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

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

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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

I never really understood why we needed to be warned not to operate a bulldozer after taking medications that make us sleepy! But then again most every physician has heard of the pregnant women who had their partner take their birth control pills for them for a few days or they spread contraceptive jelly on toast and ate it. I guess instructions are just not obvious or understandable to everyone.

This week the Food and Drug Administration issued a warning not to swallow Benadryl Extra Strength Itch Stopping Gel meant to be spread on the affected skin. The problem is in getting too large of a dose of the active ingredient diphenhydramine. Large doses can cause confusion, unconsciousness, and hallucinations.

I guess that I just like to assume that common sense and reading/understanding simple instructions are a common thing. I guess it is the folks that don’t fall in this category that help keep the plaintiff attorneys (and the FDA for that matter) in business. bjmdjd

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Benadryl · diphenhydramine · Food and Drug Administartion

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

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

Well, it looks like there is another quick fix on the market for those who want the easy way out when it comes to being over weight. The Food and Drug Administration has sent warning letters to six medical spas in the U.S. and a Brazilian company that makes the product about misleading or false statements made online about drugs claimed to eliminate fat in a procedure called “lipodissolve.”

The Brazilian company’s website now claims that they no longer sell the drugs used in the procedure. The FDA says that there is no evidence to support any of the medical uses that the spas and manufacturer claim. As a matter of fact there have been many adverse reactions, some serious, to the use of these injectable drugs.

The spas in the U.S. are located in Pennsylvania, Idaho, Maryland, Minnesota, Florida, and Indiana. 

It appears that the best way to fight the fat fight is to exercise and push away from the table! bjmdjd

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fat dissolving product · Food and Drug Administration · lipodissolve

The Food and Drug Administration has issued a recommendation that doctors stop using GlaxoSmithKline’s rotavirus vaccine called Rotarix until more studies can be done.

While the FDA says that they don’t believe that there is any clinical risk to patients a pig related virus has been discovered in the vaccine. The virus is not known to cause illness in either humans or animals.

This alert DOES NOT include Merck’s vaccine called Rota Teq which most infants vaccinated in the U.S. receive anyway.

Rotavirus is an illness that can affect infants causing diarrhea and dehydration.  bjmdjd

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Food and Drug Administration · Rota Teq · Rotarix · rotavirus