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

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