The recall does not apply to children’s Tylenol meltaways or junior strength Tylenol meltaways.

McNeil has established a consumer call center at 800-962-5357 for parents or caregivers with questions.
Acetaminophen (Acetaminophen is an active ingredient in Tylenol) and Liver Injury, click here for an FDA consumer report.

Partial Product Recall List:
Children’s Tylenol Plus Cold MS Suspension 4 oz. Grape
Children’s Tylenol Suspension 4oz. Grape
Children’s Tylenol Suspension 4oz. Bubble Gum
Children’s Tylenol Suspension 4oz. Strawberry
Infant’s Tylenol Grape Suspension Drops 1/4oz.
Infant’s Tylenol Suspension 1/2oz. Cherry
Children’s Dye Free Suspension 4oz. Cherry
Children’s Tylenol Suspension 4oz. Cherry
Children’s Tylenol Plus Cough & Runny Nose 4oz. Cherry

For a complete listing of recalled products, which includes the lot number’s visit Tylenol’s page, here.

Help for High Blood Pressure

Enter the Polypill.  Researchers want to create a pill a 3 in one that can reduce the risk of heart attack, stroke and high blood pressure in one.  article here
Truth is it has been created or should I say they have been. When we eat whole foods, contained therein is a synergistic blend of vitamins, proteins, amino acids, flavonoids, solar and lunar energy and maybe even (hopefully) love from the gardener. We cannot get this from a pill.

Run This Way

Instead of running from nature, run to nature. Nurture yourself with learning how to live in balance. It’s free. It’s the healthiest choice for yourself and the planet. Give it a try. Polypill? Try basking in the sun, or hugging a dear friend, cook yourself a meal with a big dose of love in it…you’ll be glad you did, for benefits no Polypill could ever provide.

At Continuum Wellness we offer homeopathic care and wellness coaching to promote wholeness, health and well-being.

The new Food and Drug Administration drug package insert: implications for patient safety and clinical care.

Watson KT, Barash PG.
Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut 06520-8051, USA.

The United States Food and Drug Administration (FDA) is the scientific, regulatory, and public health agency that regulates many products, including food products, drugs, medical devices, radiation emitting devices, and cosmetics for the federal government of the United States. The FDA’s mission is to assure that consumer products made and sold in the United States are safe, effective, and pure. The purpose of the package insert (also known as prescription drug product insert or professional labeling) is to provide detailed drug information compiled and distributed by the drug manufacturer, after FDA review and approval.

In 2006, the standard format for the package insert was changed in an attempt to make it more user-friendly and a more efficient resource tool for practitioners.

According to the Institute of Medicine, in-hospital adverse drug reactions occur at a rate of 400,000 per year and incur $3.5 billion of extra hospital expense. It is expected that the new package insert format will enhance rapid access to important pharmacologic information and improve patient safety by decreasing medication errors.

The Calistoga, Calif., couple seem to reflect a trend. With many Americans putting off routine doctor visits and self-medicating to save money, use of alternative treatments is on the rise — even though evidence is often lacking on their safety and effectiveness.

Climbing sales of herbal medicines have paralleled the tanking economy, according to an Associated Press review of recent data from market-watchers and retailers.

One prominent example: Austin, Texas-based Whole Foods Market Inc. says its stores nationwide have seen an increase in sales of nutritional supplements and herbal products in the past several weeks. That’s “noteworthy” given the retail industry’s financial slump, said Whole Foods spokesman Jeremiah C. McElwee.

While winter is usually a busy time for herbal medicine sales because it’s the season for colds and flu, “more people are value shopping” now because of the economy, McElwee said.

Cathy Birleffi says she’s among them.

“The doctors are so much higher (in cost), the insurance isn’t paying as much,” said the 61-year-old self-employed bookkeeper and notary. Her husband, a retired dispatcher, has high blood pressure and seizures. Recent changes in their health insurance coverage resulted in $1,300 in monthly premiums, double what they used to be.

Until they tried herbal alternatives, including valerian for insomnia, “every time I turned around, it was $50 here, $75 there” for prescriptions, Cathy Birleffi said.

Among data reflecting the trend:

For the three months that ended Dec. 28, nationwide retail sales of vitamins and supplements totaled nearly $639 million, up almost 10 percent from the same period in 2007. That includes a nearly 6 percent increase in sales of herbal supplements alone, according to Information Resources Inc., a Chicago-based market research firm. Its numbers do not include Wal-Mart or club stores.
Nationwide herbal and botanical supplement sales totaled $4.8 billion in 2007, when the recession began, up 4.3 percent over 2006. That was a marginally higher increase compared with the previous year, according to Jason Phillips of the Nutrition Business Journal, an industry-tracking publication. Sales of animal oil supplements — mostly fish oils — were up 29 percent from 2006. While that was a decline from the previous year, both categories continued to show strong growth in a faltering economy.
A government survey released in December said concerns about the cost of conventional medicine influenced Americans’ decisions to try alternative remedies. “Nonvitamin, nonmineral natural products,” including fish oil and herbal medicines, were the most commonly used alternatives, taken by almost 18 percent of Americans in 2007, the report said. Among those users, roughly a quarter said they delayed or didn’t get conventional medical care because of the cost.
Report co-author Richard Nahin of the National Institutes of Health’s National Center for Complementary and Alternative Medicine offered cautionary advice on the topic.

People taking herbal and other supplements should let their doctor know what they’re using, said Nahin, acting director of the center’s branch that oversees outside research the agency funds.

Copyright AP

(rest of the story)

Benefits of Homeopathy

One of the benefits of homeopathy is that the remedies work to arouse your vital force to help your body to heal itself. The care itself is less expensive comparatively, so are the medicines, known as “remedies.” The amount of time the remedy is taken is generally much shorter than allopathic medications, with homeopathy less is more. As the body resets itself and healing is taking place the remedy is not taken.

The homeopathic model doesn’t induce additional financial pressures on someone when their energy is best used to heal.

Eleven percent, including Remicade (infliximab), used to treat Crohn’s disease and rheumatoid arthritis, and Avastin (bevacizumab), used to treat cancer, have been issued a “black box” warning.

The findings, from Dutch scientists, are published in the Oct. 22/29 issue of the Journal of the American Medical Association.

“This suggests the need for more in-depth investigation before approval and highlights the importance of vigilance in post-marketing surveillance for adverse effects,” Dr. Phil B. Fontanarosa, the journal’s executive deputy editor, said during a a Tuesday teleconference on the themed issue.

“[Adverse effects] generally occurred in general disorders, like serious allergic reaction or cardiac arrest, administration site problems, infections and infestations,” said Fontanarosa. “A lot of these drugs act on the immune system, so infections are common complications of these products.”

“We’ve always known that because biologics were going to modulate the immune system, there would be this risk,” said Lisa Saubermann, associate director of clinical pharmacy services at the University of Rochester Medical Center.

The first biologic treatment, recombinant insulin, was approved in the United States in 1982. Since then, more than 250 biologics have flooded the pharmaceutical market, representing roughly one-quarter of all new drugs approved by U.S. and European Union authorities.

Although all drugs carry risks, biologics are in a special class, because they are derived from biological sources, including antibodies, enzymes and hormones.

Enbrel (etanercept), for instance, is a tumor necrosis factor, a protein made by the body’s immune system. The drug, used to treat various forms of arthritis as well as psoriasis, was also the recipient of a black box warning (for infections and central nervous system disorders).

The authors of this paper, from Utrecht University, reviewed 174 biologics approved in the United States and/or the European Union between January 1995 and June 2007.

Between January 1995 and June 2008, 82 safety-related regulatory actions were issued for 41 of the medications, or almost 24 percent of the total.

Of these 82 actions, 63 were advisory letters to health-care professionals in the United States and Europe, and 19 were black box warnings. None of the drugs were withdrawn from the market.

For information about dihydropyridine calcium channel blockers read here
About Cleviprex:(from Medical News)

Cleviprex is a novel, investigational drug rationally designed to meet the needs of the acute care practitioner for an intravenous hypertensive agent. It is the first third-generation dihydropyridine calcium channel blocker that acts rapidly and reliably, is vascular- and arterial-selective, and has an ultrashort half-life. Cleviprex recently completed Phase III clinical trials.

Approval was based on clinical studies involving 1,406 people. The most common side effects were headache, nausea and vomiting, the company said.

Abstract

Dihydropyridine calcium antagonists play an important role in the treatment of hypertension and angina pectoris. They lower blood pressure by a well-characterized mechanism of blocking L-type calcium channels in smooth muscle cells. Additionally, there is growing evidence that dihydropyridines also modulate endothelial functions by other mechanisms, since macrovascular endothelial cells do not express L-type calcium channels. A number of studies have demonstrated that dihydropyridine calcium antagonists enhance bioavailability of endothelial nitric oxide (NO). (more)

A Number of Marketed Dihydropyridine Calcium Channel Blockers Have Mineralocorticoid Receptor Antagonist Activity (abstract link)
…our data suggest that, in addition to their calcium channel blocking activity, a number of dihydropyridine calcium channel blockers also have mineralocorticoid receptor antagonist activity at high doses, a finding which may thus prove useful for the design of novel antihypertensive drugs in the future.

Pediatricians don’t consider it necessary for heart screenings for children prescribed stimulant drugs. The American Heart Association initially recommended heart screening for children taking stimulant drugs. The current position is it not mandatory, but considering the number of children who have sudden cardiac death it may be useful to at least have the heart screen performed. The AHA has released an update clarifying their position, here. Basically an ECG screening is not considered mandatory.
U.S. News reported on this topic here
Following is the statement: of the American Heart Association
May 16, 2008

This statement replaces the April 21 news release

Endorsed by the American Academy of Child and Adolescent Psychiatry, the American College of Cardiology, Children and Adults with Attention-Deficit/Hyperactivity Disorder, the National Initiative for Children’s Healthcare Quality and the Society for Developmental and Behavioral Pediatrics

The American Heart Association released on April 21, 2008 a statement about cardiovascular evaluation and monitoring of children receiving drugs for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). As a result of language in the news release and the statement as published, there have been conflicting interpretations of the recommendations regarding the use of an electrocardiogram (ECG) in assessing children with ADHD who may need treatment with medications. The purpose of this joint advisory of the American Academy of Pediatrics (AAP) and the American Heart Association (AHA) is to clarify the recommendations.

• The scientific statement included a review of data that show children with heart conditions have a higher incidence of ADHD.

• Because certain heart conditions in children may be difficult (even, in some cases, impossible) to detect, the AAP and AHA feel that it is prudent to carefully assess children for heart conditions who need to receive treatment with drugs for ADHD.

• Obtaining a patient and family health history and doing a physical exam focused on cardiovascular disease risk factors (Class I recommendations in the statement) are recommended by the AAP and AHA for assessing patients before treatment with drugs for ADHD.

• Acquiring an ECG is a Class IIa recommendation. This means that it is reasonable for a physician to consider obtaining an ECG as part of the evaluation of children being considered for stimulant drug therapy, but this should be at the physician’s judgment, and it is not mandatory to obtain one.

• Treatment of a patient with ADHD should not be withheld because an ECG is not done. The child’s physician is the best person to make the assessment about whether there is a need for an ECG.

• Medications that treat ADHD have not been shown to cause heart conditions nor have they been demonstrated to cause sudden cardiac death. However, some of these medications can increase or decrease heart rate and blood pressure. While these side effects are not usually considered dangerous, they should be monitored in children with heart conditions as the physician feels necessary.

The statement has been revised to clarify the language and to assure that the intent is clear to all readers. This is available at:
http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.107.189473

The correction notice is at:
http://circ.ahajournals.org/cgi/content/full/CIRCULATIONAHA.107.189473/DC1.

This clarification has been endorsed by the American Academy of Child and Adolescent Psychiatry, the American College of Cardiology, Children and Adults with Attention-Deficit/Hyperactivity Disorder, the National Initiative for Children’s Healthcare Quality and the Society for Developmental and Behavioral Pediatrics.

According to a recent study more than half of insured Americans regularly take prescription drugs for chronic health problems. In some cases an individual may take 18 or more drugs daily (here) Yes, some would call this progress. If people are not being healed, which means to make whole, what is happening here. Until the public demands the choice of qualified health practitioners this is not going to get better. Are you aware that all of these drugs are seeping into the drinking water? Every living creature needs clean water. How will this cycle back onto the public. Our food supply also comes from this tainted water.

The first step to improving your health is to know that it can happen. No one is meant to live captive of pill after pill. Why is it important to know you can improve your health? You must have the awareness that it is a choice. The actions you take lead to a result. It takes motivation and daily choices that lead to the goal. All of the information that is available will not help unless you begin to use the information.

Second, stop looking for a quick fix. Seek to heal the cause of the problem. If you are stressed out, learn how to relax and practice. If you are addicted to salt, learn how to season your food. If you are angry, bitter or sad learn how to find joy and peace.

Explore. Seek out sound information. Is it easy? You decide. If it is worth it to you start now. Find a buddy. Pray. Work with a qualified practitioner. And know that it is possible. Start now, begin the process of healing your life.

Children with ADHD should get heart tests before treatment with stimulant drugs

Statement highlights:
• The side effects of stimulant drugs, like those used to treat ADHD are usually insignificant, but are important to monitor for children with ADHD and certain heart conditions.
• Children diagnosed with ADHD should receive an electrocardiogram (ECG) to rule out heart abnormalities before beginning treatment with stimulant drugs.
• Children currently taking stimulant drugs who did not have an ECG prior to treatment should get an ECG.

View the statement here

DALLAS, April 21 – Children with attention deficit hyperactivity disorder (ADHD) should get careful cardiac evaluation and monitoring – including an electrocardiogram (ECG) – before starting treatment with stimulant drugs, a new American Heart Association statement recommends.

The scientific statement on Cardiovascular Monitoring of Children and Adolescents with Heart Disease Receiving Stimulant Drugs is published online in Circulation: Journal of the American Heart Association.

In 1999, concerns over potential cardiovascular effects of psychotropic drugs, especially tricyclic antidepressants, but including stimulants, prompted an American Heart Association Scientific Statement: Cardiovascular Monitoring of Children and Adolescents Receiving Psychotropic Drugs. However, no specific cardiovascular monitoring was recommended for the use of stimulant medications. Warnings from the U. S. Food and Drug Administration (FDA) about stimulant medications and public concern for the safety of using them have prompted the current statement.

Studies have shown that stimulant medications like those used to treat ADHD can increase heart rate and blood pressure. These side effects are insignificant for most children with ADHD; however, they’re an important consideration for children who have a heart condition. Certain heart conditions increase the risk for sudden cardiac death (SCD), which occurs when the heart rhythm becomes erratic and doesn’t pump blood through the body.

Doctors usually use a physical exam and the patient and family history to detect the risk for or presence of health problems before beginning new treatments, including prescribing medication. But some of the cardiac conditions associated with SCD may not be noticed in a routine physical exam. Many of these conditions are subtle and do not result in symptoms or have symptoms that are vague such as palpitations, fainting or chest pain.

That’s why the statement writing group recommends adding an ECG to pre-treatment evaluations for children with ADHD. An ECG measures the heart’s electrical activity and can often identify heart rhythm abnormalities such as those that can lead to sudden cardiac death.

“After ADHD is diagnosed, but before therapy with a stimulant or other medication is begun, we suggest that an ECG be added to the pre-treatment evaluation to increase the likelihood of identifying cardiac conditions that may place the child at risk for sudden death,” said Victoria L. Vetter, M.D., head of the statement writing committee and Professor of Pediatrics at the University of Pennsylvania School of Medicine in Philadelphia.

Vetter also said doctors should evaluate children and adolescents already taking these medications if they were not evaluated when they started the treatment.

If heart problems are suspected after the evaluation, children should be referred to a pediatric cardiologist. Once stimulant treatment begins, children should have their heart health monitored periodically, with a blood pressure check within one to three months, then again at routine follow-ups every six to 12 months.

“Children can have undiagnosed heart conditions without showing symptoms,” Vetter said. “Furthermore, a child’s body changes constantly, with some conditions not appearing until adolescence.”

If the initial ECG was taken before age 12 years, it may be useful to do a repeat ECG after the child is over age 12 years, the statement says.

Widespread use of ECGs to detect heart abnormalities, including screenings for competitive athletes, is not routinely recommended by the American Heart Association. However, the writing group found using ECG screening in this specific population of children prescribed ADHD medication is medically indicated and reasonably priced. That said, however, lack of an ECG shouldn’t mean that kids who need ADHD treatment can’t get it.

“While we feel that an ECG is reasonable and helpful as a tool to identify children with cardiac conditions that can lead to SCD, if, in the view of their physician, a child requires immediate treatment with stimulant medications, this recommendation is not meant to keep them from getting that treatment,” said Vetter, who added that some children may not have access to a pediatric cardiologist who can evaluate an ECG or perform a cardiology consultation.

In 2003, an estimated 2.5 million children took medication for ADHD. Surveys indicate that ADHD affects an estimated 4 percent to 12 percent of all school-aged children in the United States, and it appears more common in children with heart conditions. Studies report that, depending on the specific cardiac condition, 33 percent to 42 percent of pediatric cardiac patients have ADHD, Vetter said. The number of undiagnosed children with heart conditions is unknown as routine heart screening is not performed, but Vetter said that a recent pilot study she presented at the American Heart Association’s 2007 Scientific Session indicated that up to 2 percent of healthy school aged children had potentially serious undiagnosed cardiac conditions identified by an ECG.

Data from the FDA showed that between 1999 and 2004, 19 children taking ADHD medications died suddenly and 26 children experienced cardiovascular events such as strokes, cardiac arrests and heart palpitations. Since February 2007, the FDA has required all manufacturers of drug products approved for ADHD treatment to develop Medication Guidelines to alert patients to possible cardiovascular risks.

Future studies are necessary to assess the true risk of SCD in association with stimulant drugs in children and adolescents with and without heart disease, Vetter said. However, studying SCD associated with drugs is difficult because the government’s reporting system is voluntary, which means local data on these types of deaths isn’t always reported nationally.

A registry of SCD events is necessary for further investigating this issue, the writing committee said. Such a registry would allow for a more accurate understanding of SCD, including the true incidence of it and the potential effectiveness of universal ECG testing and pre-participation screening questionnaires.

The statement writing committee said its recommendations are not intended to limit the appropriate use of stimulants in children with ADHD.

“Our intention is to provide the physician with some tools to help identify heart conditions in children with ADHD, and help them make decisions about the use of stimulant medications and the follow-up of children who take them,” Vetter said. “The goal is to allow treatment of ADHD, while attempting to lower the cardiac risk of these products in susceptible children.”

The writing committee also includes: Josephine Elia, M.D.; Christopher Erickson, M.D.; Stuart Berger, M.D.; Nathan Blum, M.D.; Karen Uzark, R.N., Ph.D.; and Catherine L. Webb, M.D.

###

NR08-1058 (CIRC/Vetter)

The American Heart Association/American Stroke Association receives funding primarily from individuals. In addition, foundations and corporations – including pharmaceutical, device manufacturers and other companies – make donations and fund specific American Heart Association/American Stroke Association programs and events. Revenues from pharmaceutical and device corporations are disclosed at www.americanheart.org.

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