The World’s Smallest Cardiac Pacemaker

April 21st, 2014  |  The Blog

Cardiac pacemakers save lives. That is a fact. The traditional cardiac pacemaker is placed in the upper left chest with wires or leads threaded into the heart, where the pacing occurs. The traditional device is a visible and palpable under the skin on the chest wall.

All that is about to change with the debut of the newest, smallest pacemaker, Medtronic’s Micra Transcatheter Pacing System (TPS). This new device will change the world of the cardiac healthcare industry.

The Specifics of the Device

The Transcatheter Pacing System is small, in comparison to the traditional device. It is 1/10th the size of a traditional pacemaker or about the size of a nickel or 5-cent coin. The new device is an all-inclusive, one piece system with no generator or traditional wires or leads. It has a long, 10-year, battery life.

The new pacemaker is implanted through the femoral vein via catheter and is placed inside the heart.

The Benefits of TSP

There are many benefits to the new cardiac pacemaker, which include some of the following:

  • The TSP is a smaller size device, which is not visible on the chest wall.
  • There is no surgical incision on the chest wall, unlike the surgical pocket needed to hold the traditional pacemaker.
  • This pacemaker does not require the traditional surgical procedure, which carries its own risks. Placement of the TSP requires a minimally invasive procedure.
  • This pacemaker eliminates leads or wires threaded from the traditional device into the heart.
  • It performs the same functions as the traditional system.
  • Without the surgical incision or wires, the risk of infection is reduced.
  • There is increased safety, improved patient comfort and better patient satisfaction without the traditional rigid device in place on the chest wall.
  • The TSP reduces the recovery time of traditional pacemaker procedure.

How the Device Works

The TPS is placed inside the heart via a femoral vein catheterization. The tiny pacemaker attaches onto the endocardial tissue or heart wall with tines. It can be repositioned within the heart, if needed.

Pacing signals or the delivery of electrical impulses that pace the heart rate are sent through the electrode tip at the end of the implanted device.

The End Result

The Medtronic?s Micra Transcatheter Pacing System brings implantable cardiac devices to a whole new level. Both the patient outcomes and device efficiency are significantly improved with this cardiac device update and new technology.


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3-D Printing Changes Lives

April 14th, 2014  |  The Blog

Getting a new printer has just gone to a whole new level. The 3-D printer can make wonderful arts and crafts projects but it can also produce so much more. That so much more has to do with life-changing health issues.

3-D printing, also called additive manufacturing, is changing the medical world in several ways. The printed objects are used in real time and also used as prototypes for practice and to fine-tune upcoming complicated surgical procedures.

3-D Printing Explained

3-D printing technology and uses have dramatically changed and multiplied over the past several years. The high-resolution, plastic 3-D models, some of which provide down to 16 microns accuracy or the size of a miniscule droplet in a cloud, are works-of-art.

Since a variety of materials can be used to mimic the different structures in the body like bone, skin and blood vessels, the 3-D printer has many applications. The 3-D renditions are printed from a patient’s computed tomography (CT) scan images. This helps to capture the unique anatomy of each patient.

Who makes 3-D printers?

There are several companies who provide this 3-D capability with their product. Two popular manufacturer options include:

  • MakerBot
  • Adobe, which added a 3-D program to Photoshop

There are also companies, such as Shapeways, from which a client can order completed 3-D printing services.

How It Works

The actual 3-D printing is done this way:

  • Printable objects are designed by a special program
  • The printer lays down consecutive layers of material like plastic, ceramics or metals, from bottom up
  • A different section of the program slices the object into many layers, which are then placed in specifically programmed areas of the end product
  • 3-D object is finished

Benefits of the 3-D Printer

There are many uses and benefits for 3-D printing. They include:

  • Provides a means for medical procedure simulation and increased preparedness for a complicated procedure. Especially helpful in complicated, convoluted cases like a hemispherectomy (brain surgery for epilepsy patients) and vascular procedures involving veins and arteries
  • Allows training and practice on the actual anatomy of a patient before a sensitive surgical procedure. That is, practice on an accurate 3-D model before performing the surgery
  • By actually holding a 3-D model of a patient’s actual anatomy, surgeons can pre-plan their surgical approach and equipment needs (like the catheter size before a catheterization)

Some healthcare facilities are making 3-D printed models as standard protocol for every patient being treated in their clinic. This is especially popular in cerebrovascular surgery centers. Many physicians call this capability the cutting edge of neurosurgery. It makes impending surgery safer and minutely accurate.

3-D Uses

The 3-D printer has been used for many different things, some of which include:

  • Skulls, brains and neurological vessels
  • Pelvis
  • Prosthetic hands
  • Ear organs
  • Windpipe (breathing tube)

A Supported Windpipe

A population of babies have benefited by 3-D printing. Fragile, underdeveloped windpipes are supported by a flexible, plastic 3-D splint to hold the airway open until it is strong enough to work on its own.

A Look at the Prosthetic Hand

A prosthetic hand is exorbitantly expensive, especially as a child grows and the hand needs to be adjusted to their changing body size. Depending upon the quality of the prosthetic, the cost can be $10,000-$80,000. Many patients cannot afford the cost.

Out of financial necessity, the dad of a young son became inventive and created a $5.00 prosthetic hand. The $5.00 covers the materials to actually print the hand. Then, add on $150 in other necessary parts. This is still a real bargain, thanks to their MarkerBots 3-D printer. Every new hand requires 3 or 4 printings, each of which takes one to two hours to print. Each new version of the hand has better capabilities.

The Future

There is a website called, where there are designs for toys, mechanical parts and medical devices in the 3-D printer world. This is the cutting edge of the future in some medical fields.



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A Cancer Registry

April 7th, 2014  |  The Blog

So, you are with a patient, friend or family member or caring for a patient when they get the news. They have cancer. It does not matter where the cancer is located or what stage of cancer the doctor tells them. The fact is that, they have cancer. What now?

A patient’s response to getting the news of a newly diagnosed or recurrent case of cancer varies but is most often not a happy one. No one ever wants to hear those words.

The Survey

A group of breast cancer patients being treated at Massachusetts General Hospital, in Boston, MA, recently participated in an online survey to discuss their emotional response to receiving the news that they have the dreaded disease. Their participation has brought this survey option to light.

Cancer Patient Registry

The online survey is called the Cancer Experience Registry. The link to the site is:

A non-profit patient advocacy organization, the Cancer Support Community, manages the registry. The site has been up and running for nearly one year. There are over 6,000 cancer patients registered in the national registry.

Personal information from the survey is not publicly shared. Researchers analyze the information and the general results are shared with the medical professionals caring for cancer patients.

The hope is that the information from the surveys will provide the healthcare community with information about where in the cancer care process there is a lack of patient support and information.

Patient Response

The purpose of the registry is to encourage cancer patients to share their personal experiences with cancer.

The survey takes each patient 30 to 45 minutes to complete. The questions posed to the patient include information about:

  • Diagnosis
  • Treatment
  • Ongoing symptoms
  • Level of emotional support

The Cancer Experience Registry site plans to add a caregiver’s section by June 2014. This will add another and very necessary dimension to bettering the care of cancer patients.

The Survey Outcome

The three main results, so far, show the following:

  • 54% of the patients wished that they had more support to deal with the emotions associated with a cancer diagnosis
  • 58% of the participants wished they had more help dealing with the long-term side effects of cancer like fatigue and anxiety
  • 41% of the patients documented that engaging in sex since their cancer diagnosis has added a source of distress to their life

The registry will ultimately benefit the greater community of cancer patients and survivors. The information collected will serve to give healthcare providers the data they need to improve the overall physical and emotional well being of their patients. Questions that are not asked in a routine office or clinic visit are found on the survey. This survey goes beyond the routine clinical questions and looks at the personal and emotional aspects of a cancer diagnosis.


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Ramping Up to Opening Day

March 31st, 2014  |  The Blog

As the Major League Baseball (MLB) season ramps up, the baseball world is evaluating and tweeking the nutrition status of its players. You are what you eat, or that is what they say.

Let’s take a look at what the sports nutrition experts, specifically those working with the Boston Red Sox, suggest for the pros. There are a few simple and valuable lessons to learn.

First, the main do not’s:

  • Do not buy into fad diets. They are not the answer to good nutrition and weight loss.
  • Avoid fast food restaurants. Stick with restaurants that are known to offer healthy options.
  • Avoid oil-based sauces.

Now, the main to do’s:

  • Add in strength training and conditioning. Both are important additions to augment a balanced diet.
  • Eat fresh vegetables.
  • Cut back on the amount of salad dressing. Use fresh spices for added flavor.
  • Order dressing on-the-side.
  • Enjoy grilled lean protein choices like fish, chicken breast, steak with lower fat content (top round or sirloin are good choices).
  • Snack on healthy choices like an apple and yogurt.
  • Sweets are okay but do not consume more than 10% to 20% of daily calories on sweets.
  • Eat slowly.
  • Chew well, smell and taste the food. This helps to avoid overeating because the brain has time to process the stomach’s signal that it is full.

Nutrition supplements:

The MLB has a pretty strict policy of what is allowed, with regard to nutrition supplements. Allowable supplements must be stamped with NSF International’s NSF Certified for Sport Program seal. This guarantees that the product was tested and does not contain any banned substances.

While the public sector need not be quite as vigilant about the MLB nutrition rules and suggestions as the players, it is wise to follow their healthy and substance-free choices. The general philosophy is this: the best way to get nutrition, specifically vitamins and minerals, is through fortified foods, not supplements.

The MLB nutrition team offers these relatively simple and healthy diet tips:

  • Eat more plant-based food.
  • Avoid processed foods like protein bars.
  • A simple, everyday substitute for the ever-popular protein bar, of which there are 100?s of choices, is simple. Eat a peanut butter (PB) and banana sandwich on whole wheat bread or a selection of fresh fruit and nuts.
  • Keep it simple. Keep it real. Keep it healthy.

The end result of eating fresh fruits, fresh vegetables and nuts, according to the MLB nutrition specialists is:

  • Less illness
  • Fewer injuries
  • Better playing on the baseball field

With the baseball season close to starting, aka Opening Day, perhaps the fans should also take an important lesson from the sports nutrition specialists who guide the players of America’s favorite pastime. Make the right food choices and eat healthy. Play Ball!

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Menopause Symptoms 101

March 24th, 2014  |  The Blog

Menopause is the end of a long hormonal journey for women. At this time, menstrual periods stop. This transition is accompanied by some other physical changes of the body and their associated, and sometimes bothersome, symptoms.

Once menstrual periods stop for one full year, a woman is considered to be post-menopausal. How do women get to the other side of menopause? Every woman experiences different symptoms, which can include:

  • Hot flashes
  • Night sweats
  • Sleep disturbance
  • Vaginal dryness
  • Low libido
  • Mood swings
  • Headaches
  • Thinning hair
  • Acne
  • Mental fogginess

How to Deal With the Symptoms

Here is a look, one-by-one, at each aforementioned menopausal symptom and how to deal with it.

Hot flashes

First, keep track of what might initiate an episode; write it down. Does caffeine, stress, alcohol or an overheated room set off a hot flash. Take slow, deep breaths, in through the nose and out through the mouth to help a hot flash pass.

Night sweats

A typical hot flash during the night can last about 3 minutes. If night sweats are becoming routine, switching to lighter PJs will help. A lighter blanket and a tabletop fan will also help reduce the frequency of the episodes.

Sleep disturbance

There are a few ways to increase and enhance sleep. Meditation, including yoga and tai chi, can help with relaxation. Regular exercise helps but be sure to stop exercising 3 hours before bedtime. Drinking warm milk, which contains tryptophan, induces sleep.

If it is hard to fall asleep, get out of bed and read until sleepiness sets in.

There is one do not that affects sleep: skip any alcohol before bedtime. It actually causes sleeplessness later on in the night.

Vaginal dryness

Menopausal hormone changes cause the vagina to become dryer and develop a thinner wall. This can result in painful sex. Water-based, over-the-counter vaginal lubricants can help. There are also prescription-strength hormonal vaginal creams and rings that can be used.

More frequent sex increases the blood flow to the vagina, which also helps reduce the overall complaints.

Low libido

This is a common symptom of menopause. Making time for sex, amid everyone’s busy life and schedule, will help. Discuss the issue with a physician to rule out any other physical causes.

Mood swings

There has been a link found between bad PMS (premenstrual syndrome) and more severe mood swings during menopause. Low dose birth control pills (BCP), antidepressants and other medications can help relieve the symptoms.


Migraines can increase during menopause or appear for the first time. Keeping a diary of what triggers a headache can help to avoid or, at least, relieve them. Some common triggers include: hunger or lack of sleep.

Thinning hair

A woman?s hair can shed or thin faster during menopause. That is a bad enough consequence but hair can also appear in unwanted places. Some women find hairs on their chin or cheeks. A few things can be done to try and preserve hair: use hair color without harmful chemicals and avoid the sun, which causes drying.

Facial hair can be bleached, plucked, waxed or lasered away.


Using gentle, oil free face products, including moisturizer, sunscreen, cleansers and make-up, will pamper aging skin.

Mental fogginess

Interestingly, women who experience more hot flashes also report more memory issues. It is important to challenge the brain function to keep it sharp. Lowering the stress level can help curb mental fogginess and fuzzy thinking.

It is important to discuss any long-term menopause-related concerns with a physician.


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Weight Loss and Atrial Fibrillation

March 17th, 2014  |  The Blog

Atrial fibrillation affects 2.3 million Americans. There are 200,000-300,000 new cases of atrial fib diagnosed every year in the U.S. An estimated 12 million people will be diagnosed every year by 2030. Why the spike? Simply stated, the rate of obesity in America.

Atrial Fibrillation 101

Atrial fibrillation is a cardiac arrhythmia, which translates into an irregular heartbeat. The two upper chambers of the heart, the atria, beat in a fast, disorganized and irregular manner. It is an electrical conduction problem.

The Symptoms

Atrial fibrillation symptoms vary among patients but most commonly include some of the following:

  • Heart palpitations
  • Shortness of breath
  • Dizziness
  • Fatigue
  • Weakness
  • Fainting
  • Chest pain

This arrhythmia usually delivers uncomfortable physical symptoms for the sufferer. It also increases the risk of stroke and other cardiac problems.

The Risks

The U.S. Centers for Disease Control and Prevention (CDC) consider the body-mass index (BMI) to be a good indicator for overall weight management.

Atrial fibrillation is greatly impacted by body weight. The newly recognized body weight risks, specifically the person’s BMI, revolving around atrial fibrillation include:

  • Overweight or a BMI over 25
  • Obesity or a BMI over 30

Interestingly, there is a 4% to 5% increased risk of atrial fibrillation for each 1-point increase of a person’s BMI. Clearly, being overweight has an impact on the function of the upper chambers of the heart.

Obesity also increases general inflammation in the body, which can cause thickening of the wall of the heart. This leads to less efficient heart function and an increased risk of developing atrial fibrillation.

Overweight people suffer from sleep apnea, hypertension or high blood pressure and metabolic syndrome. These factors each increase the risk of developing atrial fibrillation.

Other risk factors for developing atrial fibrillation include:

  • High blood pressure
  • High cholesterol
  • Diabetes
  • Coronary artery disease
  • Heart attack
  • Infection
  • Heart valve problems

The Treatment for Atrial Fibrillation

Popular treatments for atrial fibrillation include medications, electr0-cardioversion and/or a cardiac ablation procedure.

The newest treatment recommendation for atrial fibrillation is, depending upon the person’s BMI:

Lose an average of a little over 30 pounds

Many people who lost a significant amount of weight while awaiting an invasive ablation procedure never had to undergo the procedure. The weight loss was treatment enough to control their irregular heart rhythm.

The Result

Strict weight management resulted in a five-fold decrease in atrial fibrillation episodes. It is important to note that some people with atrial fibrillation are intermittently in the arrhythmia while others are constantly in the irregular heart rhythm. There were fewer and less severe episodes of atrial fibrillation reported by those patients who lost significant weight.

Patients who lost weight are less likely to need further procedures like an ablation to control atrial fibrillation.

Weight management, exercise and good nutrition are the basics of a generally healthy lifestyle. The addition of an atrial fibrillation diagnosis is a valid reason to imminently work on the weight management.

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Lice Should Not Be Scary

March 10th, 2014  |  The Blog

Lice. The word scares every parent, teacher and school nurse. In the big picture, what does it really mean?

Parents feel a true sense of embarrassment when they get that call or note from the school nurse stating that their child or some other child in the class has lice.

The tiny glossy lice eggs embed in the hair along the scalp surface. Most schools have a no-nit policy. Let the lice removal or picking begin.

One-third of cases with nits, when left untreated, continue on to have an issue with lice.

The Current Treatment

Most lice-treating products involve an initial shampoo treatment followed by a second medicated shampoo one week later.

The New Recommendations

Head lice pose no health threat to the individual, according to public health experts. The new thought is that a no-nit policy is unnecessary.

The American Association of Pediatrics (AAP) has voiced concern about young students unnecessarily missing a week or more of school under the current no-nit policies. The AAP has worked at getting schools to adopt the new, more liberal policy for over ten years.

The AAP makes their point about getting rid of the current school lice policies by stating that checking for lice on every child is futile. Schools do not routinely check for strep throat or chicken pox, both of which are more dangerous than lice.

The Solution

Some school systems have taken the new recommendation and discontinued the no-nit policies. How are lice findings handled?

  1. Infected students are sent home at the end of the school day with an informational note from the school nurse. This information includes two main components: The child is allowed to attend school. Children with adult lice should receive the standard shampoo treatment before returning to school.
  2. Some schools do not send students home midday but do not allow them to return to school until they are nit-free. The theory behind this is the fact that students might have been infected for weeks before the lice are discovered. The school nurse re-checks the student before they are allowed to re-enter classes.
  3. Some schools require that an empty bottle of lice shampoo be returned to the school nurse when they come back to classes.

Lice Resistance

Recent statistics show that about 60% of childhood head lice are resistant to over-the-counter chemical treatments, according to the New England Journal of Medicine.

Lice do respond to the newer treatments available, many of which are prescription strength. Malathion or Ovide is one such lice treatment. Unfortunately, many health insurance companies do not cover these treatments and they are costly, about $100 for a usual course of treatment.

Some health insurance companies require a child to undergo the readily available over-the-counter treatment before they will cover a prescription strength treatment. If lice survive the OTC treatment, some insurance companies will then pay for the prescription.

The Bottom Line

The earlier the treatment for lice begins, the more effective and the easier the situation is to control. Vigilance is a key factor. Parents should screen their children regularly, about weekly, for lice. Young children can be readily checked during bath time or when their hair is being combed or braided for school.



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Women and Stroke

March 3rd, 2014  |  The Blog

Anything but a stroke! That is the plea or prayer of the average member of today’s population. Having a stroke is usually life altering, not in a positive way.

Stroke affects 795,000 Americans every year. Of that number, 3% have survived the stroke with some residual health problems.

Stroke Effect

A stroke happens when blood suddenly stops flowing to the brain. A blood clot or an arterial rupture in the brain causes a stroke. About 20% of strokes are the result of an artery rupturing and subsequent bleeding in the brain.

Blood carries oxygen and nutrients to the brain. Without the blood, brain cells die.

The results of having a stroke can be devastating. The residual symptoms can include:

  • Impaired speech
  • Memory loss
  • Trouble swallowing
  • Weakness
  • Numbness
  • Paralysis
  • Pain

Men Versus Women

According to recent research studies, women suffer 53.5% of new strokes in America.

Stroke is the 3rd leading cause of death for women and the 5th leading cause of death for men. It is the 4th leading cause of death overall. There are over 77,000 deaths for women and over 52,000 for men each year. This statistic sets the sexes apart.

Women usually have more debilitating effects than men after suffering a stroke.

Women Are Unique

There are some life and health risks that put women in a unique situation and at a greater risk for stroke than men.

Unique risks for women:

  • Pregnancy complications
  • Taking oral contraceptives
  • Hormone replacement therapy
  • Atrial fibrillation

Common risks for women:

  • Migraines with aura
  • Type 2 diabetes
  • Obesity
  • High cholesterol

It is important to note that women who develop preeclampsia, a condition of dangerously high blood pressure or hypertension, during pregnancy have double the chance of having a stroke as they age than women who had a completely healthy pregnancy. Preeclampsia is most common during the third trimester of pregnancy.

Taking birth control pills can elevate blood pressure, especially in women 45 to 49 years old. High blood pressure increases the risk of stroke. A red flag marker for stroke is a woman who takes birth control pills and smokes.

Atrial fibrillation is a cardiac arrhythmia that increases the risk of stroke four-fold, especially in women 75 years or older. This irregular heart rhythm causes blood to pool and potentially clot within the heart.

Hispanic women have a history of having a stroke at a younger age than other populations. Obesity and high cholesterol play into this statistic. Black women also have a higher risk of stroke than Caucasian women.

Professional Recommendations

The American Heart Association (AHA) and the American Stroke Association (ASA) have recently released stroke prevention guidelines, specifically for women. These two groups report that the proper stroke prevention can prevent 80% of strokes in women.

The AHA and ASA stroke prevention guidelines include:

  • More accurate assessment of a woman’s stroke risk
  • Stroke awareness in a younger population
  • Low dose aspirin and/or calcium supplement for pregnant women or those who had high blood pressure in a previous pregnancy
  • Pregnant women with documented high blood pressure need to be treated with anti-hypertensive medications
  • Preeclampsia, a condition with high blood pressure during pregnancy, needs to be recognized as a stroke risk factor, even after pregnancy
  • Preeclampsia patients who are also obese, smoke or have high cholesterol should have early treatment intervention
  • Blood pressure should be screened before birth control pills are prescribed
  • Migraines with an aura plus smoking increases stroke risk; women should be counseled to quit smoking
  • Women over 75 years old should be screened for atrial fibrillation

Physicians need to focus on stroke prevention for women. Other recommendations include:

  • Stop smoking
  • Eat a nutritious diet
  • Have a conversation with attending physician about reducing stroke risk, especially blood pressure control

The Future

Population projections indicate that the female population will increasingly overtake the male population as time moves forward. Women also live longer than men. These facts increase a woman’s chance of suffering a stroke at some time during her life.


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CVS Bans Tobacco

February 24th, 2014  |  The Blog

Smoking stinks. Smoking is harmful to a person’s health. With those thoughts in mind, CVS has issued a ban on selling cigarettes and other tobacco products by October 2014. Tobacco products, in this case, include cigarettes, cigars and chewing tobacco.

CVS’s decision has been commended by President Obama as a powerful example, by the American Public Health Association as a historic decision and by the American Association of Cancer Research as a visionary move. Kudos to CVS!

The Marketing Strategy

Tobacco product displays in pharmacies and convenience stores are designed to maximize the visual presence and encourage impulse purchases, especially in those people who are trying to kick the habit, in whatever form their tobacco comes.

The Journal of Public Health recently published a study stating that children as young as middle school age are 50% more likely to start smoking if they see one of these visually tempting wall displays at least once a week, compared to those children who do not see such a display. The power of a visual cue is astounding.

The Reason

CVS’s decision to stop the sale of tobacco products is predicated on the argument that, anyone in the healthcare business should not be in the business of selling tobacco products.

Think about it…it is an oxymoron, of sorts.

The Outcome

CVS will surrender $4 billion annually in tobacco sales. This is an astounding sales revenue to forfeit.

It remains to be determined if this decision will result in fewer people smoking overall. It will, at least, make tobacco products a little more difficult to find. Although, keep in mind that gas stations and convenience stores will continue to sell the tobacco products.

Interestingly, 5 years ago, the City of Boston banned tobacco sales in all pharmacies. This impacted 85 retailers leaving 10% fewer retailers selling tobacco products throughout the city.

There are the doubters and the believers that CVS’s ban on tobacco products will impact the overall number of smokers in the U.S. The end result remains to be seen.

The Hope

Hopefully, other big chain pharmacies, like Walgreen, Rite Aid and more, will follow suit. If they choose to follow CVS’s lead, a greater impact will be realized.

Perhaps, corporate peer pressure will help. After the City of Boston imposed the tobacco ban 5 years ago, 79 other cities and towns across Massachusetts did the same thing. This demonstrated peer pressure at its best.

The general consensus of healthcare professionals and organizations that strive to reduce general tobacco use is this: the voluntary reversal of tobacco sale by CVS will impact other pharmacies to ban cigarette sales. Voluntarily deciding to stop selling tobacco products makes a bigger social statement than a mandate.

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Acetaminophen Concern

February 18th, 2014  |  The Blog

Acetaminophen is a common drug used to treat minor pain and reduce fever. It is found as acetaminophen alone and as an added ingredient in other combination medications like Percocet and acetaminophen with codeine.

A health concern for patients taking acetaminophen has become a concern because, in some cases, it can cause serious skin reactions.

The Statistics

Over the course of 40 years, there have been almost 100 cases of a serious skin reaction to acetaminophen. There have been 67 resulting hospitalizations and 12 deaths. This is a potentially serious, albeit rare, reaction.

The U.S. Food and Drug Administration (FDA) has stepped in and made new safety and label warning recommendations.

The Warning

U.S. Food and Drug Administration requires that a warning about this potentially serious adverse reaction be listed on the labels of all prescription drugs containing acetaminophen.

The FDA ruling takes into account both prescription drugs containing acetaminophen and plain OTC acetaminophen. The manufacturers of the common over-the-counter (OTC) drug will be requested to add a warning to their labels, as well.

Ibuprofen and naproxen are often used to treat pain and fever, as an alternative to acetaminophen. Interestingly, these common drugs already include the same skin reaction warning on their labels.

Stevens-Johnson Syndrome

The potential skin reaction is called Stevens-Johnson Syndrome (SJS). It is a rare condition but it can be lethal. The symptoms of SJS include:

  • Blisters
  • Rashes
  • Reddened skin
  • Detachment of the upper layer of skin or the epidermis

This serious adverse reaction can happen even after just one dose of acetaminophen.

Treatment of SJS

Patients who develop any rash or other skin condition while taking acetaminophen should stop taking the drug immediately and seek medical attention with their physician or in an emergency room. Even an occasional minor skin reaction warrants medical attention, according to the FDA ruling.

The treatment, in an intensive care unit, is supportive care. It includes:

  • Intravenous fluids for hydration
  • High calorie formula to enhance healing
  • Antibiotics to prevent a secondary infection or sepsis
  • Pain medication for patient comfort

The medical team includes burn, ophthalmology, infectious disease and dermatology specialists.

The Result

According to the SJS, there are 150,000 deaths in the U.S. every year due to adverse drug reactions. This statistic makes adverse drug reactions the 4th leading cause of death in the U.S. The reaction to acetaminophen plays a role in this statistic and must be taken seriously.

Acetaminophen is a common ingredient alone and in many other drugs. Many patients have used it over many years. This makes it difficult to get the attention of most people and have them take this potential threat seriously. It is important to note that this skin reaction to acetaminophen is rare.



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