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

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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

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

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

Material modifications since posting: none

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

On March 9th ABC news ran a story about the long term use of Fosamax or its generic forms causing sudden femur fractures just below the hip joint. The next day the Food and Drug Administration reported that it had no evidence to support this belief.

While the ABC report only mentioned the drug Fosamax and the generic forms called alendronate there are several other drugs marketed in this class of medications called biphosphonates for the prevention and treatment of osteoporosis. The FDA recommended that patients not quit taking these drugs unless told to by their medical provider.  bjmdjd

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ABC News · alendronate · biphosphonates · Food and Drug Administration · Fosamax · health · wellness

The Food and Drug Administration (FDA) today approved the use of Botox for the treatment of increased stiffness and tightness in certain muscles of the upper extremities in patients with conditions like traumatic brain injury, stroke, and progressive multiple sclerosis.

They also reiterated that the treatment is not meant to be a substitute for physical therapy and rehabilitation and that there are many possible serious side effects with its use.  bjmdjd

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It looks like Medicare patients and the physicians that see them may be safe again for a while. The Senate today voted to delay the 21.2% Medicare physician pay cut until October 1, 2010. It will take effect if the House approves it and President Obama signs it. Both which will probably occur.

This is the same bill with extending unemployment benefits attached to it and extension of premium subsidies for those who are out of work under the COBRA program. Most Democrats voted for it in the Senate and most Republicans voted against it under the guise of not wanting to increase the deficit.

As I wrote earlier, I understand and agree with the deficit problem but the unemployed need some money to exist and Medicare patients need to be able to get an appointment to see their doctors. Hopefully Congress will finally create a permanent fix for the Medicare physician reimbursement problem that they have had to frequently cover with a band aid.  bjmdjd

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The results of two different studies that were scheduled to be presented today at the annual meeting of the American Academy of Orthopaedic Surgeons detail the high rate of severe injuries to children who ride all terrain vehicles (ATVs). These injuries include spinal injuries, amputations, and even death.

A pediatric emergency medicine specialist at the Cincinnati Children’s Hospital who was not involved in the studies said that ATV associated deaths increased almost 60% from 2000 to 2005 and non fatal accidents increased 48%. People, kids and adults, love them but these studies only reiterate what those of us in medicine already knew.  bjmdjd

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all terrain vehicles · American Academy of Orthopaedic Surgeons · ATVs · Botox · Food and Drug Administration · health · Medicare physician pay cut · muscle tightness and stiffness · Senate · wellness

For you gazillion men who are taking Flomax to treat your enlarged prostate you will be pleased to know that the first generic form has been approved by the Food and Drug Administration.

A California based company will be producing the first generic version of Flomax and the prescribing information and side effects will be the same as for the brand name version. You will notice one big difference though…the price! While the new price has not been announced you can bet it will be drastically cheaper.

Even though the patent for Flomax does not expire until April 2010 the new generic version is expected to be on the market this month.  bjmdjd

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Food and Drug Administration · generic Flomax · health · wellness

The heartburn drug Kapidex was approved for use in the United States in January 2009 for patients suffering from gastroesophageal reflux disease and has become very popular. However, according to the Food and Drug Administration (FDA), pharmacists are frequently confusing Kapidex with the prostate cancer drug Casodex and the narcotic pain reliever Kadian.

For this reason starting next month Kapidex will be renamed and called Dexilant. The FDA said that they have no other problems with the drug other than the confusion caused by its name.  bjmdjd

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Casodex · Dexilant · Food and Drug Administration · health · Kadian · Kapidex renamed · wellness

On Saturday the New York Times published an article concerning the possible cardiovascular risk to patients taking Avandia for diabetes. This has been in the news for sometime now but until recently had died down. The concern is whether taking the drug raises the user’s risk of having a heart attack or developing heart failure. 

Today the Food and Drug Administration (FDA) released a report saying that they were reviewing clinical study results and observational studies to determine if Avandia posed a big enough risk to be removed from the market. They stated that no conclusions or recommendations had been reached at this time but they planned to release their findings at a public meeting in July.

Meanwhile, the FDA suggests that all patients continue to take their Avandia unless they are told to stop by their doctor.

A bipartisan Senate investigation of the situation reported that GlaxoSmithKline, makers of Avandia, are responsible for the drug’s current problems because they failed to alert patients for years concerning the drug’s dangers. So the Avandia debacle continues as does the many woes of the Food and Drug Administration. I don’t mind admitting that BEFORE all of this hit the news many months ago, I was taking Avandia.  bjmdjd

Material modifications since posting: 7/14/2010 and 7/16/2010

Avandia · danger of Avandia · diabetes · Food and Drug Administration · GlaxoSmithKline