Tag Archives: daytrana

Quick Hits: FDA Approves New Antibiotic, ADHD Med, and Opioid Use in Depressed Patients

The FDA has approved Baxdela (delafloxacin), a fluoroquinolone antibiotic that is used to treat acute bacterial skin and skin structure infections (ABSSSI). The drug is available as a tablet or intravenous injection. Labeling for the drug includes a “black box” warning due to serious adverse and potentially irreversible reactions that have been associated with fluoroquinolones, such as tendinitis and tendon rupture, peripheral neuropathy and central nervous system effects. In trials, the most common adverse reactions in patients observed were nausea, diarrhea, headache, elevations of the enzyme transaminase, which can indicate liver damage, and vomiting. Posted June 19, 2017. Via Melinta Therapeutics.

A new once-daily treatment for attention deficit/hyperactivity disorder (ADHD) has won FDA approval. Mydayis, a stimulant for patients 13 years and older, contains the same active ingredients as Adderall (amphetamine/dextroamphetamine), but lasts for up to 16 hours compared to up to 6 for Adderall and 12 for Adderall XR. Adderall and Adderall XR are both available as a generic. Like other stimulant medications, such as methylphenidate (Ritalin, Concerta, Daytrana), Mydayis has a “black box” warning because it has a high chance for abuse and can cause physical and psychological dependence. Posted June 20, 2017. Via Shire.

Patients with low back pain who also suffer from depression are more likely to be given opioids that are prescribed at higher doses. This is problematic, since patients with depression are at a higher risk of misuse and overdose of opioids. Researchers examined data on opioid prescriptions from 2004-2009 and found that those with low back pain who also had depression were twice as likely to be prescribed an opioid than those without depression. And over a year, they typically got more than twice the usual dose, according to the study published in the journal Pain Reports. The authors noted more study is needed to determine the risks and benefits of prescribing such powerful painkillers to those who are depressed. Posted June 20, 2017. Via University of Rochester Medical Center.

ADHD and Homework: Skip the Stimulants in Favor of Behavioral Interventions

Behavioral interventions are better than stimulant medication in helping children with ADHD (attention deficit/hyperactivity disorder) with completing homework.

Researchers enrolled 75 children with ADHD who took part in an 8-week summer school session. The children ranged in age from 5 to 12 years old. The students were given either a long-acting stimulant or a behavioral intervention that included both report cards for kids and training for parents on how to help their kids with homework.

In the stimulant group, physicians took about 2 weeks to determine the correct drug dose to give them. After that, for another 3 weeks, those students were given either a stimulant or placebo. For the last 3 weeks, those who were on a stimulant switched to a placebo, and vice versa. The stimulant given was methylphenidate, which is known under the brand names Ritalin, Daytrana and Concerta.

In the behavioral therapy group, students took part in six 2-hour group sessions for the first 2 weeks, and then individual sessions lasting 30 minutes over the following 2 weeks.

Children who received behavioral treatment were able to finish between 10% and 13% more homework and assignments, and the work was also 8% more accurate than that of the children who received a stimulant only, the researchers reported in the Journal of Consulting and Clinical Psychology. Medication had no significant impact on homework performance.

The authors note this translates to children who received behavioral treatment getting an average grade of C compared to an average grade of F for those who didn’t get the intervention.

Treating ADHD Without Drugs

I have spent many years using an integrative approach to treat children with ADHD, usually using medication only when non-pharmaceutical interventions are not successful. This begs the question: Why not just use medications, since they have been shown to be effective? This could be the topic of an article in itself but, here’s my response, briefly.

The research evidence so far supports only the fact that stimulant medications work well over the short term, and only about 70% of the time. The long-term research we have so far — and there is very little of it — fails to show long-term benefit. There are significant side-effects in many children, some of which are serious. Also, we do not know the long-term effects of chronic stimulant treatment on the developing brain.

Given all of the above, what are effective non-pharmaceutical treatment for ADHD?

Nutrition

There is ample evidence that nutrition plays a significant role in the presence and severity of ADHD. First, repeated studies, the latest from The Lancet in 2011, show that a significant proportion of children with ADHD respond positively to an elimination diet. For reasons we do not understand, foods significantly affect the behavior of some children with ADHD.

This is not based on true IgE (immunoglobulin E) allergies, which are usually absent. The most common offending foods are gluten and dairy, but other foods may be implicated. I have found this nutritional approach successful in about 33-50% of my patients.

Artificial colors and other additives have been shown to increase hyperactivity and decrease attention even in normal children.

Second, basic nutrition is important. Eating foods loaded with sugar, refined carbohydrates and fat can lead to a cycle of blood sugar spikes and crashes which result in increased hyperactivity and decreased attention. Consider the impact of eating a Pop-Tart or waffles and syrup for breakfast.

Artificial colors and other additives have been shown to increase hyperactivity and decrease attention even in normal children. In Europe, the evidence is considered strong enough that a warning label is attached to foods with certain artificial colors.

Omega-3 Fatty Acids

Research has shown that children with ADHD have decreased blood levels of Omega-3s. The reason for this is not known. There have been a number of studies examining whether Omega-3 supplements could improve ADHD symptoms. Most of these have shown positive results, some have not.

However, a 2011 meta-analysis came to the conclusion that Omega-3 fatty acid treatment was “modestly effective” in the treatment of ADHD — in fact, 40% as effective as stimulants. This appears to me to be a remarkably positive result for a supplement with minimal side effects and other health benefits.

Iron and Zinc

If you are working with a doctor to discover if your child has ADHD, you should check that the doctor tests for iron and zinc levels. The role of iron in ADHD appears to be highly significant. A number of studies have shown that ADHD children have low ferritin levels compared to non-ADHD children and functional MRI research has shown abnormal brain iron metabolism in ADHD children. One study showed positive effects in treating ADHD children whose ferritin was less than 30 ng/mL with iron supplements. Of note, these children have low ferritin, but are generally not anemic.

Zinc has also been studied in children with ADHD. Results have varied but a few studies in zinc deficient children have shown positive results. One interesting study showed that the addition of zinc decreased necessary stimulant dose by 37%. I always check ferritin and zinc levels in children with ADHD.

Sleep

Sleep is very important in ADHD. Sleep apnea must always be ruled out, and length and quality of sleep are important. Many children do not get enough sleep in our society, with corresponding deficits in performance.

Herbal Treatments

A 2014 randomized trial showed that the herb ginkgo biloba, traditionally used for memory and concentration, significantly improved ADHD symptoms in children already using methylphenidate. Another study of ginkgo alone was negative, but 2 open label studies were positive. More research is needed but it is a generally safe herb with few side effects.

Parenting

I believe parenting has a major impact on the severity of ADHD symptoms. Many parents have a difficult time with the frustrating, unpredictable and often oppositional nature of their children’s behavior. Parents can be caught in a cycle of anger and negativity which as a very deleterious impact on a child’s performance. Referral to a mental health practitioner for parenting help and support is an important part of the treatment plan in many of my patients.

Other Lifestyle Factors

There is preliminary, but increasing evidence that lifestyle factors such as exercise, yoga, mindfulness meditation and time in nature can have highly positive effects for ADHD children.

EEG Neurofeedback and Computer Based Learning

Most children with ADHD have abnormal brain wave patterns, with a decreased ratio of beta to theta waves. A diagnostic test measuring this ratio, NEBA, was licensed by the FDA last year. More importantly, children can change these brain wave patterns using this biofeedback technique. The research supporting this is strong.

Unfortunately, it is, at this point, too expensive for the average family and not covered by insurance. However, I believe the development of new home based computer learning programs will have a major role for ADHD treatment in the future.

Other “Alternative” Modalities

Modalities like traditional Chinese medicine, homeopathy and various types of energy medicine can be employed, but have little research support at this point.

In summary, non-pharmaceutical treatment of ADHD has a reasonable evidence base and I have found it to be effective in many children. The particular interventions chosen would depend on the individual child and family, taking into account their interests and resources. This approach can have very beneficial aspects, whether or not a psychostimulant is ultimately judged to be necessary.

Irregular Heartbeat Risk Associated with Common ADHD Med

Children who take a common drug to treat attention-deficit/hyperactivity disorder may be at an increased risk for developing an irregular heartbeat.

The drug, methylphenidate, is the active ingredient in Concerta, Daytrana and Ritalin. Children who took methylphenidate had a 61% increased risk of arrhythmias within the first 2 months of starting treatment, researchers reported in the BMJ.

The risk of arrhythmia was highest in the first 3 days of use. It was also more likely in children with existing congenital heart disease.

Although the absolute risk is relatively low, the researchers noted that the benefits of the medication “should be carefully weighed against the potential cardiovascular risks of these drugs in children and adolescents.”

In the study, investigators looked at data from a South Korean health database on 114,647 children and young people aged 17 and younger who were newly treated with methylphenidate at some point from 2008 through 2011. During that time, 1,224 cardiac events were reported. These included arrhythmias, high blood pressure, heart attacks, ischemic stroke and heart failure.

Although there was an elevated risk of arrhythmias in taking the drug, no increased risk was observed for hypertension, ischemic stroke or heart failure.

Although the authors conceded the study was observational in nature, they nonetheless argue that “methylphenidate exposure in children and young people with diagnosis of ADHD is associated with arrhythmia and potentially with myocardial infarction in specific time periods of use. With the increased use of drugs for ADHD globally, the benefits of methylphenidate should be carefully weighed against the potential cardiovascular risks of these drugs in children and adolescents.”