FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers

Two U.S. Food and Drug Administration advisory committees plan to meet Tuesday and Wednesday to decide whether to recommend that the dosing instructions on the labels of medicines containing acetaminophen need to be fine-tuned to protect children under the age of 2 against possible liver failure and even death. Currently, the labels of such fever-reducing medications, which include Children's Tylenol, have dosing instructions for children aged 2 and up. For kids under 2, the labels simply tell parents to "ask a doctor." The American Academy of Pediatrics (AAP) and drug manufacturers are both strongly in favor of giving parents the additional dosing information.

"If we give parents better information, they will be able to give enough of the medicine to work well, at the same time minimizing the side effects," said Dr. Daniel Frattarelli, a pediatrician in Dearborn, Mich. who chairs the academy's drug committee and who plans to testify before a joint, two-day meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. "Parents want to do the right thing for their children," he said. "We as a medical community have to give them that information so they are able to do this." Although the evidence shows that acetaminophen is safe for young children, parents have to be careful with it, pediatricians noted. Giving too much can be toxic to the liver, causing poisoning and even liver failure.

In 2010, there were 270,000 reported overdoses of acetaminophen, according to the American Association of Poison Control Centers. Dosing errors involving children's acetaminophen products accounted for almost 7,500 cases nearly 3 percent. In an ideal world, the parents of infants and toddlers would still consult with their pediatrician or pharmacist to get the proper medication dosing, said Dr. William Basco, director of general pediatrics at the Medical University of South Carolina. But the reality is that many parents aren't doing that and are instead guessing about proper dosing. "There is no benefit to having parents guess at the right dose," Basco said.

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Genome Scans May Reveal Life-Saving Alternatives for Cancer Patients

A 39-year-old woman is referred to Washington University's Siteman Cancer Center in St. Louis with suspected acute myeloid leukemia (AML), a cancer that can be treated relatively simply with medication, or not so simply with a high-risk stem cell transplant, depending on the tumor subtype. But finding out which type of cancer she has proves trickier than expected. While the pathologist sees a type of leukemia known as M3AML, which generally has a good outcome and can be treated with the drug ATRA, the cytogeneticist sees something entirely different.

In his analysis, the woman has a type of leukemia with poor long-term survival that is usually treated with stem cell transplantation a risky therapy that sometimes leads to death. Fortunately, in this case study, documented in the April 20 issue of the Journal of the American Medical Association, the woman's oncologist is aware of a clinical trial and, deferring treatment for six weeks, refers her there so the researchers can do a full scan of her genome and come up with an answer.

Full-genome sequencing involves scanning all the thousand of genes on the human genome to try to find a mistake. It's different from the more common gene testing these days, which looks only for specific DNA that might or might not be responsible for a particular problem. In the St. Louis case, the more in-depth sequencing, done in only seven weeks, uncovered a new genetic "mistake" that showed the woman could be treated with ATRA and not the more-complicated, risky stem cell transplantation.

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Starting HIV Drugs Earlier May Delay AIDS But Not Death

New research suggests that HIV-infected patients are most likely to stay clear of AIDS longer if they start drug therapy when their immune systems are still relatively strong. However, starting treatment earlier, compared to waiting, didn't affect dying from AIDS. "There wasn't a clear benefit in terms of preventing death" by prescribing the drugs before some guidelines suggest, said Dr. Keith Henry, director of HIV clinical research at Hennepin County Medical Center in Minneapolis and co-author of a commentary accompanying the study, published in the April 19 edition of Annals of Internal Medicine.

The issue of when to begin drug treatment is a hot topic in the field of AIDS/HIV medicine. If physicians wait to begin treatment, patients can delay the expense not to mention the side effects of pricey anti-HIV drugs. But such delays may also give the virus a chance to become more powerful and better able to fend off medications. If they're not treated with drugs, HIV-infected people almost always go on to develop AIDS. So when should doctors turn to the drugs? In the U.S., guidelines suggest that HIV-infected patients take them when the level of CD4 cells an important part of the immune system dips below 0.500 X 109 cells per liter (cells/L).

In Europe, the guideline number is frequently lower meaning a weaker immune system at under 0.350 X 109 cells/L.In the new study, researchers examined how patients did when they began drug therapy with their CD4 cells at a variety of levels. The study authors examined the medical records of almost 21,000 HIV-infected patients who sought treatment in HIV clinics in Europe and through the Veterans Health Administration system in the United States. The researchers found that the death rate was about the same regardless of whether patients began treatment when their CD4 levels dipped under 0.500 X 109 cells/L or if they waited until their immune systems deteriorated more and reached below the level of 0.350 X 109 cells/L.

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Do Immune System Ills Help Drive Type 2 Diabetes?

New research suggests that the development of insulin resistance and type 2 diabetes may be linked to an immune system reaction gone awry. "The main point of this study is trying to shift the emphasis in thinking of type 2 diabetes as a purely metabolic disease, and instead emphasize the role of the immune system in type 2," said study co-author Dr. Daniel Winer, an endocrine pathologist at Toronto General Hospital in Canada. When the research began, Winer was a postdoctoral fellow at Stanford University in California. The researchers have identified immune system antibodies in people who are obese and insulin-resistant that aren't present in people who are obese without insulin resistance. They also tested a drug that modifies the immune system in mice fed a fatty diet, and found that the medication could help maintain normal blood sugar levels.

The findings were published online April 17 in the journal Nature Medicine. Funding for the study was provided by the U.S. National Institutes of Health. Nearly 26 million Americans have diabetes, according to the U.S. Centers for Disease Control and Prevention. Between 90 percent and 95 percent of these cases are type 2 diabetes, where the body doesn't use insulin efficiently, so the pancreas must make increasing amounts of insulin. Eventually, the pancreas stops making enough insulin to meet the increased demand. The less common form of the disease, type 1 diabetes, occurs when the immune system mistakenly destroys the insulin-producing beta cells in the pancreas. This type of diabetes is considered an autoimmune disease, and isn't linked to how much a person weighs.

Although the causes of type 2 haven't been clear, it's known that the disease runs in families, suggesting a genetic component. Also, while type 2 is strongly linked to increased weight, not everyone who is overweight gets type 2 diabetes. And, that's what got the researchers searching for another factor. Winer explained that excess weight has been linked to inflammation, which can cause the immune system to react. As visceral fat (abdominal fat) expands, it eventually runs out of room, explained Winer. At that point, the fat cells may become stressed and inflamed, and eventually the cells die. When that happens, immune system cells known as macrophages come to sweep up the mess.

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Few Stroke Patients Given Clot-Buster Quickly Enough: Study

Few eligible stroke patients get an injectable clot-busting drug within the recommended 60-minute window after their hospital arrival, new research finds. "It has been widely recommended that the 'door-to-needle' time should be 60 minutes," said study author Dr. Gregg C. Fonarow, a professor of cardiovascular medicine at the University of California Los Angeles David Geffen School of Medicine. The phrase refers to the timeframe between when the patient arrives at the hospital and when that patient is given the clot-buster, known as tissue plasminogen activator (tPA).

In his analysis of stroke patients from 1,083 hospitals, he found the 60-minute window was not the typical reality. "That occurs only in 26.6 percent of patients," he said. Fonarow was slated to present the findings Thursday at the American Stroke Association's International Stroke Conference in Los Angeles; the research is being published simultaneously in the journal Circulation. Perhaps even more surprising, the hospitals in the study were all participating in the American Heart Association/American Stroke Association's Get with The Guidelines-Stroke quality improvement program, which recommends early tPA administration.

"It involved some of the largest, best-known hospitals for stroke care," Fonarow said. The study looked at more than 25,500 patients who had suffered ischemic stroke in which a blood clot obstructs blood flow and had been treated with tPA within three hours of the start of symptoms. Just 6,790 got the intravenous drug within 60 minutes. During the course of the study, there was only modest improvement in the hospitals' track records.

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Breast Cancer Treatment May Lead to Hip Fracture

Middle-aged breast cancer survivors face an increased risk for hip fractures, a condition normally uncommon in women younger than 70, a new study has found. Researchers at Northwestern University in Chicago say that this may be because early menopause caused by breast cancer treatment and the effects of breast cancer drugs could weaken the bones by the time women reach middle age. The finding came from a study of six women who had survived breast cancer and, in their early 50s, were being treated for hip fractures.

Most of the women did not have osteoporosis, but they did have lower-than-normal bone mineral density (osteopenia). This suggests that rapid changes in bone architecture caused by chemotherapy, early menopause and adjuvant breast cancer therapy may not be detected on a bone mineral density test, said Dr. Beatrice Edwards, an associate professor of medicine and orthopedic surgery and director of the bone health and osteoporosis program Northwestern University's Feinberg School of Medicine, who led the research.

The women had been diagnosed with early-stage breast cancer, and their treatments had included lumpectomy, radiation therapy and chemotherapy with cytoxan and adriamycin for one to four years before they broke a hip. All of the women were perimenopausal at the time of the fracture. In four of the women, their breast cancer had grown in response to estrogen, and their cancer therapy had included aromatase inhibitors to prevent their bodies from making estrogen. Recent research has linked aromatase inhibitors with possible bone loss in women.

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New Drug Strategy Shows Promise Against HIV

Scientists are reporting early but promising results from a new drug that blocks HIV as it attempts to invade human cells. The approach differs from most current antiretroviral therapy, which tries to limit the virus only after it has gained entry to cells. The medication, called VIR-576 for now, is still in the early phases of development. But researchers say that if it is successful, it might also circumvent the drug resistance that can undermine standard therapy, according to a report published Dec. 22 in Science Translational Medicine.

The new approach is an attractive one for a number of reasons, said Dr. Michael Horberg, director of HIV/AIDS for Kaiser Permanente in Santa Clara, Calif. "Theoretically it should have fewer side effects and there's probably less of a chance of mutation in developing resistance to medication," said Horberg, who was not involved in the study. Viruses replicate inside cells and scientists have long known that this is when they tend to mutate potentially developing new ways to resist drugs. "It's generally accepted that it's harder for a virus to mutate outside cell walls," Horberg explained.

The new drug focuses on HIV at this pre-invasion stage. "VIR-576 targets a part of the virus that is different from that targeted by all other HIV-1 inhibitors," explained study co-author Frank Kirchhoff, a professor at the Institute of Molecular Virology, University Hospital of Ulm in Ulm, Germany, who, along with several other researchers, holds a patent on the new medication. The target is the gp41 fusion peptide of HIV, the "sticky" end of the virus's outer membrane, which "shoots like a 'harpoon'" into the body's cells, the authors said. The launch of this peptide is a first step in the virus's bid to inhabit host cells.

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Bone Drug Zometa Flops Overall as Breast Cancer Treatment

The bone drug zoledronic acid, considered a potentially promising weapon against breast cancer recurrence, has flopped in a new study involving more than 3,360 patients. The drug, long used to combat bone loss from osteoporosis, did not appear to prevent breast cancer from returning or to boost disease free survival overall. British researchers presented the disappointing findings Thursday at the San Antonio Breast Cancer Symposium in Texas.

"As a whole, the study is negative," study author Dr. Robert Coleman, a professor of medical oncology at the University of Sheffield in England, said during a Thursday news conference on the findings. "There is no overall difference in recurrence rates or survival rates, except in older patients, defined as more than five years after menopause." That was a possible bright spot in the results.

"In that population, there is a benefit," Coleman said. The older women had a 27 percent improvement in recurrence and a 29 percent improvement in overall survival over the five-year follow-up, compared to those who didn't get the drug. "There was tremendous hope that this [drug] approach would be a major leap forward," Coleman noted. "There have been other trials that suggest this is the case." In one previous study, the use of the drug was linked with a 32 percent improvement in survival and lowered recurrence in younger women with breast cancer.

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Blood Cancer Advances May Improve Survival

Advances in the treatment of blood cancers offer new hope for increased survival, according to two studies scheduled to be presented at the American Society of Hematology meeting Saturday in Orlando, Fla. Results from one study suggest that treating multiple myeloma patients with zoledronic acid can improve survival, while another group of researchers are scheduled to report on their progress in treating a particularly aggressive form of acute lymphoblastic leukemia (ALL).

Zoledronic acid, a type of bisphosphonate, is given to myeloma patients to bolster bone health and reduce the risk for fracture and bone pain that are a common feature of the disease.Although prior research has suggested that zoledronic acid may have a broader anti-cancer effect, the current study finds that a well-tolerated regimen of the drug can reduce the risk of death among myeloma patients.The study is published in the Dec. 4 online edition of The Lancet.

"These data add to growing clinical evidence supporting anti-cancer benefits with zoledronic acid in patients with newly diagnosed cancers," the study team, led by Gareth J. Morgan from the Institute of Cancer Research in London, said in a journal news release. The authors base their conclusions on work with 1,960 multiple myeloma patients, about half of whom were treated with zoledronic acid in combination with either intensive or non-intensive chemotherapy. The other half received clodronic acid and equivalent chemotherapy regimens.

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Common Epilepsy Drug Taken During Pregnancy Might Raise Spina Bifida Risk

Pregnant women with epilepsy who are taking carbamazepine (Tegretol) to control seizures may be at a slightly increased risk of having an infant with spina bifida, a new study finds. Spina bifida is a condition in which the bones of the spine do not close but the spinal cord remains in place, usually with skin covering the defect. Most children will need lifelong treatment for problems arising from damage to the spinal cord and spinal nerves.

"For women with epilepsy, seizure control during pregnancy is very important," said lead researcher Lolkje de Jong van den Berg, from the division of pharmacy at the University of Groningen in the Netherlands. "Our study can help in decisions regarding whether carbamazepine should be the drug of choice in pregnancy." However, the best option regarding treatment can be chosen only on an individual basis by the woman and her neurologist before pregnancy, weighing the benefits of epilepsy control against the risk of birth defects, de Jong-van den Berg said.

The report is published in the Dec. 3 online edition of the BMJ. For the study, de Jong-van den Berg's team reviewed existing research to determine the risk of birth defects among women taking Tegretol. The researchers found that infants of women taking Tegretol were 2.6 times more likely to have spina bifida, compared with women not taking any anti-epileptic medication.

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FDA Panel to Vote on Drugs Said to Prevent Prostate Cancer

A U.S. Food and Drug Administration advisory panel is expected to decide Wednesday whether to approve two drugs for the prevention of prostate cancer, the third highest cancer killer of men. Avodart and Proscar, manufactured by GlaxoSmithKline and Merck, respectively, are already approved to treat enlarged prostates. The drug makers say their research shows the drugs also lower the risk of prostate cancer by more than 20 percent. FDA regulators have several concerns, the Associated Press reported. For one thing, black men, who are at high risk for the disease, were underrepresented in the clinical trials.

"The applicability to African-American men is not known due to marked under-representation," the FDA's online review stated. Blacks made up just 4 percent of Merck's patients and only 2 percent of Glaxo's patients, according to the AP. The panel of outside experts assembled by the FDA is also likely to discuss the overall value of preventing low-grade tumors. According to the FDA, more than three-quarters of the tumors the drugs prevent are slow-growing, meaning they are non-aggressive and probably not life-threatening for anyone with a life expectancy of less than 20 years.

If the tumors aren't aggressive, Glaxo has said they often involve unnecessary treatment and biopsies, or surgical procedures, to diagnose cancer, that pose risks of their own. Also, slightly more aggressive tumors were seen in men taking Avodart and Proscar, compared with those taking placebo pills, according to the FDA. But the pharamaceutical companies say the drugs simply make those tumors easier to detect because they shrink the prostate. The U.S. National Cancer Institute estimates that 217,730 men will be diagnosed with prostate cancer this year and 32,050 men will die of it.

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Mental Illness Hit 1 in 5 U.S. Adults in Past Year

A new survey finds that 20 percent of U.S. adults over 45 million people experienced mental illness in the past year. Overall, 4.8 percent suffered serious mental illness, 8.4 million people had serious thoughts of suicide, 2.2 million made suicide plans, and one million attempted suicide, according to the 2009 National Survey on Drug Use and Health. Nearly 20 percent of adults with mental illness in the past year also had a substance abuse disorder, the report found. The rate was 25.7 percent for those with a serious mental illness about four times higher than the rate of 6.5 percent among people without a serious mental illness,

The survey, which included 67,500 adults nationwide, was released Thursday by the Substance Abuse and Mental Health Services Administration.

Among its other findings:

* Mental illness is more common among jobless people (27.7 percent) than among those with full-time jobs (17.1 percent).

* Women are more likely than men to experience mental illness 23.8 percent vs. 15.6 percent.

* Young adults had the highest rate of mental woes (30 percent) while those aged 50 and older had the lowest rate (13.7 percent).

* Overall, only 37.9 percent of adults with mental illness received mental health services.

* While the use of mental health services was highest among those with serious mental illness (60.2 percent), 4.4 million adults with serious mental illness in the past year did not receive the services they needed.

"Too many Americans are not getting the help they need and opportunities to prevent and intervene early are being missed," SAMHSA Administrator Pamela S. Hyde said in an agency news release. "The consequences for individuals, families and communities can be devastating. If left untreated mental illnesses can result in disability, substance abuse, suicides, lost productivity, and family discord. Through health care reform and the Mental Health Parity and Addiction Equity Act we can help far more people get needed treatment for behavioral health problems," she said.

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FDA Expected to Ban Caffeinated Alcohol Drinks

The U.S. Food and Drug Administration was set to rule Wednesday on the safety of caffeinated alcoholic beverages that have reportedly left dozens of young adults sick or hospitalized. The announcement comes amid a growing backlash against so-called energy drinks that mix caffeine and alcohol, even though such beverages are becoming increasingly popular with college students and even children. The drinks are regularly consumed by 31 percent of 12- to 17-year-olds and 34 percent of 18- to 24-year-olds, the U.S. Centers for Disease Control and Prevention estimates.

New York Sen. Charles Schumer, who has supported a ban on the drinks that are marketed under such names as Four Loko and Joose, reported Tuesday on his Web site that the FDA would outlaw the products because they are an "unsafe food additive to alcoholic beverages." Schumer, a Democrat, also said the Federal Trade Commission planned to notify manufacturers that "they are engaged in the potential illegal marketing of unsafe alcoholic drinks." Meanwhile, the maker of Four Loko said Tuesday that it would remove caffeine and other stimulants from its four different flavors of alcoholic drinks.

Four Loko has up to 12 percent alcohol in a 23.5-ounce can, according to published reports. Four Loko's manufacturer, Chicago-based Phusion Projects, insists that the drinks are safe. But, in a statement posted on the company's Web site, it said it was removing the caffeine "after trying unsuccessfully to navigate a difficult and politically charged regulatory environment at both the state and federal levels." The company said it doesn't agree that mixing caffeine and alcohol is inherently unsafe.

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'Stop Smoking' Ads That Target Emotions Seem to Work Best

Television ads that encourage people to quit smoking are most effective when they use a "why to quit" strategy that includes either graphic images or personal testimonials, a new study suggests. The three most common broad themes used in smoking cessation campaigns are why to quit, how to quit and anti-tobacco industry, according to scientists at RTI International, a research institute. The study authors examined how smokers responded to and reacted to TV ads with different themes. They also looked at the impact that certain characteristics such as cigarette consumption, desire to quit, and past quit attempts had on smokers' responses to the different types of ads.

"While there is considerable variation in the specific execution of these broad themes, ads using the 'why to quit' strategy with graphic images or personal testimonials that evoke specific emotional responses were perceived as more effective than the other ad categories," lead author Kevin Davis, a senior research health economist in RTI's Public Health Policy Research Program, said in an institute news release. Davis and his colleagues also found that those who had less desire to quit and those who had not tried quitting in the past year had significantly less favorable responses to all types of smoking cessation ads. The same was true, to a lesser extent, for smokers with high levels of cigarette consumption.

"These findings suggest that smokers clearly differ in their reactions to cessation-focused advertising based on their individual desire to quit, prior experience with quit attempts and, to a lesser degree, cigarette consumption. These are important considerations for campaign creators, designers and media planners," Davis said. The study, published online in the journal Tobacco Control, used data from 7,060 adult smokers in New York State who took part in an online survey. On Wednesday, the U.S. Food and Drug Administration announced a new "comprehensive tobacco control strategy" that would include not only graphic photos on packs of cigarettes, but bold statements such as "Smoking Will Kill You."

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Diabetes Drugs Might Lower Risk of Lung Cancer

Researchers report that drugs used to treat diabetes may indeed both prevent and contain lung cancer. The findings, being presented Tuesday at the annual meeting of the American College of Chest Physicians in Vancouver, back up preliminary data that some diabetes medications might protect against tobacco-induced lung cancer. "Patients who did not develop lung cancer had a much higher chance of taking one of these medications than those who did develop lung cancer," said study author Dr. Peter Mazzone. "And those who did develop lung cancer were much less likely to have seen that cancer spread outside the chest and more likely to survive longer with one of these drugs."

Both metformin and the class of drugs known as thiazolidinediones (which includes Avandia and Actos) are used by tens of millions of Americans. A mouse study published in September found that metformin was associated with up to a 73 percent reduction in the number of tumors mice developed when they were given a common carcinogen found in tobacco. The mice had been genetically engineered to be susceptible to this kind of tumor. Epidemiological studies in humans have found similar effects. Metformin was originally marketed as Glucophage, but is now available as an inexpensive generic.

For this study, Mazzone and his colleagues reviewed and compared electronic medical records on 225 diabetics with lung cancer with a similar number of diabetic patients who did not have lung cancer, although both groups shared other risk factors such as age, smoking history and gender. "Forty-one percent of those with lung cancer had taken one of these medications at some point prior to developing the cancer, and 96 percent of all the controls had taken one of these medications in diabetic treatment," reported Mazzone, director of the lung cancer program at The Respiratory Institute at the Cleveland Clinic in Ohio.

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Doctors Ordering Transfusions to Get Patients into Drug Trials

Canadian researchers say they've noticed a disturbing trend: Cancer doctors ordering unnecessary blood transfusions so that seriously ill patients can qualify for drug trials. In a letter published recently in the New England Journal of Medicine, the researchers report on three cases during the last year in Toronto hospitals in which physicians ordered blood transfusions that could make the patients appear healthier for the sole purpose of getting them into clinical trials for chemotherapy drugs. The practice raises both medical and ethical concerns, the authors say.

"On the physician side, you want to do the best for your patients," said co-author Dr. Jeannie Callum, director of transfusion medicine and tissue banks at Sunnybrook Health Sciences Centre in Toronto. "If these patients have no other options left to them, you want to do everything you can to get them into a clinical trial," she said. "But the patient is put in a horrible position, which is, 'If you want in to the trial, you have to have the transfusion.' But the transfusion only carries risks to them," she added.

A particularly serious complication of blood transfusions is transfusion-related acute lung injury, which occurs in about one in 5,000 transfusions and usually requires the patient to go on life support, said Callum. But besides the potential for physical harm, enrolling very sick people in a clinical trial can also skew the study's results making the drug perform worse than it might in patients whose disease was not as far along. The unnecessary transfusions were discovered by the Toronto Transfusion Collaboration, a consortium of six city hospitals formed to carefully review all transfusions as a means of improving patient safety, Callum said.

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Teens, Parents Often Lie About Illicit Drug Use

Don't expect teens or their parents to be honest about their drug use, a new study shows. Researchers often survey teens to determine the extent of drug use, but this new research finds that respondents frequently lie even if they know they'll be tested for drugs or they're told the results will be confidential.The findings are important for pediatricians to understand, said study lead author Dr. Virginia Delaney-Black. "If you think it's important to know whether a kid is doing drugs specifically heroin, prescription pain killers or cocaine then don't rely on what the teens report," she said.

Perhaps some folks don't trust the confidentiality agreement; others may think their behavior is no one else's business or they may fear reprisal. "Many of us feel that this kind of personal information is personal, and that we don't have to tell other people what the truth is," said Delaney-Black, a professor of pediatrics at Children's Hospital of Michigan. For this study, researchers surveyed more than 200 teens and 200 caregivers 80 percent were mothers about their drug use and then analyzed their hair for at least one drug. The participants were black, poor and from an inner-city urban area.

The study findings, reported in the November print issue of the journal Pediatrics, were published online Oct. 25. No teens said they'd recently used opiates such as heroin or prescription painkillers, but the hair tests showed that nearly 7 percent had. Among parents, 3 percent admitted using opiates while testing revealed use by 7 percent. About 1 percent of teens reported recent cocaine use, while testing revealed the actual number was about one-third. Hair analysis showed 28 percent of parents had used cocaine but only about 6 percent admitted it.

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Kids Under 6 Account for Two-Thirds of Drug-Related ER Visits

Children aged 5 years or younger accounted for 68.9 percent of the estimated 100,340 U.S. emergency department visits in 2008 that involved accidental ingestion of prescription medicines and other drugs, says a U.S. government report. About two-fifths of these children were 2 years old and 29.5 percent were 1 year old. Males accounted for 55.7 of the cases, according to the Drug Abuse Warning Network (DAWN) report released by the Substance Abuse and Mental Health Services Administration.

Pharmaceuticals were involved in 99 percent of cases involving young children, while illicit drugs or alcohol were involved in only 1 percent. "While caretakers may be alert to securing obviously dangerous substances such as cleaning products and chemicals, they may be less aware of the danger of leaving pharmaceutical products belonging to parents or other family members in accessible places," noted the agency in a press release. "This can pose a serious threat of accidental ingestion by infants and toddlers."

Drugs that act on the central nervous system such as acetaminophen products, ibuprofen products, and benzodiazepines were involved in 40.8 percent of the cases. Of these cases, most involved pain relievers and anxiety and insomnia drugs. Other types of drugs accidentally ingested by young children included cardiovascular medications, respiratory system medications, antidepressants and antipsychotics , topical medications and drugs for metabolic disorders. The report said that most of the youngsters were treated and released, while 8.7 percent were admitted to the hospital. Of those, about 20 percent were admitted to the intensive or critical care unit.

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Recent Stress May Reduce Cancer Therapy Effectiveness

Physical or mental stress one or two days before cancer treatment may reduce the effectiveness of the therapy, researchers have found. In a series of experiments using breast cancer cell cultures, a research team at Ohio State University found that mental and physical stress including rigorous exercise activates a stress-related protein that can trigger a chain reaction that enables cancer cells to survive cancer treatments. Specifically, the investigators discovered that the presence of the heat shock factor-1 (HSF-1) protein could impair the process that kills cancer cells even after their DNA was damaged by radiation or chemotherapy, according to the report published in the Sept. 21 online edition of the journal Molecular Cancer Research.

It may be possible to develop drugs that suppress HSF-1 and use these drugs as a supplement to cancer therapy, the study authors suggested in a university news release. In the meantime, patients should try to avoid physical and mental stress in the days before cancer treatment, they recommended. "One of the known inducers of (HSF-1) is exercise. I am not against exercise, but the timing is critical. It looks like any intense or prolonged physical activity a couple of days before the start of cancer therapy is highly risky, and has potential to reduce the benefits of treatment," lead author Govindasamy Ilangovan, an associate professor of internal medicine, said in the news release.

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No Gender-Based Difference Seen in Anti-HIV Drug Response

Men and women have the same responses to the anti-HIV drugs darunavir and ritonavir, researchers have found. The new study included 429 HIV-positive patients at 65 sites in the United States, Puerto Rico and Canada. HIV is the virus that causes AIDS. The participants were given 600 milligrams of darunavir and 100 mg of ritonavir twice daily. The treatment response rates were 73 percent in women and 73.5 percent in men, the investigators found. Rates of adverse events were also comparable between the sexes. The most common side effects were nausea, diarrhea and rash. The findings are published in the Sept. 21 issue of the journal Annals of Internal Medicine. The Gender, Race and Clinical Experience (GRACE) study was funded by Tibotec Therapeutics, which markets darunavir.

The study authors noted that 32.8 percent of the female participants dropped out before the end of the study, compared with 23.2 percent of the males. This suggests that more needs to be done to retain women in clinical trials. "It is critical that women are involved in clinical trials to evaluate the efficacy and toxicity of new treatments not just for HIV but for all diseases," lead author Dr. Judith Currier, a professor of medicine and chief of the division of infectious diseases at the David Geffen School of Medicine at the University of California, Los Angeles, said in a UCLA news release.

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