Archive for the ‘New Drugs’ Category

Meningitis & Your Baby: Three Things To Think About

Tuesday, April 26th, 2011

A quick story.  I remember opening the piece of mail. It was a quick note from a school official informing the student population that there was a suspected incidence of meningitis at another local university. The long and short of it was that if, as a residential student, I didnt want to move back home with my parents, I wanted to continue to live on campus, I would need to sign a waiver or be vaccinated.

Too many years have gone by, and  I can no longer remember what I chose, but the thought of meningitis made me think very carefully about whether I wanted to be vaccinated. At the time I didn’t know much about meningitis, but with the stern warning I received in the form of that letter, I researched and learned that the effects of bacterial meningitis (commonly caused by Neisseria meningitides) can be devastating. My choice notwithstanding, the choice of “to vaccinate or not” has recently been extended to that parents of infants and toddlers.

1. The signs of meningitis

The classic symptoms of meningitis are a high fever, headache and stiff neck. Detection of these symptoms, particularly headache and stiff neck are certainly difficult to detect in infants and toddlers. According to the Centers for Disease Control and Prevention, infants with meningitis may appear slow or inactive, have vomiting, be irritable, or be feeding poorly. Seizures are also a possibility.

2. An Ounce of Prevention: A vaccine is available

I was fortunate; I had the choice. I was a young adult, and I had access to a vaccine. Until recently, however, parents could not make a similar choice for their small children. The Food and Drug Administration (FDA) has recently approved a vaccine to prevent meningitis in babies and toddlers. Specifically, the FDA has approved the vaccine Menactra for usage in babies and toddlers. Menactra has been frequently used to vaccinate non-toddlers and non-elderly (ages 2 to 55). For now, the FDA has approved the usage of Menactra in babies as young as 9 months.

3. Is it safe to give to your child?

The FDA has ushered Menactra into the great debate of “to vaccinate or not to vaccinate.” I’ve read the literature and opinions of others on the topic. Each position has its passionate advocates. Putting the debate aside, the potential harm created by meningitis is well documented. Even though rates of meningitis are low in the United States, infants and toddlers are particularly vulnerable.  Meningitis can develop rapidly; in a matter of hours or days.  Even with proper care, the FDA says up to 15% of people who develop meningitis die from the infection. Of the people that contract meningitis, one in four will suffer complications such as brain damage or hearing loss. A scary number for any parent to consider. So, no matter what side of the debate you stand on, at least you now have a choice for your baby.

It doesn’t say “leave a response” down below for nothing. Feel free to let us know…

QUESTION:  What choice will you make?  Is vaccinating with Menactra a choice you will make?

 

Follow-up Blog: Important questions and answers on Pradaxa

Monday, January 10th, 2011

Some months ago, we published a blog to announce what we thought was important medical news about a new product called Pradaxa. That blog, entitled A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?, was widely viewed by many readers since October, 2010. Following our posting, a number of those readers have sent us questions about this new drug. To better serve our readers, we have invited Dr. Steven M. Davis to be our guest blogger on Pradaxa, and to answer some of these important questions.

Dr. Davis is the Associate Professor of Pharmacy at the Campbell University College of Pharmacy and Health Sciences in Buies Creek, NC. He is also the Clinical Coordinator for Pharmacy Services at Wake Forest University Baptist Medical Center in Winston Salem, NC. Dr. Davis has a PharmD with a specialty certification in geriatric pharmacology.

Below are the most frequently asked reader questions:

  1. How does Pradaxa differ chemically to Coumadin (Warfarin)?
  2. Do things with high Vitamin K (like spinach, lettuces, and broccoli) interfere with Pradaxa?
  3. If one were to start Pradaxa, how long would it take the blood to thin? If one were already taking Coumadin (Warfarin), what is the recommended method of switching to Pradaxa?
  4. How long would it take to reverse the effects of Pradaxa? I have been told Coumadin (Warfarin) stays in the body and before any surgery a patient has to wait 5 days.
  5. Why doesn’t the blood coagulation need monitoring if Pradaxa thins out the blood? Why wouldn’t the blood protime (PT) need monitoring with Pradaxa?
  6. How would someone adjust Pradaxa to keep the protime (PT) at a desired level?
  7. Are there any restrictions to other medications such as Aspirin?

Dr. Davis’ responses are listed below:

Question 1: Pradaxa (Darbigatran) is a direct thrombin inhibitor.  Thrombin is one of many clotting factors in the body necessary for coagulating blood.  Coumadin (Warfarin) works by a completely different mechanism. Coumadin/Wafarin prevents the activation of 4 clotting factors that depend on Vitamin K .

Question 2: Since Pradaxa works by directly inhibiting the clotting factor thrombin, the amount of vitamin K in the diet does not matter.

Question 3: When switching from Coumadin to Pradaxa, a physician will usually wait for a patient’s INR to drop below 2 before starting Pradaxa.  In most patients taking Pradaxa, blood will be appropriately thinned 2 to 3 days after starting the medication.

Question 4: Pradaxa is still a blood thinner and care must be used before surgery.  Pradaxa has a shorter life in the body (that is why it is dosed twice daily) and it is cleared from the body quicker than Coumadin (Warfarin).  It is recommended that a patient discontinue Pradaxa 1-2 days before surgery if they have normal kidney function and 3-5 days if they have impaired kidney function.  Of course you would NEVER stop this medication without consulting your physician first.

Question 5: Prothrombin time (PT) and INR measure the ability of Coumadin (Warfarin) to prevent the activation of the Vitamin K dependant clotting factors.  Again, since Pradaxa does not affect these factors, the prothrombin time does not change and, therefore, does not need to be monitored.

Question 6: The biggest advantage to Pradaxa is that there are fewer drug interactions, less food/drug interactions (Vit K containing foods), and thus no need to monitor prothrombin time or INR.

Question 7: Combining Pradaxa with aspirin will increase a patient’s risk of bleeding.  Both medications are used together frequently but ONLY under the direction of a physician.

Dr. Davis offers the following advice to patients considering taking or taking the drug Pradaxa.

This is a new medication and as with all new medications, it has not been used in a large population of patients yet.  New side effects and drug interactions may be discovered as this drug is used more frequently.  The Food and Drug Administration (FDA) monitors these reports and will issue statements as necessary.

From Brian Nash: I want to take this opportunity to thank Dr. Steven Davis for providing us with this information for our readers.

To our readers: Please keep in mind that we, at Nash & Associates, are not physicians. While Dr. Davis was so kind to provide the information he did regarding Pradaxa, this is not the usual approach we would take to our blog postings. From time to time we try to make you aware of important and/or interesting medical news. However, if you have questions about Pradaxa, we strongly urge you to speak with your personal physician.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Who’s Hawking Rx Drugs? Is It Really an Effective Medication or Just Effective Marketing?

Thursday, October 28th, 2010

We have all seen the non-stop drug ads on TV – a pill or injection that will cure whatever it is that ails us. Public advertising, however, is just one way that pharmaceutical companies get their drugs into the market place. Behind the scenes, there is a full-blown marketing campaign that the public never sees in which drug companies hire doctors (tens of thousands of doctors) to spread the word on their drugs, primarily by giving talks to other doctors.  An ongoing investigation by ProPublica reveals that some of these doctors have significant disciplinary actions in their past:

A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.  More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

There is no doubt that the pharmaceutical industry (sometimes referred to as Big Pharma) is a huge industry.  According to IMS Health,a healthcare information and consulting company, prescription drugs generate $300 billion in sales in the United States alone.  Therefore, the pressure on drug companies to market their products is immense. For the doctors out there, doing free-lance work for drug companies can be a very lucrative side-business, with some physicians earning as much as $1,500 to $2,000 for giving a single talk to a group of doctors. While there is nothing wrong with marketing a legal product, the public must be assured that the marketing is honest and that the drugs in question are being prescribed because they are effective drugs, not simply because the drug companies have an effective marketing campaign.

“Without question the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

Big Pharma appears to be turning a relatively blind eye to the situation. As part of its investigation, ProPublica compiled a database of physicians who work for the drug companies, and then cross-checked these doctors’ credentials and state disciplinary records.  The drug companies themselves could have taken this approach in vetting their doctors, but most do not bother to do so. Most companies “rely on self-reporting and checks of federal databases.”  However, it is the state disciplinary records that typically contain the relevant data on doctors who have been disciplined (and even state authorities do not always post such infractions on their websites). Lisa Bero, a pharmacy professor at University of California, San Francisco, questions the way that Big Pharma checks on its doctors:

Did they not do background checks on these people?  Why did they pick them? If they did things in their background that are questionable, what about the information they’re giving to me now?

In addition to disciplinary actions, ProPublica also raises questions as to these doctors’ credentials, e.g. medical research, academic appointments and professional society involvement, that would make them especially qualified to speak on medical conditions and ways to treat them. The investigation highlights a Las Vegas endocrinologist who has earned over $300,000 from Big Pharma. However, ProPublica contends that it was unable to locate any credentials on this doctor other than his schooling and some 20-year-old research articles. Furthermore, an online brochure from a recent presentation given by this doctor indicated that he was the chief of endocrinology at a local hospital, but “an official there said he hasn’t held that title since 2008.” Such stories only add to the serious questions as to how Big Pharma is selecting its doctors.

Certainly, a lot of good can come from honest marketing of effective new drugs. Especially in out-of-the way places, a talk by a knowledgeable physician can be a great source of information on new treatments available for a certain disease. If a new drug is truly effective, then by all means the word needs to get out on that drug because such drugs allow us to live longer and to live more comfortably with what were once debilitating diseases.  However, the public must demand honest assessment of these drugs. When drug companies allow unscrupulous doctors to hawk their wares, it raises legitimate suspicion as to whether these drugs are so popular because they are truly effective or simply because they had a good marketing blitz.

If you are curious about a specific doctor, ProPublica has a searchable database of doctors who do work for drug companies. Also, ProPublica has published several follow-up and/or related articles which can be found here.

A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?

Friday, October 22nd, 2010

This week’s press release by the US division of the German based Boehringer Ingelheim pharmaceutical company is certainly a breakthrough for patients. The company announced the FDA approval of their drug Pradaxa (dabigatran etexilate). This is the first new oral anticoagulation drug approved in the US in more than 50 years.The drug was approved for stroke and systemic embolism prevention in people who have atrial fibrillation not caused by a failing/defective heart valve.

The press release touts impressive results. National studies have shown when Pradaxa 150mg was taken twice daily, there was a 35% reduction in stroke and embolism when compared with the traditional drug known to most as Coumadin (Warfarin). In addition, at the same dosing level both types of stroke (embolic/clot and hemorrhagic/bleeding) were greatly reduced when compared to Coumadin. More good news for patients taking the drug…

  • Very few drug interactions,
  • No more dietary restrictions, and
  • No more routine blood testing and dosing changes as required when taking Coumadin.

WHAT IS ATRIAL FIBRILLATION AND WHY DO YOU NEED TO TAKE BLOOD THINNING DRUGS?

Atrial fibrillation is a heart rhythm disorder caused by a malfunctioning electrical conduction system within the heart – see video.  It is usually identified by an irregular rapid heart rate that begins in the upper heart.The smaller 2 upper heart chambers, known as the atria, begin to contract quickly and in an irregular fashion. As electrical signals leave the atria and enter the 2 lower heart chambers known as the ventricles, they too begin to contract quickly and in an irregular fashion.  This irregular and rapid heart rate is unable to pump the blood through the heart and out to the body in a strong, efficient manner. Thus blood can pool in the heart and the lower extremities allowing clots to form. These clots dislodge and travel to the heart, lungs, and brain leading to a stroke. Therefore it is important to prevent the clots from forming by correcting the abnormal heart rhythm,  and by lowering the blood’s ability to form dangerous clots.

The press release noted an estimated 2.3 million Americans have atrial fibrillation and the number is expected to increase to 5.6 million by 2050. A large US-based managed care organization used their data to show 95% of all persons with atrial fibrillation have no heart valve problems. Atrial fibrillation increased the risk of stroke 5 times, and is an underlying condition in 15% of all US strokes. Atrial fibrillation related strokes are twice as likely to be fatal or severely disabling when compared to strokes from other causes.

MedicineNet.com today reported recent studies by the New England Journal of Medicine and the American Heart Association found Pradaxa was also more effective in preventing clots in patients experiencing acute coronary syndrome. Sweden reports the drug can be safely used in conjunction with Plavix and Aspirin drug therapies.

WHAT ARE THE DOWNSIDES?

With the good news, comes the drug’s downside. The company is forthcoming in reporting Pradaxa when administered in 150mg doses results in a higher rate of gastrointestinal bleeding related complications when compared to Coumadin. This dose was reported to also cause an increase in adverse GI reactions such as dyspepsia, abdominal and gastric pain, GERD, esophagitis, gastritis, and ulcer. Importantly, in patients older than 75 years of age, the risk of bleeding complications may be greater than Coumadin. Also noteworthy is the finding that the risk of myocardial infarction was greater in studies with patients taking the 150mg dose than those taking Coumadin.

The company warns patients taking other blood thinners, non-steroidal anti-inflammatory medicines, St. John’s Wort, and any drug that can cause abnormal bleeding reactions need to be avoided. Over the counter medications are included in this warning. The company’s public package leaflet notes the drug will interact with Amiodarone and Verapamil and Pradaxa dosing will need to be reduced. The drug may also affect the liver but not more then Coumadin. It is contraindicated in patients who are in kidney failure, liver failure, and pregnancy. Some report a Quinidine interaction.

The FDA has approved dosing in capsule forms of 75mg and 150mg twice a day. Those persons taking larger doses of 150mg need to be fully informed of the above possible complications before switching from Coumadin to an easier life with Pradaxa.

EASIER TO LIVE WITH, BUT WHAT WILL IT COST?

It will take 3 to 6 months before distribution begins and pricing is not known. As with any new drug introduced in the US, speculation is the cost will be just short of prohibitive. Canada Pharmacies online sell Pradaxa 60 capsules both 75mg and 150mg doses at approximately $350.00 each. Generic Coumadin 100 pills at variable doses sell for approximately $34.00 to $50.00. The high drug price for US patients may offset the life style improvements for many who pay out of pocket for drugs. It is not known if prescription drug plans will approve partial or full payment for the drug.

It is generally reported that Coumadin is not a popular drug. Consumers and physicians alike resound with the same low opinion of the drug.  It is a difficult drug for physicians to manage, and it has a great impact on quality of life for patients. If Pradaxa continues to show its improved lifestyle value with no hidden serious side effects, patients will be the winners. Hopefully over time competitors will surface and prices will be driven into an affordable range for the growing US atrial fibrillation patient population.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Related Post:

Follow-Up Blog: Important Questions and Answers on Pradaxa