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

Material modifications since posting: none

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

Material modifications since posting: none

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

Material modifications since posting: none

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

Folks taking the antidepressant Effexor will be happy to hear that a generic form of Effexor XR was approved by the Food and Drug Administration this week. Teva Pharmaceuticals announced that they will begin shipping the drug on July 1, 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

Material modifications since posting: none

Food and Drug Administration · generic form of Effextor XR · health · Teva Pharmaceuticals · venlafaxine hydrochloride · wellness

The Food and Drug Administration appears to be earning its pennies this week. They have issued several warnings/recommendations that are important. I feel the need to write about the doings of the FDA because most patients will never hear about these warnings on medications that they may already be taking.

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

Food and Drug Administration · fracture risk · orlistat · proton pump inhibitors · severe liver injury · suicide risk · tramadol

For many years it was felt that nuts were an unhealthy snack. More recently many kinds of nuts have been found to be better for you than originally thought.

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

Material modifications since posting: none

Archives of Internal Medicine · coronary artery disease · Food and Drug Administration · nuts can lower cholesterol

Back on 2/12/10 I posted an alert from the Food and Drug Administration about a recall of automatic defibrillators by Cardiac Science Corporation.

Today the FDA issued a warning once again concerning Cardiac Science defibrillators which fail to deliver a shock during resuscitation attempts and several other problems in their operation. Cardiac Science recalled various Powerheart and CardioVive models back in November 2009 but the FDA has now announced similar problems with various Nihon Kohden and GE Healthcare models prompting this warning.

Cardiac Science has updated some software associated with some of the defibrillators and plans others but the FDA says that these updates don’t solve all of the problems. bjmdjd

Material modifications since posting: none

automatic defibrillator · CardioVive · Food and Drug Administration · GE Healthcare · Nihon Kohden · Powerheart

An advisory panel recommended to the Food and Drug Administration last month that a ban on the use of tanning beds by anyone under the age of 18 be implemented. They stated that tanning beds are classified as class I medical devices which puts them in the same category as tongue depressors and elastic bandages which allows for very little over-site and regulation.

The American Academy of Dermatology has taken a strong stance against the use of tanning beds stating that skin cancer used to be a disease of older men but now it is becoming more common in young women in their teens and twenties. The exact sex and age group using tanning beds the most.

The tanning bed industry was well represented at the meeting saying that they were already well regulated and that there is much misinformation about tanning beds and their dangers.  Other recommendations concerning the use and regulation of tanning beds were also suggested. The FDA doesn’t have to take the advisory groups recommendations but they usually do. I guess that there are still plenty of smokers and cigarette industry reps who claim that there is no evidence that cigarette smoking causes lung cancer.  bjmdjd

Material modifications since posting: none

American Academy of Dermatology · Food and Drug Administration · tanning beds and skin cancer

I noticed that Katie Couric had a story on the salt/sodium intake of Americans on the “Evening News” last night.

The Institute of Medicine has asked the Food and Drug Administration to set new federal guidelines as to how much salt can be added to foods by restaurants, food and beverage service companies, and food manufacturers. The FDA is expected to make their decision soon after reviewing various information.

All parties concerned feel that as a country the U.S. has not had much luck in lowering the amount of salt/sodium intake in our foods. It is hoped that by requiring less salt in prepared meals and processed foods that total salt consumption will be greatly reduced.  bjmdjd

Material modifications since posting: none

Food and Drug Administration · Institute of Medicine · salt/sodium intake