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

As I predicted the Medicare disaster that I wrote about on 2/27/10 was averted when President Obama signed a bill postponing the physician pay cut of 21.2% until April 1st. Kentucky Senator Bunning had the bill held up along with several important attachments (like the unemployment benefits extension) until the Democrats could prove to him that they had a way to pay for it.

Organized medicine is still not pleased. There is something called the sustainable growth rate formula that is used to determine Medicare reimbursement rates for physicians. This formula is the reason that these pay cuts come up frequently and the congress has to waste time repealing or postponing them which is always what they end up doing. While this is responsible on their part and needs to be done, they could avoid the entire issue by permanently repealing the formula. Organized medicine has begged for this for some time.

Anyway all is well for the time being and hopefully congress will come up with a more permanent fix to the problem before April 1st. And hopefully Medicare patients will be able to get doctors appointments between now and then.  bjmdjd

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health · Medicare physician pay cut · President Obama · Senator Bunning · sustainable growth rate formula · wellness

All the talk now is how expensive healthcare has become and the costs seem to be rising every day. The National Heart, Lung, and  Blood Institute has released some numbers that are staggering.

Below are the estimated direct and indirect 2010 costs (in billions…that’s with a “B”) in  the United States for the five most expensive diagnostic groups:

• $324.1 billion     Cardiovascular Diseases
• $225.2 billion     Digestive System
• $177.7 billion     Mental Health
• $175.4 billion     Nervous System
• $172.9 billion     Injury and Poisoning

As Healthcare Reform possibly looms in our future it’s important to remember what the real numbers are!  bjmdjd

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health · healthcare is expensive · Healthcare Reform · National Heart Lung and Blood Instutute · wellness

The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices has voted to recommend that all adults receive the annual influenza vaccine beginning next flu season (2010 – 2011). Prior to this recommendation the focus was on people between the ages of 6 months and 18 years old and over 50 years old, anyone at risk of complications from the flu, and those in close contact with high risk individuals.

Now the new recommendation encourages everyone over the age of 6 months to be vaccinated unless they have a contraindication. Since vaccine makers have plenty of lead time for planning an increased manufacturing schedule it is hoped that the increase need for vaccine will not cause a shortage.  bjmdjd

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Centers for Disease Control and Prevention · flu shot · flu vaccine · health · universal flu vaccine recommendation · wellness

The Food and Drug Administration announced today that the makers of asthma medications containing long acting beta agonists (LABAs) must add to the labels that patients should not take drugs containing the LABAs on a long term basis unless their symptoms cannot be controlled on another medication such as an inhaled steroid.

The labels must also contain the information that LABAs should never be used alone in the treatment of asthma. Most patients, both adults and children, receive these LABAs in combination with a steroid such as in the meds Advair and Symbicort.

Patients who gain control of their asthma symptoms on these combination preparations should be changed to an inhaled steroid alone or some other medication without LABAs added.  bjmdjd

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Advair · asthma · Food and Drug Administration · health · long acting beta agonists · Symbicort · wellness

After not having posted anything for a few days I came across some information last night that I couldn’t resist. I noticed an ad in one of the many medical magazines/journals that I read on a regular basis for a new medication that I didn’t remember ever seeing mentioned before. It was for a drug called Colcrys.

The interesting thing about this “new” medication is that it is really just plain old colchicine. That’s a med taken for many years for people who suffer from the painful condition known as gout. For years it has cost about 10 cents a tablet at an average monthly cost of about $6.00 per month. Colcrys is about $5.00 a tablet with an average monthly cost of about $300.00. How is this formulation different from the cheaper generic form? It’s not. It’s the same thing!

Why would any patient in their right mind choose the more expensive form? Well, they may not have a choice. You see colchicine falls into a class of drugs called “unapproved” rather than “generic” because it is so old that it predates the law that requires drugs to be approved by the Food and Drug Administration. The FDA has been encouraging drug companies to get these drugs approved by doing studies and in turn the governing organization will offer some perks such as removing some unapproved drugs from the market. This would give these drug companies sort of a monopoly on these old drugs if you will.

This is what has happened with colchicine. Now that they have done the studies to have their form of the drug “approved” the drug manufacturer that makes the “new” expensive form of colchicine is hoping that all other forms of the med (i.e. the inexpensive forms) will be removed from the market and that theirs will be the only one available. It is not mandatory that the FDA remove all of these “unapproved” forms of the drug from the market but they can if they decide to.

The manufacturer of Colcrys is not waiting for the FDA to act so they have filed suit against the other 4 manufacturers of the older forms of colchicine. Assuming their eventual fate 3 of those 4 companies have already stopped making colchicine. In order to keep the price of colchicine from sky rocketing both physicians and patients need to contact the FDA and let their opinions be known.

You can do so in writing by contacting the FDA Commissioner Dr. Margaret Hamburg at margaret.hamburg@fda.hhs.gov or the director of the FDA Center for Drug Evaluation and Research Dr. Janet Woodcock at janet.woodcock@fda.hhs.gov. Good Luck!  bjmdjd

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colchicine · colchicine price increase · Colcrys · Food and Drug Administration · generic drug · health · health news · healthcare · unapproved drug

I’ve read a couple of studies recently that reminded me about something very important that I have never mentioned in this blog. Are supplements and so called “natural” medications safe? The answer? They may be and they may not be. That really helps.

The real problem is that many people feel that any medication that can be purchased without a prescription and is called a supplement or “natural” is completely safe. This is absolutely untrue!

I feel that the main problem with many supplements is that no well designed and reliable studies have been done to determine the effectiveness and possible harmful side effects and drug interactions of these medications. They are not regulated by any governing agency. Even though the Food and Drug Administration does occasionally make a mistake when evaluating prescription medications, they have absolutely no control over the manufacture or distribution of these supplement medications.

Another problem with supplements or “natural” medications is that the correct dosages are not really known and with no regulation you really don’t know how much of the medicine you are actually getting in the manufacturers formulation. Maybe it says 500 mg but is it really? Who knows?

The bottom line…be very careful with the use of supplements and “natural” medicines. Many people complain about the cost of healthcare but they gladly purchase these expensive medicines with out of pocket money when they don’t even know if they are helping or hurting them. Because of possible prescription drug interactions you should always inform your doctor of any of these medications that you are taking.

Be very careful with anything that you put in your body.  bjmdjd

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are supplements safe · Food and Drug Administration · health · healthcare · natural medicines · supplements · wellness

No doubt one of the worst things that can happen to a person is to lose a child. It’s terrible no matter what the cause but it’s especially bad when the loss is unexpected like with Sudden Infant Death Syndrome (SIDS). SIDS is defined as the unexplained death of an infant within a year of birth. There is often times guilt on the part of the parents because the true cause of SIDS is not known.

A new study reveals that infants who die from SIDS have an unusually low level of the chemical serotonin in the brainstem portion of their brain. This affects responses to breathing and carbon dioxide, temperature, heart rate, and blood pressure. There has long been a link between low serotonin levels and autism. It has even been speculated by some that the babies that live with these SIDS risk factors through the high risk period might be the children that develop autism in later years. It does seem in some studies that the increase in the diagnosis of autism followed a decrease in SIDS deaths.

It is hoped that this information along with other studies can help identify infants who might be a risk of dying from SIDS. It is no doubt multifactorial including the factors listed above along with sleep position and even exposure to cigarette smoke. Several risk factors are felt to be needed for SIDS to occur and the more that are present increases the likelihood of the condition occurring.  bjmdjd

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autism · health · healthcare · serotonin · SIDS · Sudden Infant Death Syndrome · wellness

Well…FINALLY! A United Kingdom regulatory panel has ruled that the doctor who led the study linking autism and the MMR vaccine acted “dishonestly and irresponsibly.” It started a worldwide panic among parents and led to an increase in measles due to a decrease in vaccinations. The ruling was only on the actions of the physicians involved in the study and not on the autism question.

The original study was published twelve years ago and in 2004 ten of the study’s thirteen authors rejected the findings. This week the medical journal (The Lancet) that originally published the study retracted it after finding out that the lead researcher had accepted money from lawyers suing vaccination manufacturers even before he designed the study.

Even with all of this there is still a very active movement around the world to convince parents that the vaccination – autism link is real. Celebrities such as Jenny McCarthy and her actor significant other Jim Carrey have made it their cause.

Whether or not you believe that this controversial topic is true or not there is now little doubt that the original study was a sham. There have been numerous studies since that have shown no link but many parents are convinced and it has led to a dangerous decrease in vaccination rates.  bjmdjd

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autism · health · healthcare · MMR vaccine · vaccination rates · wellness