Should the Drug Zofran Be Avoided During Pregnancy?

A provocative question and one for which this writer has no expertise to share with you. However,  Krystal Blake, of the Birth Injury Guide has studied the matter and has prepared the following guest article for today's post. As always with such matters, each person is cautioned to gather all the available facts and to make an informed decision that makes sense to her and her doctor.

Here's the article:

"What are the Potential Side Effects of Zofran? 

Zofran, also known as Ondansetron, is a prescription medication that is 
manufactured by the pharmaceutical company GlaxoSmithKline (GSK). Zofran1 
was originally developed to help mitigate the effects of chemotherapy and 
radiation that cancer patients often suffer from. This drug can effectively block 
the actions of the body that trigger nausea and vomiting. In addition to being 
used to treat nausea in cancer patients, it was also used and prescribed to treat 
nausea in patients post-operatively. 

Since its development, however, Zofran has also been used “off-label” to treat 
women for morning sickness. Typically prescribed during a pregnant woman’s 
first trimester, it has been given to millions of women across the country for 
years. 

What Does “Off-Label” Mean? 

The term off-label drug use2 has several meanings. It may involve prescribing a 
currently available and marketed drug for a symptom or disease that the Federal 
Drug Administration (FDA) has not approved, or it may involve prescribing a 
marketed medication to a patient population, dosage, or dosage form (e.g., 
intravenously, orally, topically, etc.) that does not have FDA approval. 
Zofran has been prescribed off-label to a patient population that the FDA has not 
approved use for as there are not sufficient studies or tests that have been 
conducted in the respective population to show that it is safe for this particular 
use.

How Does Zofran (Ondansetron) Work? 

Zofran, a powerful anti-nausea and vomiting drug, belongs to a class known as 
the 5-hydroxytryptamine receptor 3 antagonists that block the effects of 
serotonin.3 More commonly referred to as 5-HT3 antagonists or setrons, this class 
of drugs acts as receptor antagonists at a subtype of serotonin receptor found in 
the vagus nerve and other areas of the brain. These receptor antagonists are 
extremely effective in treating nausea and vomiting in patients undergoing 
chemotherapy, radiation, or post-operatively to help with the side effects of 
anesthesia.

Drugs used for chemotherapy often create serotonin in the gut which causes 
nausea and vomiting. With the help of these serotonin antagonists, the body is 
able suppress nausea and vomiting by preventing serotonin from activating and 
sensitizing the gut.4 

The FDA and Zofran

Zofran first entered the U.S. market in 1991 and it was FDA approved for the 
uses previously mentioned. In 2011, the FDA administered a warning about the 
drug indicating that there had been links between Zofran use and QT interval 
prolongation, or effects on the electrical activity of the heart.5 Shortly after, there 
were also warnings regarding the increased risk of birth defects developing in 
children whose mothers had taken Zofran during pregnancy. Among the most 
universally known birth defects associated with the drug are cleft lip and cleft 
palate, in addition to heart defects, including Atrial Septal Defect (ASD).6

There have been a number of studies regarding the drug’s potential effect on 
pregnant women, but additional studies are warranted. The CDC has issued a 
warning of the possible connection between Zofran use and birth defects, and 
the FDA has continued to condone prescribing drugs off-label. However, many 
people believe that more studies are needed in order to obtain a clear answer on 
the risks associated with taking the drug during pregnancy.7"

For further information check out their link at: 

http://www.birthinjuryguide.org/birth-injury/causes/medication/zofran/

Footnotes:
1 http://www.drugs.com/zofran.html
2 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/
3 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3470505/

4  Kamm MA (March 2002). "Review article: the complexity of drug development for irritable bowel syndrome". Alimentary Pharmacology & Therapeutics 

5 http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm

6 http://www.heart.org/HEARTORG/Conditions/CongenitalHeartDefects/AboutCongenitalHeartDefects/Atrial-Septal-Defect-ASD_UCM_307021_Article.jsp

7 http://www.birthinjuryguide.org/birth-injury/causes/medication/zofran/zofran-research-shows-birth-defect-links/

Enjoying A Senior Lifestyle

From childhood to your senior years, you'll transition through numerous lifestyles. When it's time to enjoy a senior living lifestyle, you'll be able to apply many of the life lessons you've learned along the way to the adventures that await. Over the years, you may have compiled a mental list of things you want to do now that you have the extra time and new-found freedom. If you've been too busy to give much thought to how you want to enjoy your retirement years, you can get some amazing ideas and inspiration from sources such as Retirement Living Magazine and friends who are already actively enjoying their retirement years.

Local Activities

When your schedule was full with work and family obligations, you might not have had the time to participate in nearby activities and local places of interest. Now that you're retired, do some exploring around your area to discover interesting attractions.

Get reacquainted with your home

Your retirement lifestyle can make leisurely mornings a reality rather than a dream. An afternoon outdoors with a good book and a cold drink is an activity you can enjoy now. There's an abundance of great movies just waiting for you to watch. Invite some friends over for a marathon movie night. Without a work schedule, you don't have to be concerned with getting to bed on time so you can be alert for work the nest day.

Travel

In addition to exploring activities near your home, you may want to travel to distant destinations that you've dreamed of visiting. If you're undecided about where to go, take some time to read about the many travel packages and destinations designed especially for seniors. Look at the variety of travel modes you have available to you. Don't be afraid to step out of your comfort zone by taking a cruise, experiencing RV travel or flying to your destination. If you're uncomfortable traveling alone, you can arrange a trip with a tour group.

There's a lot to look forward to in your retirement years. This is a great time to get reacquainted with old friends and make new friends. Finding a balance between a relaxed lifestyle that includes lazy days and no definite schedule to abide by and the freedom to explore new places and experience new adventures is the key to happy, fulfilling and rewarding retirement years. 

Why RN's Become Nurse Practitioners

Solidify a Job in the Medical Field with a Nurse Practitioner Degree

If you are a registered nurse, but want to treat the patients and diagnose illnesses, you will want to take the next step and become a nurse practitioner. Becoming a nurse practitioner allows you to become closer to people and really help them feel better in all facets of their life. It gives you the benefits of being similar to a doctor, without the extra educational costs.

Rising Health Needs

More people need the care of a medical professional due to the growing number of obesity and cancer cases. The need for nurse practitioners is growing, which makes it a real solid field to go into. Physicians are becoming overwhelmed with the increased number of patients, so nurse practitioners are used to visit with the patients first. With the assistance of practitioners, the wait times for patients are reduced, which makes everyone happy.

Affordable Care

The cost to become a doctor is great, so the cost is deflected to their patients. Many people are having trouble paying for medical care because of this, and have selected walk-in clinics and other clinics that are run by nurses. In fact, there are over 250 clinics throughout the country, which offer affordable care and vaccinations. Nurse practitioners fill the need for more affordable care.

In addition to providing cheaper care for the patient, they make less than physicians do. It is because of this fact that clinics can remain open. By switching over to fewer physicians and more nurse practitioners, clinics lower their overhead costs. When clinics can stay open, people can get the help they need.

Become an Advocate

Nurse practitioners have the great ability to get to know their patients well. You can treat a person from childhood to senior years. You are the go between them and the physician, which makes you their advocate. You have the time to listen to their stories and help them get the help they need. Over 60-percent of people, receive their preventative care from a nurse practitioner rather than meeting with the physician directly.

Depending on where you work, your employer may help with the cost of a nurse practitioner degree. The work you can do will continue to grow as specialization is possible.

Robert Tell, Author

Dementia Diary, A Caregiver's Journal

Diabetes & Food Allergies--Two Interesting Programs!

As part of our mission, we will continue to bring health related information to the readers of this blog.

Here are two health related sites we recently encountered:

1) Help show your support for diabetes awareness and claim your wristband:

Click:    Diabetes Awareness!

2) A magazine for living with food allergies:

Click:    Living Without

Full disclosure: We discovered these messages as we surfed the web and haven't had a chance yet to try them ourselves. So we can't recommend them based on personal experience. If you do check them out, please use your best analytic judgement in deciding whether or not to take advantage of these offers.

Why Caregivers Need Respite Care!

Every day, people who take care of their aging loved one’s face many challenges and difficulties. Being a caregiver is a demanding job, and no one person is strong enough or prepared enough to handle it alone. Because your health is important to you and for your loved one’s well-being, you should get good help when you need it. The essence of good respite care, like the care you can get at companies such as Synergy Home Care, is to give you the break you need to restore your energy, enhance your sense of balance and relieve stress. 

Because it can be challenging to take care of a senior loved one, you can choose from many respite care options available to give you the assistance you might need. This helps to restore your energy and allows you to be a responsible caregiver for your senior loved one. The principles of respite care are all the same, which is to ease the burden of caregiving with someone else and have some time for you. 

Respite care starts with the realization of your needs and your loved ones needs. Knowing your needs for frequency, type, skills and location of the respite care is important so that you get the proper respite. Consider what you need the most. Is it regular time off? Is it the need for help with transportation? Make a list of your daily activities, and write down the times and places you need assistance most. 

Your loved one’s needs, preferences and abilities are important as well. Does your loved one need assistance with walking, eating or taking medications? Is it socializing that your loved one needs most? Does he or she need physical or mental exercise? When you know the needs, you can find the right option for respite care. 

Adult respite day care centers are intended for elderly adults who can’t live independently or are isolated and lonely. The environment is cheerful, safe and supportive. Adult day centers have several planned activities to promote your loved one’s well-being. In most cases, there is a schedule for nutritious meals, and they do accommodate special diets. 

If you have a loved one who you take care of around the clock, respite care might be the perfect solution for you. 

Robert Tell, Author

Dementia Diary, A Caregiver's Journal

How Can Yoga Benefit Seniors?

What follows is a guest article by Carolina Sewald, staff writer for Drug Dangers. Hope you find it to be useful!  Robert Tell, Author and Host of The Caregiver Chronicles

Benefits of Yoga for Seniors

"Yoga has been known for its countless benefits for both mental and physical health for hundreds of years. This method of alternative medicine has been used by thousands of people to help alleviate stress, improve fitness and, in some cases, aid in treating chronic diseases such as depression or anxiety.

Depression is very common among seniors especially after moving into an assisted living community. They begin to feel lonely and lose sight of their happiness. With little activity in nursing facilities, seniors are seldom given the opportunity to interact with each other and socialize.

Facilities across the country have begun holding monthly yoga classes and have experienced great success in doing so. Not only do the residents have the opportunity to interact and be active, recent studies have shown that yoga can actually improve cognitive function aiding in memory for those with Alzheimer’s disease. 

A study group of 135 senior men and women were enrolled and participated in six months of yoga classes and after reported an increase in happiness, well-being, and flexibility. Flexibility is especially important for senior citizens as they often fall or injure themselves while bending over or reaching for something.

The necessary focus and concentration needed for poses and meditation can also help the seniors with remembering things in the short term. A teacher frequently asks her class, “What pose is this?” in order to work their memory throughout class and emphasizes the importance on constant engagement with all students.

Many overlook the benefits of yoga believing it only helps with physical health without understanding the mental benefits it can have. Establishing a practice in everyday life can improve overall health for anyone that decides to participate.

Authored by Carolina Sewald. Carolina is currently a student at UCF in Orlando, Florida and just recently became a part of the Drug Dangers team. She is the content writer and focuses mainly on medical news and information."

Sources:

http://www.healthcentral.com/alzheimers/c/62/43503/alzheimer-benefits?ic=2602

http://www.boston.com/lifestyle/articles/2008/09/30/breath_lives_memory/?page=2

Are the Critics of ObamaCare being fair?

I promised myself when I started this blog that I would avoid being overtly political in my posts. This is an exception.

What follows is my response to a physician friend, a very Conservative individual, who continuously bombards me with emails attacking the Affordable Health Care Act and anything having to do with Obama. I finally got fed up and replied. By the way, he and I may argue but we are always civil to each other and wish to remain friends.

"Dear_______

I read your comments about the Affordable Care Act and, no surprise, disagree with you completely. Here's a different point of view.

I believe the media is totally distorting the reality of a marvelous (if imperfect) plan that would work quite well if people would just give it a chance. I lived through the same kind of nonsense attacks on Medicare in 1965 when it went through it's growing pains, and Bush's Rx plan was a nightmare at first that could have been subject to the same scrutiny if the democrats wanted to use it for political purposes. So did the Massachusetts plan which now works well but was a horror in the rollout. Romney should be ashamed of himself for running away from the single most important thing he did as Governor.. 

The so-called insurance that some people are now losing isn't worth the paper it was written on and one of the best benefits of the ACA will be getting rid of those phony insurance plans. In many cases where someone says they lost their coverage it turns out they are actually eligible for better coverage at subsidized rates. And they will know this as soon as the bugs are out of the website. Yes, the website rollout sucks, but it's just a website, not the plan which is loaded with benefits the public and the ratings-chasing media do not yet understand.

By the way, I have much more sympathy for 50,000,000 Americans who were totally uncovered but can now have protection against health care bankruptcy than I do for the temporarily discomforted and relatively few true hardship cases these anecdotes keep dramatizing. 

As you know, I have studied health systems all over the world and, at one point in my career, I was considered a a bit of an expert on it. I have worked my entire professional life trying to help get a universal health care program in America and am heartbroken at the lies that are successfully confusing the media and the public.  

If they succeed in destroying this market based program, I believe the next step will be a huge movement for a real government run single payer system, and I will be in the street advocating for it. I don't have that many years left in which to see this dream realized.

Your friend,

Bob"

I would encourage a civil dialogue on the subject on this blog but will not approve (and may delete) comments that don't meet that standard. Feel free to disagree but, if you do, tell us what you would do instead (if it became your responsibility) to protect the 50,000,000 uninsured and underinsured fellow Americans. But don't tell me you don't care about them. If that's your opinion, please keep it to yourself.

Robert Tell, Author,