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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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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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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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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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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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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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

Teva is the world’s largest generic drugmaker and hopefully the generic form of Effexor XR will be a big relief for its users pocket books. bjmdjd

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This week the FDA issued a warning concerning the possibility of severe liver injury with the use of a popular weight loss drug called orlistat. The 120mg formulation is prescription only and is marketed as Xenical and the over the counter 60mg formulation is Alli. This warning is based on reviews being done by the agency since last August and involves 13 patients with severe liver injury. Some died and some required liver transplantation.

The agency also issued a warning concerning a suicide risk with the use of tramadol. Tramadol is a pain reliever marketed as Ultram and as Ultracetwhich is tramadol with acetaminophen. It is recommended that it not be prescribed to patients who are suicidal or addiction prone and to be cautious with patients who use alcohol excessively, are depressed, or take tranquilizers or antidepressants.

The FDA also issued a recommendation that physicians exercise caution in prescribing proton pump inhibitors due to evidence that high doses or long term use of these drugs may increase the risk of various fractures. These gastroesophageal drugs include both the prescription and over the counter formulations of Prevacid, Nexium, Prilosec, and Zegerid. While the studies are not conclusive the FDA is working with the various drug manufacturers to further examine the risk.

One of the things that bothers me about the above FDA concerns is that some of these drug formulations are over the counter and there is nothing stopping patients from misusing these medications and further exposing themselves to more risk. If you are taking any of these drugs it might be wise to at least discuss it with your physician.  bjmdjd

Material modifications since posting: On May 27, 2010 Krishan Maggon PhD was kind enough to let me know via Medpedia that the Food and Drug Administration can recommend label changes on over the counter drugs so that the warning is on the package. Thanks for your contribution Dr. Maggon. bjmdjd

A recent study published in the Archives of Internal Medicine revealed that eating almost any kind of nut lowers total cholesterol levels and the bad kind LDL. The amount of lowering was found to be dependent on how many nuts were consumed. The authors of the study said that the risk of coronary artery disease was almost 40% lower in folks who ate at least four servings of nuts per week compared to those who rarely or never ate them.

It does seem that the benefits of eating nuts on cholesterol lowering was better in those who started with higher cholesterol levels. This study seems to support the 2003 statement by the Food and Drug Administration that the consumption of certain types of nuts might lower the risk of heart disease. The nuts mentioned at that time by the FDA included almonds, hazelnuts, pecans, pistachios, walnuts, and peanuts.  bjmdjd

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