The approval of a new antiplatelet drug which will eventually become a competitor with clopidogrel (Plavix) has been delayed by the Food and Drug Administration (FDA). The new drug, ticagrelor, was recently approved in Europe. The drug has received quite a bit of coverage in the lay press here in the U.S.

The FDA has asked for further evaluation of the PLATO trial which is a study conducted on 18,000 patients in 43 countries around the world to evaluate the new drug. In the 1,814 patients studied in the U.S. and Canada the outcome was worse in the patients taking ticagrelor as compared to clopidogrel (Plavix).

A spokesperson for drug company AstraZeneca says that the company remains confident that the drug will be approved. bjmdjd

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antiplatelet drug · AstraZeneca · clopidogrel · PLATO trial · Plavix · ticagrelor

It appears that one of my favorite opioid pain medications will no longer be available in the United States. The Food and Drug Administration (FDA) has asked that propoxyphene (brand names Darvon and Darvocet) be withdrawn from the U.S. Market. All generic formulations will also be withdrawn.

Some new data that has come to light shows that patients using propoxyphene are at an increased risk of cardiac rhythm abnormalities that can be serious and even fatal. This is true even at the recommended doses. Withdrawal of the drug is already underway in Europe.

Long term users of the drug are not being asked to abruptly stop their medication but to call or visit their healthcare provider to discuss a change in their treatment plan. bjmdjd

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cardiac side effects · Darvocet · Darvon · FDA · Food and Drug Administration · propoxyphene

I am sooooooo happy to report that the Food and Drug Administration has announced that there is no evidence that any non prescription chelation products actually rid the body of toxic metals nor are they useful in the treatment of any diseases.

Prescription chelation products for problems like iron overload or lead poisoning have long been recognized as appropriate treatments for these conditions. The non prescription products are not known to treat any conditions or diseases though they are claimed to be miracle cures for everything by some.

Chelation has long been tauted by many alternative practitioners to treat many conditions however the one treated most effectively is the practitioner’s empty back pocket. They seem to work well for that problem since patients must pay cash as the treatments aren’t recognized by most third party payers.

The FDA warned eight different companies to stop selling their products and that making unsubstantiated claims about the products is a violation of federal law. I guess it’s OK for practitioners to make unsubstantiated claims about the usefulness of chelation. bjmdjd

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The Food and Drug Administration announced today that Abbott Laboratories has withdrawn the weight loss drug sibutramine (Meridia) from the market. The FDA asked the company to withdraw the drug after post marketing studies revealed that the risks of cardiovascular complications outweighed the modest weight loss achieved with using the drug.

Compared to placebo there was a 16% increase in non fatal heart attack, non fatal stroke, the need for resuscitation after cardiac arrest, and death. It was felt that the problems were caused by the drug increasing blood pressure and heart rate. They also announced that the risk of problems resolved when the medication is stopped.

Doctors have been asked to stop prescribing the drug and patients have been asked to stop taking it. The FDA also advised against taking the weight loss product Slimming Beauty Bitter Orange Slimming Capsules which is sold over the Internet and contains sibutramine (Meridia) though it is not listed on the ingredients label. bjmdjd

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Abbott Laboratories · cardiovascular complications · Food and Drug Administration · Meridia · sibutramine

What is the world coming to? No need to worry about dieting anymore. With laser treatments the cellulite will just melt away. For a price I’m sure.

Thursday the Food and Drug Administration cleared the way for a painless laser treatment to get rid of that cellulite. Four pads are placed on the skin overlying the affected area and left in place for ten to twenty minutes. Supposedly the fat cells open up and release fat which is then transported to areas of the body where it can be dissolved and released during exercise. It is suggested that the patient exercise for twenty to thirty minutes immediately after the treatment if possible but it can be delayed for up to twelve hours if needed. Eight to ten treatments over a four week period is suggested.

The FDA also recently approved a cold laser for cellulite reduction treatments. Get out your wallets girls (and boys). bjmdjd 

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cellulite · cold laser · FDA · Food and Drug Administration

As most everyone who is taking the diabetes drug Avandia knows the medication has been under scrutiny in the U.S. and in Europe for some time. The FDA has decided to allow continued marketing of Avandia in the U.S. with restricted access while the European Medicines Agency has announced that all drugs containing Avandia will be off of the market in the next few months. They announced that the information that they now have no longer supports the view that the benefit of using the drug outweighs the cardiac risks involved.

The restricted access plus the fact that there is another drug available like Avandia without the same cardiac risks may signal the end of the popular diabetes drug. Restricted access means among other things that:

• in order to prescribe the drug doctors must be part of a registry that certifies that they are familiar with the cardiac risks involved with the use of Avandia
• they are prescribing it only because their patient has exhausted all other medications to try and control their blood sugar
• patients also have to understand the cardiac risks involved in taking the drug 

Patients currently on Avandia should be hearing from their doctor’s office soon to discuss their use of Avandia. If they don’t they should give them a call. bjmdjd

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Avandia · diabetes · European Medicines Agency · FDA

Well, it appears that the Salmonella outbreak traced to two egg farms in Iowa may be over. The topic has certainly gotten plenty of press on the national news. While the two farms are not shipping eggs to consumers at the present, the FDA report on what they found at the farms is sickening.

According to Medscape from WebMD Health News: “Among other things, FDA investigators found:

• Huge manure pits open to outside animals.
• Evidence that rodents, wild birds, and other animals could enter the hen houses via missing siding and gaps in doors and walls.
• Actual sightings of rodents, birds, and bird nests inside the facilities.
• So many live flies that they were crushed underfoot on walkways. Maggots “too numerous to count” were seen in at least one manure pit.
• Farm workers went from hen house to hen house without cleaning their tools or changing their shoes or clothing — which can spread germs between houses.
• Uncaged birds tracked manure from the pits to the laying houses.”

Eggs are still being sold to food makers who use them in their products but they are sterilized during processing. Let’s see…do you want scrambled or over easy? Or maybe some raw cookie dough. bjmdjd

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eggs · FDA · Food and Drug Administration · Iowa egg farms · Salmonella

First, let me apologize for the two week break between posts. Frankly I haven’t come across much that I thought you needed to know and I’m determined not to post just for the sake of doing it.

Now to the meat of the matter. It is too early to be giving much thought to the flu vaccine here on the 1st of August. What got me to thinking about it is the fact that the Food and Drug Administration announced on Friday that they had approved which strains will be included in the vaccine for the upcoming flu season. This years vaccine will include the H1N1 strain that everyone had trouble deciding whether to get or not in a separate vaccine last season.

I was planning on listing some great info on the flu vaccine on this post but I found a release by the FDA which you can read by clicking on the following link: http://www.cdc.gov/flu/protect/keyfacts.htm   bjmdjd

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flu season · flu vaccine · Food and Drug Administration · H1N1 · health · influenza · wellness

The FDA advisory panel which met to determine the safety of the diabetes drug Avandia has voted 20 – 12 to keep the drug on the market despite concerns over posiible cardiac risks. 10 members also recommended limiting who can prescribe the drug and who should be allowed to take it.

The FDA has promised to review the findings of the panel and make their decision as soon as possible. While they do not have to follow the recommendations of the advisory panels they usually do. bjmdjd

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Avandia · Food and Drug Administration

The possible heart dangers of the diabetes drug Avandia are in the news again. An FDA advisory panel is in the midst of a two day hearing on the drug and it’s possible cardiac dangers.

More evidence has surfaced that suggests that the drug manufacturer (GlaxoSmithKline) knew about the possible heart risks as early as 2001 but withheld the information. The company claims that the information concerning them withholding cardiac risks was “cherry picked” from nearly 14 million pages of documents and is untrue.

If you take Avandia you need to pay close attention to these hearings. A decision will eventually be made that could range from stronger warnings on the drug label to possible removal from the market. bjmdjd

Material modifications since posting: July 16, 2010

Avandia · Food and Drug Administration · GlaxoSmithKline