Study examines acetaminophen use in pregnancy, child behavioral problems

Bottom Line: Children of women who used the pain reliever acetaminophen (paracetamol) during pregnancy appear to be at higher risk for attention-deficit/hyperactivity disorder (ADHD)-like behavioral problems and hyperkinetic disorders (HKDs, a severe form of ADHD).

Author: Zeyan Liew, M.P.H., of the University of California, Los Angeles, and colleagues.

Background: Acetaminophen is the most commonly used medication for pain and fever during pregnancy. But some recent studies have suggested that acetaminophen has effects on sex and other hormones, which can in turn affect neurodevelopment and cause behavioral dysfunction. Continue reading “Study examines acetaminophen use in pregnancy, child behavioral problems”

Experiencing existential dread? Tylenol may do the trick

Contact: Anna Mikulak amikulak@psychologicalscience.org 202-293-9300 Association for Psychological Science

Thinking about death can cause us to feel a sort of existential angst that isn’t attributable to a specific source. Now, new research suggests that acetaminophen, an over-the-counter pain medication, may help to reduce this existential pain.

The research is published in Psychological Science, a journal of the Association for Psychological Science.

According to lead researcher Daniel Randles and colleagues at the University of British Columbia, the new findings suggest that Tylenol may have more profound psychological effects than previously thought:

“Pain extends beyond tissue damage and hurt feelings, and includes the distress and existential angst we feel when we’re uncertain or have just experienced something surreal. Regardless of the kind of pain, taking Tylenol seems to inhibit the brain signal that says something is wrong.”

Randles and colleagues knew from previous research that when the richness, order, and meaning in life is threatened — with thoughts of death, for instance — people tend to reassert their basic values as a coping mechanism.

The researchers also knew that both physical and social pain — like bumping your head or being ostracized from friends — can be alleviated with acetaminophen. Randles and colleagues speculated that the existentialist suffering we face with thoughts of death might involve similar brain processes. If so, they asked, would it be possible to reduce that suffering with a simple pain medicine?

The researchers had participants take either Tylenol brand acetaminophen or a sugar pill placebo in a double-blind study. One group of participants was asked to write about what would happen to their body after they die, and the control group was asked to write about having dental pain, an unpleasant but not existentially distressing thought.

All the participants were then asked to read an arrest report about a prostitute, and to set the amount for bail.

Just as expected, the control group that wrote about dental pain — who weren’t made to feel an existentialist threat — gave relatively low bail amounts, only about $300. They didn’t feel the need to assert their values.

On the other hand, the participants who wrote about their own death and were given a sugar pill gave over $400 for bail, in line with previous studies. They responded to the threat on life’s meaning and order by affirming their basic values, perhaps as a coping mechanism.

But, the participants in this group who took Tylenol were not nearly as harsh in setting bail. These results suggest that their existential suffering was ‘treated’ by the headache drug.

A second study confirmed these results using video clips. People who watched a surreal video by director David Lynch and took the sugar pill judged a group of rioters following a hockey game most harshly, while those who watched the video and took Tylenol were more lenient.

The study demonstrates that existentialist dread is not limited to thinking about death, but might generalize to any scenario that is confusing or surprising — such as an unsettling movie.

“We’re still taken aback that we’ve found that a drug used primarily to alleviate headaches can also make people numb to the worry of thinking about their deaths, or to the uneasiness of watching a surrealist film,” says Randles.

The researchers believe that these studies may have implications for clinical interventions down the road.

“For people who suffer from chronic anxiety, or are overly sensitive to uncertainty, this work may shed some light on what is happening and how their symptoms could be reduced,” Randles concludes.

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In addition to Randles, co-authors on this research include Steven Heine and Nathan Santos of the University of British Columbia.

This research was supported by a grant and doctoral fellowship from the Social Sciences and Humanities Research Council.

For more information about this study, please contact: Daniel Randles at danielrandles@psych.ubc.ca and Steven Heine at heine@psych.ubc.ca.

The APS journal Psychological Science is the highest ranked empirical journal in psychology. For a copy of the article “The Common Pain of Surrealism and Death: Acetaminophen Reduces Compensatory Affirmation Following Meaning Threats” and access to other Psychological Science research findings, please contact Anna Mikulak at 202-293-9300 or amikulak@psychologicalscience.org.

J&J, FDA leaders take heat for ‘phantom’ recall : Removed Evidence in Secret, of defective infants Tylenol

2010 Event Reposted for Filing

By MATTHEW PERRONE, AP Health Writer Matthew Perrone, Ap Health Writer Thu Sep 30, 5:58 pm ET

WASHINGTON – Johnson & Johnson executives and the Food and Drug Administration both shouldered the blame Thursday for a secret recall in which hired contractors quietly bought up defective painkillers to clear them from store shelves.

J&J Chief Executive William Weldon told House lawmakers the company “made a mistake” in conducting the so-called “phantom recall,” which is one of a string of problems that have drawn congressional scrutiny

In the same committee hearing, the FDA’s deputy commissioner, Dr. Joshua Sharfstein, said his agency should have acted sooner to halt J&J’s plan. At the same time, though, he stressed that regulators were not aware of the deceptive nature of the recall.

Sharfstein and Weldon testified before the House Committee on Oversight and Government Reform, which held its second hearing on J&J’s unprecedented spate of recalls. The largest, involving more than 135 million bottles of infants’ and children’s Tylenol and other medicines, triggered the committee’s investigation.

“We recognize that we need to do better, and we will work hard to restore the public’s trust and faith in Johnson & Johnson,” Weldon told lawmakers.

Democrats and Republicans pressed Weldon on its “phantom” recall involving 88,000 packets of Motrin, which Weldon acknowledged as “not one of our finer moments.”

But lawmakers also pressed the FDA on when and what it knew about the activity. New Brunswick, N.J.-based J&J has repeatedly claimed it alerted the agency’s officials in Puerto Rico, where the defective Motrin was originally manufactured.

Sharfstein said J&J informed the FDA of its plan to repurchase the pills – which did not dissolve correctly – in April 2009.

“From this point, it took until July for the FDA to tell the company that a recall should be conducted,” Sharfstein said in his testimony. “In my opinion that message should have been given sooner.”

But Sharfstein stressed that the FDA did not know J&J had instructed contractors to pose as regular customers while buying the product and to not alert store employees to their activity.

“Based on the documents I reviewed, I don’t see any indication that the FDA was aware of the surreptitious, lying nature of the recall,” he said.

Republican lawmakers criticized a “too cozy” relationship between FDA and J&J employees, citing months-long e-mail exchanges between the two before regulators took action. But Sharfstein said ultimate blame lies with J&J, pointing out that the FDA does not have the authority to order when and how companies conduct recalls.

“I think fundamentally the responsibility is with the company to handle their quality problems in a much different way,” Sharfstein said.

Companies are advised to work with the FDA on recalls, although that isn’t a legal requirement.

Committee Chairman Edolphus Towns, D-N.Y., has introduced a bill that would give the agency the power to order recalls.

The maker of trusted brands like Tylenol and Benadryl, J&J has announced nine recalls of drugs for children and adults since last September with problems ranging from too much active ingredient to tiny shards of metal.

In May, J&J closed its Fort Washington, Pa., facility, the largest manufacturing site for children’s medications. J&J announced Thursday it would begin shipping its grape-flavored Children’s Tylenol next week, the first of its children’s formulas to return to the market.

Weldon said the company plans to invest $100 million across the company to improve facilities, equipment and operations around the world.

Weldon, who has been CEO since 2002, missed the committee’s last hearing because of back surgery.

Testifying beside him Thursday was J&J executive Colleen Goggins, who oversaw the consumer division of the company’s McNeil Healthcare unit during the recalls.

At the May hearing, Goggins told lawmakers she had no knowledge of instructions to contractors involved in the phantom recall to not tell store employees what they were doing. In her testimony Thursday, Goggins acknowledged that the company wrote those instructions.

“Based on what I have learned since May, I believe that McNeil should have handled things differently,” Goggins said.

Goggins will retire in March, Johnson & Johnson announced this month.

Ralph’s Note – If all the product did was not dissolve correctly….Then why the incredible secrecy, and deception? I’m sorry.. First the FDA and J&J admit being dishonest….Then they issue this weak press release. Yes the FDA may not of had the authoity to issue a recall…BUT IT IS THEIR JOB TO AT LEAST INFORM THE PUBLIC.. Now that all the recalled tablets have been secretly REMOVED AS EVIDENCE….How will we ever know the TRUTH. Whatever Tablets remain, need to go to an independent testing facility…. WHY are no lot numbers mentioned in this article? They are probably still sitting in medicine cabinets across the country….

Acetaminophen tied to childhood wheezing and allergies

2010 report posted for filing

NEW YORK (Reuters Health) – A pair of studies suggests that the common painkiller acetaminophen — better known as Tylenol in the U.S. — may be fueling a worldwide increase in asthma.

According to one study out Thursday, acetaminophen could be responsible for as many as four in 10 cases of wheezing and severe asthma in teens.

While no one knows if the drug causes asthma by itself, another report — published along with the first study — shows for the first time that many toddlers took acetaminophen before they developed asthma symptoms such as wheezing.

“We have confirmed that acetaminophen use comes first, so a causal link is increasingly likely,” said Dr. Alemayehu Amberbir, of Addis Ababa University in Ethiopia and the University of Nottingham in the UK.

But large-scale clinical tests are necessary before anyone cleans out their medicine cabinet, stressed Amberbir, whose findings are published in the American Journal of Respiratory and Critical Care Medicine.

His team followed more than 1,000 Ethiopian babies over three years. When the toddlers turned one, the researchers asked the mothers if their babies had breathing problems, and how much acetaminophen they had used.

About eight percent of the kids began to wheeze between ages one and three. Those who had been given acetaminophen during their first year — before they had breathing trouble — had up to seven times the odds of developing wheezing.

That increase held even after adjusting for fever and coughs, which in principle could have triggered both the wheezing and the use of painkillers.

“What we have is further information and a stronger association between the use of acetaminophen and asthma,” said Dr. Dipak Kanabar, who has written guidelines on painkillers, but wasn’t involved in the new studies.

But Kanabar, a consultant pediatrician at Evelina Children’s Hospital in London, cautioned that parents’ recall isn’t always accurate, which could have influenced the findings.

“We have to be careful when we give advice to parents to stress that these studies do not mean that giving acetaminophen will necessarily result in their child developing asthma,” he said.

But if the link turns out to be real, it could have a major impact on public health, according to another report in the American Journal of Respiratory and Critical Care Medicine.

In that study, based on more than 320,000 teens from 50 countries, 11 percent of the children had breathing trouble — only slightly more than the percentage of American children who have asthma.

Those teens who took acetaminophen at least once a month — one third overall, and more than four in 10 Americans — doubled their odds of wheezing.

They were also more likely to have allergic nasal congestion and the skin condition eczema, Dr. Richard W. Beasley, of the Medical Research Institute of New Zealand, and colleagues report.

The researchers estimate that acetaminophen could potentially be responsible for up to four in 10 of all asthma symptoms, including severe ones such as waking up gasping for air once a week or more.

McNeil Consumer Healthcare, the Johnson & Johnson subsidiary that sells Tylenol, said in a comment their product “has over 50 years of clinical history to support its safety and efficacy.”

“The well-documented safety profile for acetaminophen makes it the preferred pain reliever for asthma sufferers,” the company told Reuters Health in an e-mail. The company said there are no gold-standard clinical trials showing “a causal link between acetaminophen and asthma.”

However, Kanabar found in his review of the medical literature that ibuprofen — another painkiller, sometimes sold as Advil — seemed to trigger less wheezing than acetaminophen.

Ibuprofen, however, is not recommended in people with asthma, Kanabar said, and that most doctors favor Tylenol.

Aspirin, another common painkiller, is generally discouraged in children because it can cause short-term breathing problems and other rare side effects.

According to Kanabar, dropping painkillers entirely is probably a bad idea, and might cause a child to feel worse and drink less liquid, which could slow recovery.

So which painkiller should a parent choose if their child has a headache or a fever — Tylenol or ibuprofen?

At this point, said Kanabar, “you could go for either.”

SOURCE: http://link.reuters.com/sej74n American Journal of Respiratory and Critical Care Medicine, online

Aspirin, Tylenol May Decrease Effectiveness of Vaccines: “if you block COX-1, you might be decreasing the amount of antibodies your body is producing”

2009 study posted for filing

Contact: Kelsey Jackson JacksonKN@missouri.edu 573-882-8353 University of Missouri-Columbia

Aspirin, tylenol may decrease effectiveness of vaccines

Mizzou scientists discover aspirin and Tylenol block enzymes that could inhibit vaccines

COLUMBIA, Mo. – With flu season in full swing and the threat of H1N1 looming, demand for vaccines is at an all-time high. Although those vaccines are expected to be effective, University of Missouri researchers have found further evidence that some over-the-counter drugs, such as aspirin and Tylenol, that inhibit certain enzymes could impact the effectiveness of vaccines.

“If you’re taking aspirin regularly, which many people do for cardiovascular treatment, or acetaminophen (Tylenol) for pain and fever and get a flu shot, there is a good chance that you won’t have a good antibody response,” said Charles Brown, associate professor of veterinary pathobiology in the MU College of Veterinary Medicine. “These drugs block the enzyme COX-1, which works in tissues throughout the body. We have found that if you block COX-1, you might be decreasing the amount of antibodies your body is producing, and you need high amounts of antibodies to be protected.”

COX enzymes play important roles in the regulation of the immune system. The role of these enzymes is not yet understood completely, and medications that inhibit them may have adverse side effects. Recent research has discovered that drugs that inhibit COX enzymes, such as COX-2, have an impact on the effectiveness of vaccines. Brown’s research indicates that inhibiting COX-1, which is present in tissues throughout the body, such as the brain or kidneys, could also impact vaccines’ effectiveness.

These MU researchers also are studying the regulation of inflammation and how that leads to the development or prevention of disease. Many diseases, such as arthritis, cardiovascular disease and diabetes, are all chronic inflammatory diseases. Contrary to previous beliefs, inflammation is generally a good thing that helps protect individuals from infection. Many of the non-steroidal drugs that treat inflammatory conditions reduce antibody responses, which are necessary for treating infections.

“So far, we’ve tested this on an animal model and have found that these non-steroidal drugs do inhibit vaccines, but the next step is to test it on humans,” Brown said. “If our results show that COX-1 inhibitors affect vaccines, the takeaway might be to not take drugs, such as aspirin, Tylenol and ibuprofen, for a couple weeks before and after you get a vaccine.”

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Brown’s research, “Cycloozygenase-1 Orchestrates Germinal Center Formation and Antibody Class-Switch via Regulation of IL-17,” has been published in The Journal of Immunology.

Commonly used medications may produce cognitive impairment in older adults:

2009 study posted for filing

Contact: Cindy Fox Aisen
caisen@iupui.edu
317-274-7722
Indiana University

Drugs, such as diphenhydramine, which have an anticholinergic effect, are important medical therapies available by prescription and also are sold over the counter under various brand names such as Benadryl®, Dramamine®, Excederin PM®, Nytol®, Sominex®, Tylenol PM®, and Unisom®. Older adults most commonly use drugs with anticholinergic effects as sleep aids.INDIANAPOLIS – Many drugs commonly prescribed to older adults for a variety of common medical conditions including allergies, hypertension, asthma, and cardiovascular disease appear to negatively affect the aging brain causing immediate but possibly reversible cognitive impairment, including delirium, in older adults according to a clinical review now available online in the Journal of Clinical Interventions in Aging, a peer reviewed, open access publication.

While it is known that these medications do have an effect on the brain and in the case of sleeping pills, are prescribed to act on the brain, the study authors suggest the amount of cognitive impairment caused by the drugs in older adults is not well recognized.

“The public, physicians, and even the Food and Drug Administration, need to be made aware of the role of these common medications, and others with anticholinergic effects, in causing cognitive impairment. Patients should write down and tell their doctor which over-the-counter drugs they are taking. Doctors, who often think of these medications simply as antihistamines, antidepressants, antihypertensives, sleep aids or even itching remedies, need to recognize their systemic anticholinergic properties and the fact that they appear to impact brain health negatively. Doing so, and prescribing alternative medications, should improve both the health and quality of life of older adults,” said senior study author Malaz Boustani, M.D., Indiana University School of Medicine associate professor of medicine, Regenstrief Institute investigator, and research scientist with the IU Center for Aging Research.

Dr. Boustani and colleagues conducted a systematic evidence-based analysis of 27 peer reviewed studies of the relationship of anticholinergic effect and brain function as well as investigating anecdotal information. They found a strong link between anticholinergic effect and cognitive impairment in older adults.

“One of the goals of our work is to encourage the Food and Drug Administration to expand its safety evaluation process from looking only at the heart, kidney and liver effects of these drugs to include effects of a drug on the most precious organ in human beings, our brain,” Dr. Boustani said.

“Many medications used for several common disease states have anticholinergic effects that are often unrecognized by prescribers” said Wishard Health Services pharmacist, Noll Campbell, Pharm.D., first author of the study, noting that these drugs are among the most frequently purchased over the counter products. “In fact, 50 percent of the older adult population use a medication with some degree of anticholinergic effect each day.”

“Our main message is that older adults and their physicians should have conversations about the benefits and harms of these drugs in relation to brain health. As the number of older adults suffering from both cognitive impairment and multiple chronic conditions increases, it is very important to recognize the negative impact of certain medications on the aging brain,” said Dr. Boustani.

The brain pharmacoepidemiology group of the IU Center for Aging Research currently is conducting a study of 4,000 older adults to determine if the long term use of medications with anticholinergic effects is linked to the irreversible development of cognitive impairment such as Alzheimer disease.

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Authors of the JCIA study are Noll Campbell, Pharm.D., Wishard Health Services; Malaz Boustani, M.D., MPH; Tony Limbil, M.D., MPH, of University of Illinois; Carol Ott, Pharm.D. of Wishard and Purdue University; Chris Fox, MRCPsych and Ian Maidment, B.Pharm., of Kent Institute of Medicine and Health Sciences University of Kent and Medway NHS Trust, United Kingdom; Cathy C. Schubert, M.D. of the IU School of Medicine; Stephanie Munger, B.S., of Regenstrief and IUCAR; Donna Fick, R.N., Ph.D., of Pennsylvania State University; David Miller, M.D., of the IU School of Medicine and Rajesh Gulati, M.D., of IU Medical Group – Primary Care.

The study was funded by the John A. Hartford Foundation, the Atlantic Philanthropies, the Starr Foundation, and the National Institute on Aging