Tag Archive for 'FDA'

Three new weight loss drugs to be reviewed by FDA

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Jana
on July 12, 2010
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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

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Jana
on June 1, 2010
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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

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Jana
on April 23, 2010
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4150560901_2350ce120bIn 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

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Jana
on July 1, 2009
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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?

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Jana
on June 30, 2009
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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.”

Salmonella outbreak reveals FDA’s inadequacy

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Jana
on February 23, 2009
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The protection of our food supply by the U.S. Food and Drug Administration has recently shown to be extremely inadequate, with deadly consequences. Recently, more than 500 people in the U.S. have become sick and at least 8 have passed away from a salmonella outburst that was traced to peanut products.

A extensive analysis of the FDA was ordered on Monday, February 2, President Obama. He said that Americans should be able to trust the government to keep children safe as they eat peanut butter. His own daughter, Sasha, eats it for lunch. It is a shame that it takes a president with a young child at risk for the FDA to begin stringent standards for protecting our food supply.

Jean Halloran, director of Food Policy Initiatives for Consumers Union, says that consumers should be extremely angry. She says “The FDA is supposed to be a watchdog for consumers, and for too long, this agency has been coming up short.”

A Georgia processing plant is to blame for the recent outbreak. A criminal probe has begun because the FDA claims that the company knowingly shipped salmonella contaminated peanut butter out for almost a year. The company often retested the harmful products at a different lab just to get a negative reading.

What’s even more upsetting is that federal inspectors had not been to the Georgia plant since 2001. Also, when Canada held and refused a shipment that had metal fragments in it, the FDA  asked Georgia state inspectors to look at the plant, instead of its own inspectors. No samples were taken for inspection during the two visits. The FDA had to resort to bio-terrorism laws in order to acquire testing records from the company.

Unfortunately, these food safety issues are not unfamiliar to the public. Just last year, there was a jalapeno salmonella outbreak and in 2007, there was a lettuce problem. All this should put the spotlight on a problem that the Obama administration must conquer, which is an inadequate amount of FDA inspectors. There are less than 2000 in the agency. According to one expert, the scarcity of inspectors can often cause food producers to  go an astounding 15 to 20 years between inspections.

Jean Halloran claims that Congress should give power to the agency to order food recalls, to require annual inspections of food processing plants and demand that processors report tests that find infected products. A bill was introduced during the first week of February by a lawmaker that will reorganize federal food safety enforcement and require it to be more responsible. There are four main bills to revise the food safety system currently being constructed.

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