FDA and Cardiovascular Conditions: Approvals and Warnings; New MRSA Test; Benzocaine Hazard

By Mary Jane Dittmar



The National Volunteer Fire Council (NVFC) reminds us that May is Mental Health Month and that “firefighting can take stress to a whole new level.” Taking care of your mental health is as important as managing your physical health. Mental Health Month brings awareness of mental health challenges and solutions. It is also an opportunity to focus on your department’s mental and behavioral health outreach. The NVFC strongly encourages departments to adopt this and all of the B.E.S.T. practices to keep their members healthy and safe. Learn more at www.nvfc.org/health_safety.

Mental disorders are common in the United States and internationally. Recognizing the signs of mental illness is important. Feelings of sadness, anxiety, worry, or sleep problems are not uncommon. However, when these feelings get very intense; last for long periods of time; or begin to interfere with school, work, friendships, and other relationships; it may be a sign of a mental illness. Mental disorders are appearing more often in children as well. To learn more about mental health issues, visit these sites:
















The U.S. Food and Drug Administration (FDA) is charged with regulating the foods and beverages we ingest, the medicines we take, the over-the-counter drugs and products we use, and the therapeutic devices and protocols used to treat us when our health is impaired. Some recent actions taken by the FDA (the majority of them in May) show how these actions affect our everyday lives and quality and length of life in some cases. We will look at a few examples of actions taken by the FDA recently that could affect our health and well-being.

Photo by www.photos8.com










FDA Expands Approved Use for Carotid Stent

Patients at risk of stroke because of clogged neck arteries now will be able to be treated with the RX Acculink carotid stent. Previously, only those at high risk of complications if undergoing carotid endarterectomy–a surgical procedure in which the neck artery is cut open and the plaque is scraped out–qualified for this procedure.

Note: It is a good idea to have an ultrasound of your carotid arteries as part of your yearly checkup. Check with your doctor as to when this should begin; it depends on age and your health history. One day, my husband Joe came home and told me that he was speaking with a friend at the local drugstore and suddenly stopped speaking and lost his trend of thought. In the back of my mind, I thought it could be some type of stroke, but he seemed to be fine. When he went for his annual eye examination a few weeks later, the ophthalmologist became quite upset. He saw bleeding behind Joe’s eye and said it was imperative that we follow this up with a visit to a retina specialist. We did so and went to our cardiologist also, who recommended the ultrasound study of his carotid arteries. We were surprised to learn that he left carotid artery was totally blocked and that nothing could be done to open it, or a stroke might follow. Luckily, my husband’s body had provided an alternate route for blood flow to the eye and brain. As far as we know, his only symptom was that interrupted speech. We now do periodic studies of the other carotid artery so we can intervene if it becomes blocked beyond a certain percentage.

With the RX Acculink, physicians insert a catheter into the groin and thread it up to the affected neck artery. Physicians then place a small mesh tube, called a stent, into the artery to keep the artery open.

The FDA based its approval on a 10-year study of 2,502 patients at 119 clinical sites in the United States and Canada. Patients were treated and followed for at least one year. The National Institutes of Health helped to fund the study, which found that patients treated with RX Acculink had a similar combined rate of death, stroke, and heart attack (myocardial infarction) as those who underwent surgery.

An outside expert advisory panel convened by the FDA on January 26, 2011, found the RX Acculink to be generally safe and effective for use in this new group of patients. The panel emphasized, however, that it was important to obtain additional long-term follow-up information and that the stent be used in conjunction with an embolic protection device to capture plaque and other debris that break away during the procedure, which potentially could cause a stroke.

The FDA based its approval on the condition that the manufacturer, Abbott Vascular, conduct a post-approval study, which follows new patients treated with RX Acculink for at least three years to confirm the results identified in the premarket study. The post-approval study will also evaluate how patients age 80 years and older respond to treatment, whether treatment success is affected by the physician’s experience with the product, and whether patients who show symptoms of having a clogged carotid artery experience a different outcome than those who don’t show any symptoms prior to treatment. The study is consistent with recommendations made by the expert advisory panel.
Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets

Bristol-Myers Squibb is voluntarily recalling Lot Number 9H49374A of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets, distributed to pharmacies. The lot has an expiration date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected. Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots, which could lead to heart attack or stroke; if there is too much active ingredient, there is an increased risk of bleeding. If you or a member of your family is taking this medication, do not interrupt therapy, but immediately check with your pharmacist to see if it has tablets from the affected lot. If so, consult the physician for appropriate medical advice. Bristol-Myers Squibb has notified the FDA and will issue recall communications to all physicians and other customers involved. Report any adverse reactions to the FDA’s MedWatch Program by fax at (1-800) FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or on the MedWatch Web site at www.fda.gov.  The complete press release is at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm253615.htm

Test Can Diagnose MRSA in About Five Hours

The FDA has cleared KeyPath MRSA/MSSA Blood Culture Test (manufactured by MicroPhage Inc. of Longmont, Colorado), the first test for Staphylococcus aureus (S. aureus) infections. The test can determine within about five hours after any bacterial growth is first detected in the sample if the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA). All that is needed is blood culture equipment; no specific instruments are necessary.

There are many different types of Staphylococci bacteria, which cause skin infections, pneumonia, and food and blood infections (blood poisoning). Some S. aureus infections are treated easily with antibiotics;  others, like MRSA (which has been a problem in many fire departments), are resistant to commonly prescribed antibiotics such as penicillin and amoxicillin.

“Clearing this test gives health care professionals a test that can confirm S. aureus and then identify whether the bacteria is MRSA or MSSA,” says Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health. “This not only saves time in diagnosing potentially life-threatening infections but also allows health care professionals to optimize treatment and start appropriate contact precautions to prevent the spread of the organism.”

MRSA infections can occur anywhere, but those occurring in health care settings are usually more severe and potentially life-threatening since hospital patients may have weakened immune systems and frequently undergo procedures such as surgery, which allows bacteria to easily spread directly into the body.

The FDA clearance was based on a clinical study of 1,116 blood samples evaluated at four major U.S. hospital centers. Within the organisms determined to be S. aureus, the MRSA determination was 98.9 percent accurate (178/180) and the MSSA determination was 99.4 percent accurate (153/154). Additional information is at www.cdc.gov/mrsa/definition/index.html.

Warning: Benzocaine Products

The FDA continues to receive reports of methemoglobinemia—a rare but serious condition—associated with benzocaine products. These products may be used as a spray during medical procedures to numb the mucous membranes of the mouth and throat and as a gel or a liquid sold over-the-counter to relieve pain from teething, canker sores, irritation of the mouth and gums, and other conditions. Brand names include Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands. Methemoglobinemia is a condition in which the amount of oxygen carried through the bloodstream greatly decreases. In the most severe cases, methemoglobinemia can result in death.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids. The condition occurred mainly in children age two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear from within minutes to hours of applying benzocaine and may occur after just one use or after additional uses. Signs and symptoms include pale, gray, or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; tiredness; and rapid heart rate.

The FDA recommends the following to avoid methemoglobinemia:

  • Call 911 immediately if you or someone you are caring for has any of the symptoms listed above after receiving benzocaine.
  • Do not use benzocaine products on children under two years of age, except under the advice and supervision of a health care professional.
  • Adults who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations on the product label.
  • Store benzocaine products out of reach of children.
  • Talk to your health care professional about using benzocaine.

Additional information is at http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm253470.htm

Medication Watch:

Recall: Coumadin (warfarin sodium) Crystalline 5 mg Tablets

The U.S. Food and Drug Administration (FDA) has advised that Bristol-Myers Squibb has initiated a recall of one lot of 1,000-count bottles of the drug because the tablets may have a higher than expected potency.
The lot number affected in the United States is 9H49374A; the expiration date is September 30, 2012. A decrease of active ingredient may increase the risk of clots, which could lead to heart attack or stroke. Too much active ingredient could increase the risk of bleeding. Coumadin is prescribed to treat or prevent blood clots.

If you or someone you know has been prescribed 5 mg tablets, do not stop taking the medication. Consult your pharmacist to see if the tablets you have were part of the affected lot. If so, consult your physician for appropriate medical advice.

Mary Jane Dittmar is senior associate editor of Fire Engineering and conference manager of FDIC. Before joining the magazine in January 1991, she served as editor of a trade magazine in the health/nutrition market and held various positions in the educational and medical advertising fields. She has a bachelor’s degree in English/journalism and a master’s degree in communication arts.


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