevent a leading cause of diarrhea in infants. This was done after they found doses of Glaxo-Smith-Kline’s Rotavirus contaminated with a benign pig virus.

Millions of children around the world have been vaccinated with Glaxo’s vaccine with no safety issues and the pig virus is not known to cause any type of illness in people or animals according to Dr. Margaret Hamburg, who is the commissioner of the Food and Drug Administration.

The Rotavirus causes extreme diarrhea and is the leading killer of children in developing countries. About 55,000 children in the U.S. were hospitalized for rotavirus infections before vaccination began with the Merck’s vaccine in 2006 and Glaxo’s in 2008.

Glaxo said that regulators abroad have decided not to alter how Rotarix is used as scientists research the importance of this new finding.

The oral vaccine, Rotarix, is created from a diluted strain of human rotavirus that is grown inside living cells before it is purified into a vaccine dose. Glaxo uses a line of monkey kidney cells or vero cells. According to Hamburg, the pig virus DNA fragments have been found in Glaxo’s cell bank. This means that they were there from the earliest development of the vaccine. It is not yet known how the contamination happened but an investigation is being performed.

The rotavirus vaccine created by Merck is made by a completely different process.

FDA panel recommends decreased acetaminophen doses

Published on July 1, 2009 in Health and Wellness. 0 Comments Tags: acetaminophen, FDA, Prevention.

On June 30, a federal advisory panel voted to propose a ban on Percocet and Vicodin, which are two of the most desired painkillers. The reason for this ban is because of the harmful effects that they can have on the liver.

A combination of a narcotic and acetaminophen is found in these two drugs. Acetaminophen is the ingredient that is found in common over-the-counter products such as Tylenol and Excedrin. Large amounts of acetaminophen are a leading cause of liver damage. The panel mentioned that patients who take Percocet and Vicodin for extended periods of time ususally need more and more increased doses. The panel’s vote, which arose out of a meeting to advise the FDA on problems stemming from the increasing popularity of acetaminophen, was 20-17 to recommend a ban on the combination drugs.

In 2005, 28 billion doses that contain acetaminophen were bought by American consumers. Every year, there are more than 400 people that die and 42,000 who are hospitalized from overdoses in the U.S.

There are at least 7 other prescription drugs in which acetaminophen is combined with different narcotics, and if the FDA listens to the expert’s advice, all of these combination pills will be banned. Vicodin and its generic equals are prescribed more than 100 million times annually in the United States.

The committee also voted 24-13 to suggest that the FDA decrease the highest allowed dose in o.t.c. medicine such as Tylenol from 500 milligrams to 325. They also voted 21-16 to bring down the maximum daily dosage to less than 4,000 milligrams.

Tylenol’s maker, Johnson & Johnson, said that it disagrees with the recommended restrictions on acetaminophen, saying that it might lead to even more dangerous results as people move towards other over-the-counter products such as Advil and aspirin.

Children’s medicines that contain acetaminophen were also an issue as the committee voted 36-1 to limit them to a single formulation. Currently the liquids are sold in two different concentrations, which confuses some doctors and parents. After deliberation, FDA officials indicated that they would probably decide on the less concentrated formula. That way, if parents make a mistake, there would be less chance of an overdose.

A lot of over-the-counter cold and cough medicines such as Excedrin and Nyquil contain acetaminophen. Accidental poisonings happen when two or more of these combination products are taken because the danger is not known. A vote of 24-13 was cast against the ban against these children’s medicines because the danger was perceived as slight.

A study done in 2005 showed that the majority of poisonings happened when people took Vicodin or similar products containing a narcotic with acetaminophen.

Why so many new food recalls?

Published on June 30, 2009 in Health and Wellness. 0 Comments Tags: Centers for Disease Control and Prevention, FDA, food-borne illnesses, Prevention.

Early this year we were cautioned against eating pistachios and peanut butter, and then in April, the FDA strongly suggested that we not eat raw alfalfa sprouts. Now we are warned about a specific brand of cookie dough.

If you think there seems to be more recalls, you’re right! There were 214 food recalls in 2006, 247 in 2007 and 310 in 2008 according to the Food and Drug Administration (FDA).

Surprisingly, food manufacturers say this is not bad, it’s actually a good thing. Dr. Robert Brackett, chief science and regulatory-affairs officer for the Grocery Manufacturers Association, says “It may look like the food supply is getting less safe, but it actually means that we’re getting better at detecting the outbreaks.” The Centers for Disease Control and Prevention (CDC) has figures that appear to uphold Brackett’s findings, which reveal the decrease of food-borne illnesses as the food recalls have increased in the past few years.

The FDA’s associate commissioner for food safety, Dr. David Acheson, reports that the agency is getting more diligent when it comes to finding health dangers before any illness is reported. Acheson gave an example of this by mentioning the pistachio recall, explaining that the nuts were taken off the shelves before anyone got ill.

Having said all this, there are some lawmakers that are still concerned that the FDA isn’t doing all they can, so they are working on a new bill that will tighten regulations. This legislation would force food manufacturers to closely follow the distribution of their products, as the FDA would make more numerous visits to food manufacturing plants.

There are now more challenges than in the past because of the worldwide distribution of the food supply. There are more chances for contamination because of more stops from the farm to the home.

Recently, the FDA has opened offices in China and India to keep in closer contact with food producers there. Fortunately new advances in surveillance technology has allowed the CDC to be able to track the genetic fingerprint of food-borne illnesses all over the nation, which lets the FDA caution Americans more quickly when it comes to possible health risks.

This said, even though there is increased oversight, the FDA advises that there will still be some recalls. Acheson says that “It’s not possible to be inspecting and testing every food item; you simply cannot do it.”