Aggression

Common dietary supplement found to reduce aggression by 30%

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A common dietary supplement reduces aggression by 30%

A common dietary supplement reduces aggression by 30%

Fish oil supplements containing omega-3 have long been touted as good for heart health. A new study has found they also reduce aggression. Researchers say the safe, common supplements should be used everywhere from the playground to the prison system.

Overt acts of aggression include verbal and physical violence and bullying. Then, there are covert signs like vandalism and property damage, fire-setting, and theft. Both can negatively affect relationships and have legal consequences. It goes without saying that, on many levels, society would be better off if aggressive behaviors were reduced. A new study may have discovered a way of doing that.

The study by researchers from the University of Pennsylvania (Penn) found that commonplace omega-3 supplements reduced aggression, regardless of age or gender.

“I think the time has come to implement omega-3 supplementation to reduce aggression, irrespective of whether the setting is the community, the clinic, or the criminal justice system,” said Adrian Raine, a Penn neurocriminologist and the lead and corresponding author of the study. “Omega-3 is not a magic bullet that is going to solve the problem of violence in society. But can it help? Based on these findings, we firmly believe it can, and we should start to act on the new knowledge we have.

Omega-3 has enjoyed a strange association with violent behavior for a while. Back in 2001, Dr Joseph Hibbeln, a senior clinical investigator at the US National Institutes of Health (NIH), published a study finding a correlation between the consumption of high amounts of fish (a rich source of omega-3) and lower homicide rates. The following year, the University of Oxford in the UK led a study where British prisoners were given nutritional supplements that included vitamins, minerals and essential fatty acids. The researchers found that prisoners given supplements were less violent and antisocial.

In addition to examining the effect of omega-3 supplements on aggression, the researchers in the current study particularly wanted to ascertain whether omega-3 was effective for all forms of aggression. In psychology, a distinction is made between ‘reactive’ aggression, an in-the-moment response to a perceived threat or provocation, and ‘proactive’ aggression, which requires planning.

The researchers conducted a meta-analysis of 29 randomized controlled trials that explicitly measured aggression in people who’d been given omega-3 supplements. They specifically focused on aggressive behavior and not broader traits like anger, which is viewed more as a feeling or emotion, and hostility, which is more of an attitude. Studies where additional nutritional supplements, such as calcium and vitamin D, were included, but the researchers examined them as a potential moderator.

A modest short-term effect linked to omega-3 supplementation, which the researchers say equates to a 30% reduction in aggression, was seen across age, gender, baseline diagnosis, treatment duration and dosage. Notably, omega-3 was found to reduce both reactive and proactive aggression. The researchers were limited to short-term data because only one out of the 19 laboratories conducting the studies followed up with participants after supplementation ended

The researchers explain how they think omega-3 exerts its effects. Previous studies have pointed to aggressive and violent behavior having a cognitive and neurochemical basis. And, omega-3 is known to play a critical role in brain structure and function, including regulating neurotransmitters and gene expression, and reduces brain inflammation.

“As such, given the undeniable fact that omega-3 is pervasively involved in multiple facets of neuronal biology, it is reasonable to believe that omega-3 supplementation could play a causal role in reducing aggression by upregulating brain mechanisms that may be dysfunctional in … individuals, given the assumption that there is, in part, a neurobiological basis to aggression,” said the researchers.

Further studies are needed to assess the long-term effectiveness of omega-3 supplementation on reducing aggression. Other research avenues would be using MRI scans to determine whether omega-3 enhances brain functioning and examining whether genetics affects omega-3 treatment. In the meantime, the researchers say there is little harm in people, including children, taking this widely available, safe and inexpensive dietary supplement.

“At the very least, parents seeking treatment for an aggressive child should know that in addition to any other treatment that their child receives, an extra portion or two of fish each week could also help,” Raine said.

And the researchers say omega-3 should be used in conjunction with existing psychological and psychiatric treatments.

“[W]e would argue that omega-3 supplementation should be considered as an adjunct to other interventions, whether they be psychological (e.g. CBT [cognitive behavioral therapy]) or pharmacological (e.g. [the antipsychotic drug] risperidone) in nature, and that caregivers are informed of the potential benefits of omega-3 supplementation,” the researchers said.

Montelukast’s Underrecognized Adverse Drug Events

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The US Food and Drug Administration (FDA) first alerted healthcare professionals (HCPs) about a possible association between the use of leukotriene inhibitors and neuropsychiatric events in 2008 and added information to product labels in 2009. The reported events included agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. While the precaution was extended to all agents in this class (montelukast [Singulair®], zafirlukast [Accolate®], and zileuton [Zyflo®]), particular concern has been raised about montelukast due to its widespread use in both adult and pediatric patients for multiple indications. Montelukast is approved for the chronic treatment of asthma, acute prevention of exercise-induced bronchial constriction, and relief of both perennial and seasonal allergic rhinitis symptoms. Singulair is approved in adults and children 6 months of age and older. Continued concerns about suicidality and neuropsychiatric events with montelukast were again raised at a recent FDA Pediatric Advisory Committee (PAC) meeting in September 2014. Medscape spoke with Sally Seymour, MD, and Erika Torjusen, MD, MHS, both at the Center for Drug Evaluation and Research in the Division of Pulmonary, Allergy, and Rheumatology at the FDA, about the advisory committee meeting, concerns with these agents, and the implications for HCPs.

Medscape: Can you briefly review the concerns presented at the advisory committee meeting about these agents?

Dr Seymour: On September 23, 2014, montelukast [Singulair] was discussed at the PAC meeting as part of a routine pediatric safety review conducted after a drug has new pediatric labeling.

During the open public hearing, a parent who represented numerous groups wanted to raise awareness of the potential for neuropsychiatric events with montelukast. The speaker stated that, despite the FDA’s communication efforts and information in the product label, many physicians are not aware or do not communicate the risk for neuropsychiatric events to patients.

As part of the discussion, the committee reviewed the current montelukast labeling regarding the risk for neuropsychiatric events. Members wanted HCPs to be cognizant of the association with neuropsychiatric events and consider discontinuing montelukast if they occur. The PAC recommended a communication directed at HCPs to raise awareness of the association of neuropsychiatric events. This Medscape interview is a result of the committee’s recommendations.

Medscape: In addition, the committee heard about the available objective data regarding montelukast and neuropsychiatric events. Could you summarize those data? What do we know about these adverse events, what they look like, how acutely they occur, and the populations in which they occur?

Dr Seymour: At the PAC meeting, we briefly summarized the FDA’s previous review of this safety issue. In 2008-2009, we reviewed available data (postmarketing and clinical trial data) to evaluate the risk for neuropsychiatric events with leukotriene modifiers: montelukast, zileuton, and zafirlukast. During this review of spontaneous postmarketing reports, we noted a variety of neurologic or psychiatric adverse events associated with use of these products. Reports included: agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. Some of these reports appeared to be consistent with a drug-induced effect. Events were noted in both adults and children, and the onset of events varied.

Based upon these data, the FDA required the manufacturers to add information to the product labels. All of these labels now have a warning/precaution about the risk for neuropsychiatric events.

Medscape: This was a pediatric advisory committee meeting. Were all of these events reported in children, or are adults also experiencing these adverse events?

Dr Seymour: We have reports of children and adults experiencing these types of events. We especially want to reach out to HCPs taking care of children because montelukast is approved for children down to 6 months of age, and detecting these events in children may be more challenging. Small children can’t report side effects, and young children or teenagers may experience changes in behavior or mood that can be mistakenly attributed to a normal phase of development. Therefore, parents and practitioners need an increased level of awareness about the risks of montelukast in these age groups.

Medscape: Are these adverse events reversible with drug discontinuation, and is there a time frame in which they are likely to occur?

Dr Torjusen: The most common adverse events are typically not serious. These events are generally reversible with cessation of therapy. In terms of timing, we have reports following initiation of montelukast and after chronic use.

Medscape: You noted that the committee made a determination that more outreach and strengthening of prescriber warnings was warranted. Were there any other committee recommendations? For example, will there be any requirement to manufacturers to conduct any further studies?

Dr Torjusen: Based on the testimony provided during the open public hearing, the PAC recommended potential strategies for increasing awareness of the neuropsychiatric events that may occur with montelukast. Possibilities raised by the committee included labeling changes, education of providers, and consideration for further studies. The PAC recommendations can be found on our website.

Dr Seymour: When the FDA completed its initial review in 2009 and required the companies to update the product labeling, we did not require clinical trials to further evaluate this issue. Because this is a known safety issue, the FDA does not think that changes to the prescriber information or clinical studies are warranted at this time. The PAC noted that the patient labeling was clear.

Medscape: Given that this is a class-wide concern, should all leukotriene inhibitors be avoided in patients who experience these symptoms in response to one agent? Or is it worth a clinician trying another drug in the same class if it was felt it was really indicated?

Dr Torjusen: Based on the data available, this does appear to be a class effect and is the reason the labeling change was applied to all of the drugs in the class of leukotriene inhibitors. Therefore, if a patient experiences neuropsychiatric symptoms while on one leukotriene inhibitor, we would recommend that they avoid other drugs in the class.

Medscape: Why do you think this now 5-year-old safety issue is not well known by prescribers?

Dr Torjusen: That is a good question. It is possible that awareness of the association between montelukast and neuropsychiatric events has faded. HCPs are inundated with new products and new safety information, and keeping up with all of this can be a challenge. In addition, the types of events experienced are highly variable. Detecting these events in children and young adults can be particularly challenging. Young children may be less able to articulate these experiences, and parents may unknowingly attribute symptoms to be part of developmental changes. Therefore, reminders of important safety concerns may be necessary at times for both patients and providers.

Medscape: What are the key take-home messages for clinicians who are prescribing this class of drugs?

Dr Torjusen: The key take-home message is for HCPs to be aware of the risk for neuropsychiatric events with the use of montelukast. Providers should inform their patients and families that these types of side effects are a possibility with these medications, and they should follow up with their patients after initiation of therapy.

Patients should also notify their HCPs if side effects occur, and HCPs should consider discontinuing therapy if patients develop neuropsychiatric symptoms.

Medscape: Are there resources for patient education that clinicians can and should use?

Dr Torjusen: Certainly, clinicians can always refer to the product label for montelukast [Singulair], which provides safety information for the product. In addition, the patient prescribing information provides useful information on the product, including side effects.

Information about the FDA’s review of the safety issue can be found on the FDA website.

Serious adverse events should also be reported to the FDA MedWatch or by calling the FDA at 1-800-FDA-1088. Patients and HCPs who want more information about specific products can go to the FDA website or contact the FDA [1-888-INFO-FDA].

Soda Linked to Aggression, Attention Problems, and Social Withdrawal in Young Children.

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Soda has already been blamed for making kids obese. New research blames the sugary drinks for behavioral problems in children too.

Analyzing data from 2,929 families, researchers linked soda consumption to aggression, attention problems and social withdrawal in 5-year-olds. They published their findings in the Journal of Pediatrics on Friday.

Although earlier studies have shown an association between soft-drink consumption and aggression in teens, none had investigated whether a similar relationship existed in younger children.

To that end, Columbia University epidemiologist Shakira Suglia and her colleagues examined data from the Fragile Families and Child Wellbeing Study, which followed 2,929 mother-child pairs in 20 large U.S. cities from the time the children were born. The study, run by Columbia and Princeton University, collected information through surveys the mothers completed periodically over several years.

In one survey, mothers answered questions about behavior problems in their children. They also reported how much soda their kids drank on a typical day.

Suglia and her colleagues found that even at the young age of 5, 43% of the kids consumed at least one serving of soda per day, and 4% drank four servings or more.

The more soda kids drank, the more likely their mothers were to report that the kids had problems with aggression, withdrawal and staying focused on a task. For instance, children who downed four or more servings of soda per day were more than twice as likely to destroy others’ belongings, get into fights and physically attack people, compared with kids who didn’t drink soda at all.

Source: RealFarmacy.com