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Once-a-day heart combo pill shows promise


It’s been a dream for a decade: a single daily pill combining aspirin, cholesterol medicine and blood pressure drugs — everything people need to prevent heart attacks and strokes in a cheap, generic form.

Skeptics said five medicines rolled into a single pill would mean five times more side effects. Some people would get drugs they don’t need, while others would get too little. One-size-fits-all would turn out to fit very few, they warned.

Now the first big test of the “polypill” has proved them wrong.

The experimental combo pill was as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a person’s risk of heart disease and stroke roughly in half, the study concludes.

The approach needs far more testing — as well as approval from the Food and Drug Administration, something that could take years — but it could make heart disease prevention much more common and more effective, doctors say.

The polypill also has big psychological advantages, said Dr. James Stein of the University of Wisconsin-Madison.

“If you take any medicines, you know that every pill you see in your hand makes you feel five years older. Patients really object to pill burden” and respond by skipping doses, he said.

No price for the polypill has been disclosed, but its generic components cost only a total of $17 a month now and doctors expect the combo would sell for far less.

The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. John’s Medical College in Bangalore, India. The findings were presented Monday at the cardiology college’s conference in Florida and published online by the British medical journal Lancet.

The study tested the Polycap, an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, India. It contains low doses of three blood pressure medicines (atenolol, ramipril and the “water pill” thiazide), plus the generic version of the cholesterol-lowering statin drug Zocor, and a baby aspirin (100 milligrams).

Formulating a single pill of five drugs that work in five different ways is a complex task — more complex than simply mixing the medicines. Pills have coatings and other ingredients that control the rate at which the medicine is released into the bloodstream. The polypill must be designed so that the five drugs work as intended.

The Polycap is the furthest along, and this is the largest study of one so far.

The study involved about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease — high blood pressure, high cholesterol, obesity, diabetes or smoking.

Four hundred were given the polypill. The rest were placed in eight groups of 200 and given individual components of the pill or various combinations. Treatment lasted 12 weeks.

Collectively, the results show the polypill could cut the risk of heart disease by 62 percent and the risk of stroke by 48 percent, based on what previous studies show from lowering risk factors by these amounts, the study concludes.

A bigger study is now needed to see whether the polypill actually does cut heart attacks and strokes, he wrote in a commentary in the medical journal.

A polypill also would need FDA approval, even though all of its components have long been sold separately. And establishing the proper doses could become a regulatory nightmare, Cannon warned.

Salvia Becomes Illegal in Ohio April 1st


Police are gearing up for a new front in the war on drugs: salvia, the hallucinogenic plant, becomes illegal in Ohio, one week from today. Commander John Burke of the Warren County Drug Task Force had a roomful of officers in training today. He kicked off the meeting with a primer on salvia....a leafy drug that becomes an illegal drug in Ohio next week.

Cmdr, John Burke, Warren County Drug Task Force: "There's been some incidents in Ohio and across the country with Salvia where, I believe even some deaths associated with it... not necessarily deaths from the drug, but behavior that occurs afterwards."

Videos on youtube show reactions to high doses of salvia. The plant is readily available for mail order on several websites that deliver to all but a handful of states. Officers asked if it shows up on drug screens, what it smells like when burned, and if K-9's could sniff it out. The answer was we just don't know. Police say they have no idea how popular salvia is and what making it illegal will ultimately do.

The people who sell it say it is extremely popular. This store sells five thousand dollars of salvia every month. The smoke store sells a brand called purple sticky that, depending on the potency, goes for 21.95 to 95 dollars a gram. The owner says it's really caught on with people 25 to 35.

Sales stop next Monday. Police say that's when they'll know just what they're dealing with.

"March 31st at 11:59 pm it'll be legal and at midnight it won't. And that's when we'll see how much in demand this is."

A bill to outlaw salvia was introduced in the Kentucky house last month, but failed to move forward. There are no regulations in Indiana. Next week, it will be a felony of the fifth degree to possess salvia in Ohio. The illegal salvia is a cousin of the flowering salvia that many people plant in local gardens. The illegal variety is native to Mexico and Central America and wouldn't survive outdoors in Ohio.

Posted: 3/26/2009 4:19:00 PM

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Expanded FDA approval on Symbyax and Lexapro


Drug developer Eli Lilly & Co. said Monday the Food and Drug Administration approved the bipolar depression drug Symbyax as a therapy for treatment-resistant depression.

The new indication applies to adult patients who have not responded to two separate rounds of therapy with different antidepressants.

The FDA also approved the combined use of Zyprexa and fluoxetine, or Prozac, as a treatment for depression and treatment-resistant depression. Zyprexa is already approved for schizophrenia and bipolar disorder.

And from PR Newswire - Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents:

Forest Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents, 12 - 17 years of age. Lexapro is only the second antidepressant to be approved for the treatment of MDD in adolescents, a medical condition that affects approximately 2 million adolescents in the U.S.

"Major depressive disorder in adolescents is a debilitating, but treatable illness," said Howard Solomon, Chairman and Chief Executive Officer, of Forest. "We have long believed that Lexapro would be of benefit for the treatment of depression in adolescents and that is why we undertook the several studies described in the package insert. We are enormously gratified that Lexapro will be available for depressed adolescents who so much require the benefits which Lexapro has made available for depressed adults for the past seven years."

The approval of Lexapro for the treatment of adolescent depression was supported by two placebo-controlled studies, one conducted in adolescent patients taking Lexapro and one conducted in children and adolescents taking citalopram. In an 8-week flexible- dose, placebo-controlled study that compared Lexapro 10-20 mg/day to placebo in 12 to 17 year old patients reported in 2008, Lexapro showed statistically significant greater mean improvement from baseline, compared to placebo, on the Children's Depression Rating Scale-Revised (CDRS-R).

In another 8-week, flexible-dose, placebo-controlled study, children and adolescents 7 to 17 years of age treated with racemic citalopram 20-40 mg/day showed statistically significant greater mean improvement from baseline on the CDRS-R compared to patients treated with placebo. The positive results for this trial largely came from the adolescent subgroup. The FDA's determination of the efficacy of Lexapro in the acute treatment of MDD in adolescents was established, in part, on the basis of extrapolation from this study.

Although maintenance efficacy in adolescent patients has not been systematically evaluated, the FDA in its review concluded that maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients.

Lexapro was generally well tolerated. The overall profile of adverse reactions in pediatric patients was generally similar to that seen in adult studies and is described in the package insert.

Posted: 3/24/2009 12:13:00 PM

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Salvia Divinorum may have Medical Benefits

From NewDesignWorld:

Salvia Divinorum is very popular for its psychedelic effects. Many people have a misconception that the Salvia Divinorum is in the same class of drugs as marijuana and cocaine. Therefore, they believe that Salvia Divinorum should be made illegal. Salvia Divinorum is entirely different from other plants and drugs. In fact some studies indicate that Salvia Divinorum can be used to free a person from addiction to alcohol and other drugs. In addition, new research is unlocking the untapped medical potential of Salvia Divinorum.

Speaking about the medical benefits of Salvia Divinorum, the professionals of Black Hat Botanicals said, “Various research studies indicate that Salvia Divinorum has great healing potential. Ongoing laboratory trials are showing that this miraculous herb could be a remedy for several diseases and mental disorders. Alzheimer’s, schizophrenia, depression, insomnia, stress, indigestion, and chronic pain are some of the health issues that could one day be treated with the use of this herb, or its chemical constituents. Historically, Salvia Divinorum was widely used by the Mazatec Indians for centuries, who sought relief from rheumatism, anemia and headache.”

They added that, “With all this healing potential, it is unfortunate that Salvia Divinorum is being made illegal in certain states and countries." It is now well known that those who use Salvia Divinorum can experience visionary states of consciousness that some have called intense spiritual healing sessions. Salvia can be chewed, smoked or taken as tincture. When an individual uses Salvia, he can also experience uncontrollable and boisterous feelings of laughter. Taken in moderation, Salvia can be normalized as a "feel-good" drug, with effects similar to alcohol or nicotine.

Various researches are being conducted now to study the medical benefits of Salvia Divinorum. Scientists and professors from major American, European and Asian unversities, as well as private drug companies, are investigating the herb and its chemical components. Thomas Prisinzano, assistant professor of medicinal and natural products chemistry at the University of Iowa has said that, "You can give a rat free access to cocaine, give them free access to Salvinorin A, and they stop taking cocaine." Professor Bryan L. Roth, director of the National Institute on Mental Health’s Psychoactive Drug Screening Program, has said, "We think that drugs derived from the active ingredient could be useful for a range of diseases: Alzheimer’s, depression, schizophrenia, chronic pain and even AIDS or HIV." In addition, expert clinical pharmacologist John Mendelsohn's research has caused him to publicy delcare that "There may be some derivatives that could be made that would actually be active against cancer and HIV. At the present time, there are a lot of therapeutic targets that have many people excited." With so much excitement and interest in the medical research community about Salvia Divinorum, it is only a matter of time until novel, life-saving treatments are brought to market.

The future of Salvia Divinorum seems to be very promising in the field of medicine.

Posted: 3/23/2009 9:05:00 AM

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F.D.A. Panel Gives Nod to Alternative to Warfarin

From The New York Times:

For decades, an anticlotting drug called warfarin has dominated the market for oral medications used to treat blood clots that form in the veins. Now, there may finally be a new contender.

An advisory panel of the Food and Drug Administration voted on Thursday to recommend that the agency approve a new drug, called rivaroxaban, a joint venture between Bayer Healthcare Pharmaceuticals and Johnson & Johnson.

Johnson & Johnson has applied to the agency for approval to market the drug for short-term use in preventing deep-vein thrombosis and pulmonary embolism in patients undergoing total hip or knee replacement surgery. The agency typically follows the recommendation of such advisory panels composed of outside medical experts.

Industry analysts said the application to temporarily treat orthopedic surgery patients was just a warm-up.

The real money lies in treating millions of chronic patients for stroke prevention and post-acute coronary syndrome, said Rick Wise, an analyst with Leerink Swann.

“This is Act 1 of a multiact play,” said Mr. Wise, who estimated that the orthopedic use of the drug could generate sales of $150 to $200 million annually in the United States. “For Act 2, the prospects look to be much greater.”

Johnson & Johnson has just ended clinical trials of the drug for longer-term use in patients with acute coronary syndrome.

The advent of a challenger to warfarin, the category leader, has the potential to expand sales of drugs to treat thrombosis, or blood clots in veins. Doctors and patients have been looking for an alternative to warfarin because of its significant drawbacks. Common foods and medicines can decrease the efficacy of the drug, requiring patients to have frequent blood tests.

In 2008, Americans spent $304 million on the top three prescription thrombosis drugs, according to data from IMS Health, a health care information company.

But Bruce Nudell, an analyst with UBS Securities, has calculated that a new brand of drug able to supplant warfarin, an inexpensive generic version of which Americans take 1.5 billion doses every year, could eventually generate as much as $6 billion annually.

But the review of rivaroxaban was not without contention.

The drug makers reported that patients in clinical trials who took the pills had half the incidence of blood clots than people who had injections of an anticoagulant drug called enoxaparin. But they also reported that 24 study patients on rivaroxaban subsequently had major bleeding — the kind that can require surgical intervention — compared with 13 who had injections.

An F.D.A. statistician who analyzed the data said the drug was effective. But, because of increased risk of bleeding, the drug did not prove to be superior at preventing life-threatening blood clots or death, she said.

Other large drug companies, including Sanofi-Aventis, Pfizer and other firms are also developing anticlotting medications.

Posted: 3/20/2009 4:03:00 PM

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A Silenced Drug Study Creates An Uproar

From The Washington Post:

The study would come to be called "cursed," but it started out just as Study 15.

It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15's results suggested otherwise.

As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don't like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found -- and raised serious concerns about an entire new class of expensive drugs.

Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based AstraZeneca International -- including nearly $12 billion in the past three years.

The results of Study 15 were never published or shared with doctors, even as less rigorous studies that came up with positive results for Seroquel were published and used in marketing campaigns aimed at physicians and in television ads aimed at consumers. The results of Study 15 were provided only to the Food and Drug Administration -- and the agency has strenuously maintained that it does not have the authority to place such studies in the public domain.

AstraZeneca spokesman Tony Jewell defended the Seroquel research and said the company had disclosed the drug's risks. Since 1997, the drug's labeling has noted that weight gain and diabetes were seen in study patients, although the company says the data are not definitive. The label states that the metabolic disorders may be related to patients' underlying diseases.

The FDA, Jewell added, had access to Study 15 when it declared Seroquel safe and effective. The trial, which compared patients taking Seroquel and an older drug called Haldol, "did not identify any safety concerns," AstraZeneca said in an e-mail. Jewell added, "A large proportion of patients dropped out in both groups, which the company felt made the results difficult to interpret."

Details of Study 15 have emerged through lawsuits now playing out in courtrooms nationwide alleging that Seroquel caused weight gain, hyperglycemia and diabetes in thousands of patients. The Houston-based law firm Blizzard, McCarthy & Nabers, one of several that have filed about 9,210 lawsuits over Seroquel, publicized the documents, which show that the patients taking Seroquel in Study 15 gained an average of 11 pounds in a year -- alarming company scientists and marketing executives. A Washington Post analysis found that about four out of five patients quit taking the drug in less than a year, raising pointed doubts about its effectiveness.

An FDA report in 1997, moreover, said Study 15 did offer useful safety data. Mentioning few details, the FDA said the study showed that patients taking higher doses of the drug gained more weight.

In approving Seroquel, the agency said 23 percent of patients taking the drug in all studies available up to that point experienced significant weight increases, compared with 6 percent of control-group patients taking sugar pills. In 2006, FDA warned AstraZeneca against minimizing metabolic problems in its sales pitches.

In the years since, taxpayer-funded research has found that newer antipsychotic drugs such as Seroquel, which are 10 times as expensive, offer little advantage over older ones. The older drugs cause involuntary muscle movements known as tardive dyskinesia, and the newer ones have been linked to metabolic problems.

For practicing psychiatrists, Study 15 could have said a lot not just about safety but also effectiveness. Like all antipsychotics, Seroquel does not cure the diseases it has been approved to treat -- schizophrenia and bipolar disorder -- but controls symptoms such as agitation, hallucinations and delusions. When government scientists later decided to test the effectiveness of the class of drugs to which Seroquel belongs, they focused on a simple measure -- how long patients stayed on the drugs. Discontinuation rates, they decided, were the best measure of effectiveness.

Study 15 had three groups of about 90 patients each taking different Seroquel doses, according to an FDA document. Approximately 31 patients were on Haldol. The study showed that Seroquel failed to outperform Haldol in preventing psychotic relapses.

In disputing Study 15's weight-gain data, company officials said they were not reliable because only about 50 patients completed the year-long trial. But even without precise numbers, this suggests a high discontinuation rate among patients taking Seroquel. Even if every single patient taking Haldol dropped out, it appears that at a minimum about 220 patients -- or about 82 percent of patients on Seroquel -- dropped out.

Eight years after Study 15 was buried, an expensive taxpayer-funded study pitted Seroquel and other new drugs against another older antipsychotic drug. The study found that most patients getting the new and supposedly safer drugs stopped taking them because of intolerable side effects. The study also found that the new drugs had few advantages. As with older drugs, the new medications had very high discontinuation rates. The results caused consternation among doctors, who had been kept in the dark about trials such as Study 15.

The federal study also reported the number of Seroquel patients who discontinued the drug within 18 months: 82 percent.

Posted: 3/20/2009 2:04:00 PM

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New research suggests common anti-seizure medications may increase risk of cardiovascular problems

From EurekAlert!:

An important clinical repercussion in the treatment of epilepsy has been discovered by a research team led by Scott Mintzer, M.D., assistant professor in the Department of Neurology and the Jefferson Comprehensive Epilepsy Center at Jefferson Medical College of Thomas Jefferson University. The team has determined that two of the most commonly prescribed anti-seizure medications may lead to significantly increased levels of cholesterol, C-reactive protein and other markers of cardiovascular disease risk. The finding – set to be published in the March 18th online edition of Annals of Neurology – may help doctors manage the care of patients with seizures more effectively by prescribing different anti-seizure medications that will not adversely affect cardiovascular health.

The study involved two of the most widely-prescribed anticonvulsants – phenytoin (Dilantin®) and carbamazepine (Tegretol®, Carbatrol®) – which have potent effects on many enzymes in the body involved in different areas of metabolism. The researchers recruited 34 epilepsy patients taking either one of those two drugs who were being switched over to one of two newer anti-seizure drugs which do not widely affect enzymes – lamotrigine (Lamictal®) or levetiracetam (Keppra®). The goal was to determine if the change affected the patients' cholesterol levels and other key markers of cardiovascular disease.

Just 6 weeks after the patients' drugs were switched, there were significant declines in total cholesterol, non-high-density lipoprotein (commonly referred to as 'bad') cholesterol, triglycerides and C-reactive protein, suggesting the older, commonly-used drugs might substantially increase the risk of cardiovascular disease.

"The epilepsy patients in this study saw a rapid and clinically significant improvement in several markers related to cardiovascular disease, including a decrease in total cholesterol that averaged 26 points. This is almost certainly not due to some positive effect from the new drugs. It's a consequence of being taken off the older ones, which were causing the cholesterol and other markers to be elevated in the first place," said Dr. Mintzer. "While more investigation is needed, these results may help physicians better understand the risks of these drugs and choose the most appropriate treatment for their epilepsy patients, especially those who are already at risk for cardiovascular disease or have a family history of it."

According to the Epilepsy Foundation, which also funded this study, there are almost three million people living with epilepsy with an additional 200,000 new diagnoses being made each year. Dilantin is the most commonly prescribed anticonvulsant in this country, and has been since its discovery in 1938. Throughout the industrialized world, Tegretol has been the most commonly prescribed anticonvulsant for more than 20 years. The results of this study could have far-reaching effects on how the millions of current, and future patients are, or will be, treated.

Posted: 3/19/2009 3:06:00 PM

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Admissions for Prescription Painkiller Abuse on Rise

From HealthDay:

Admissions for treatment of prescription painkiller abuse in the United States have risen dramatically over the past decade, from 1 percent of all substance abuse admissions in 1997 to 5 percent in 2007, according to a government report released Tuesday.

Alcohol was still the leading cause (40 percent) of the 1.8 million substance abuse treatment admissions in 2007, but has declined from 50 percent in 1997, said the Substance Abuse and Mental Health Services Administration report.

Among the other findings in the Treatment Episode Data Set (TEDS) 2007:

--The percentage of admissions primarily due to heroin use was about the same in 2007 as it was in 1997 -- 14 percent.

--The percentage of admissions primarily due to methamphetamine/amphetamine abuse was 4 percent in 1997, rose to 9 percent in 2005, then decreased to 8 percent in 2006 and 2007.

--Admissions for marijuana abuse increased from 12 percent in 1997 to 16 percent in 2003 and have remained steady since then.

"The TEDS report provides valuable insight into the true nature and scope of the challenges confronting the substance abuse treatment community. By carefully analyzing this data, the public health community can better anticipate and address emerging needs," Dr. Eric Broderick, SAMHSA acting administrator, said in an agency news release.

The TEDS report provides demographic and other information on substance abuse treatment admissions from state-licensed treatment facilities across the United States. It doesn't include information on all treatment admissions but is the largest, most comprehensive study of its kind, according to the news release.

Posted: 3/18/2009 2:13:00 PM

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Probable Carcinogens Found in Baby Toiletries

From The Washington Post:

More than half the baby shampoo, lotion and other infant care products analyzed by a health advocacy group were found to contain trace amounts of two chemicals that are believed to cause cancer, the organization said yesterday.

Some of the biggest names on the market, including Johnson & Johnson Baby Shampoo and Baby Magic lotion, tested positive for 1,4-dioxane or formaldehyde, or both, the nonprofit Campaign for Safe Cosmetics reported.

The chemicals, which the Environmental Protection Agency has characterized as probable carcinogens, are not intentionally added to the products and are not listed among ingredients on labels. Instead, they appear to be byproducts of the manufacturing process. Formaldehyde is created when other chemicals in the product break down over time, while 1,4-dioxane is formed when foaming agents are combined with ethylene oxide or similar petrochemicals.

The organization tested 48 baby bath products such as bubble bath and shampoo. Of those, 32 contained trace amounts of 1,4-dioxane and 23 contained small amounts of formaldehyde. Seventeen tested positive for both chemicals.

"Our intention is not to alarm parents, but to inform parents that products that claim to be gentle and pure are contaminated with carcinogens, which is completely unnecessary," said Stacy Malkan, a spokeswoman for the Campaign for Safe Cosmetics, which is calling for the government to more strictly regulate personal care products such as shampoo, lotion and makeup.

Companies that manufacture and sell the products tested by the group stressed that they comply with government standards.

"The FDA and other government agencies around the world consider these trace levels safe, and all our products meet or exceed the regulatory requirements in every country where they are sold," Johnson & Johnson said in a statement. "We are disappointed that the Campaign for Safe Cosmetics has inaccurately characterized the safety of our products, misrepresented the overwhelming consensus of scientists and government agencies that review the safety of ingredients, and unnecessarily alarmed parents."

The European Union has banned 1,4-dioxane as an ingredient in personal care products, but the Food and Drug Administration has not established a safe limit for the chemical in shampoo, lotion and other toiletries. It maintains that the trace amounts found in those products are not harmful.

A 1982 study by the FDA showed that 1,4-dioxane can penetrate human skin when used in lotion.

Health advocates argue, however, that federal regulators have not considered the cumulative effect of chemicals in personal care products.

"The levels we've found are relatively low, and the industry often says there's just a little bit of carcinogen in my product," Malkan said. "The problem is, we're finding a little bit of carcinogen in many products. Many of these products are used every day, so we've got repeated and frequent exposure to these low levels of chemicals. They're not the safest and purest products, and parents ought to know that."

In addition, government studies have not examined the effect of chemical exposure on the particular vulnerabilities of infants and children, whose bodies are still developing, the advocates said.

Several Democratic lawmakers said the report is evidence that the nation's chemical regulation system needs to be changed.

And from USA Today, a full list of products tested.

Posted: 3/17/2009 11:41:00 AM

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10 kids drink windshield wiper fluid at daycare


Child welfare investigators plan to talk to the owner of an Arkansas daycare center where 10 children were sickened after they were given windshield wiper fluid to drink.

Hospital officials say a staffer mistakenly put the blue liquid in the refrigerator after shopping and later served it thinking it was Kool-Aid. Doctors estimate the children, ages 2 to 7, drank about an ounce of the fluid.

Only one child remained hospitalized Friday morning after blood samples showed "measurable levels" of methanol, a highly toxic alcohol that can induce comas and cause blindness, officials said.

Arkansas’ Department of Human Services said depending on the results of the investigation, the daycare operator Carolyn Bynum could have her license revoked or suspended.

Bynum had a state license to care for 10 children in her home and had no found complaints or serious compliance issues in the past, Munsell said.

The toxicologist warned that many antifreeze or windshield wiper solutions have bright colors, which can be mistaken for fruit drinks.

"I think the take-home message is not to have these products in the kitchen or where you're doing any kind of food preparation," she said.

Posted: 3/13/2009 12:08:00 PM

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