Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: An integrated analysis of 15 clinical trials

Atomoxetine is FDA indicated to treat attention deficit hyperactivity disorder (ADHD), and is very commonly prescribed. Because it is a common drug, it is notably important to study the potential for adverse effects, especially serious ones. This study ignores effectiveness and focuses solely on safety.

This study confirmed some of the most well known side effects such as nausea, dry mouth, decreased appetite, insomnia, marginal increases in heart rate and blood pressure, and erectile dysfunction. No side effects seen in this study were previously unknown to occur with atomoxetine. None of the subjects experienced any serious adverse effects, including suicidal thoughts.

The results of this study confirm that atomoxetine is a safe treatment option for ADHD. This study did not examine the effectiveness of the drug in treating ADHD, which often can be highly subjective when comparing ADHD to other disease states. Therefore, the main idea to be elucidated from the results of this study is that atomoxetine is a safe therapy option. If the patient feels that it is working well for them, they can continue to use it without fearing any serious adverse effects, and if other treatment options are not working, they can confidently switch to atomoxetine.

Camporeale A, Porsdal V, De Bruyckere K, et al. Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials. J Psychopharmacol. 2015: 29(1): 3-14.  


Effects of Prenatal Acetaminophen Exposure and Risk of Attention Deficit/Hyperactivity Disorder in Children

Acetaminophen has always been one of the most commonly used medications during pregnancy. It is reported that 65%-70% of women use acetaminophen at least once during their pregnancy due to the safety associated with it. In 2015, the FDA stated that there is a possible risk of ADHD developing in children who were exposed to acetaminophen prenatally.

After reviewing several previous studies, it was found that no certain relationship can be identified between prenatal exposure to acetaminophen and the development of ADHD. This is partly caused by the fact that diagnosing methods of ADHD have also changed. There are new medications now that are extended release to treat ADHD. These factors affect the number of children being reported to have ADHD, typically increasing it. It is not clear if there is actually an increase in the number of children with ADHD or if it is just being correctly diagnosed now.

The article explains that pharmacists should continue to recommend the lowest effective dose of acetaminophen. They should also make an effort to educate other health care providers and the expecting mothers of the importance of using acetaminophen properly. Other than these suggestions, what else could pharmacists due to prevent any additional side effects of common medications to pregnant women?

Hoover RM, Hayes AG, Erramouspe J. Association Between Prenatal Acetaminophen Exposure and Future Risk of Attention Deficit/Hyperactivity Disorder in Children. Ann Pharmacother. 2015: 49(12); 1357-1361.

Impact of attention-deficit hyperactivity disorder on school performance: what are the effects of medication?

ADHD is a disorder that can detrimentally affect a student’s performance in school and extracurricular activities. ADHD medications are highly regulated medications because they have a high abuse/theft rate because students who don’t have ADHD take them in attempts to approve their academic performance. This study looks at how much these medications actually improve quantifiable performance of students with ADHD. This study looked at academic performance (GPA, work completed) and academic skills (achievement and cognitive tests), and academic enablers (study skills, motivation) of school-age children to determine how much these stimulants improve students’ overall performance, synthesizing data from many long- and short-term studies. The results found that CNS stimulant use improved teacher perceptions of students’ classroom behavior the most, reducing disruptive behavior and increasing focus on classroom activities. It was also observed that use of stimulants increase students’ productivity, which could possibly lead to a long-term increase in GPA. The efficacy of these medications is mainly reduced by adherence, and can also be affected by the learning environment. Optimizing the effects of these medications is achieved by constant reassessment of efficacy and patient adherence.

I found this study really interesting because I know many people who have really struggled with academic performance because of ADHD, and how much being properly medicated helped their performances. As prescription of ADHD medications becomes increasing more prevalent, it is important as pharmacists to make sure that the people who actually need these types of medications are the one taking them, and that they are properly counseled in order to achieve maximum efficacy.

Baweja R, Mattison RE, Waxmonsky JG. Impact of attention-deficit hyperactivity disorder on school performance: what are the effects of medication? Paediatr Drugs. 2015; 17:459-477.

Nonmedical Usage of Prescription Stimulants

This study was aimed at examining the trends regarding the current usage of stimulants, nonmedical use of stimulants, and emergency department visits involving prescription stimulants in the United States. The most commonly abused stimulants are those that are commonly prescribed for attention-deficit/hyperactivity disorder (ADHD). The term prescription stimulant refers mainly to schedule II substances such as methylphenidates and dextroamphetamine-amphetamines. In 2011, 1.1 million American’s admitted to using these prescription stimulants nonmedically in the past year. This study looked at data collected from three national surveys issued between 2006 and 2011. They found that in adolescents, treatment visits for dextroamphetamine-amphetamine and methylphenidate decreased over time, as did the nonmedical usage of these stimulants. However in adults, both nonmedical use and emergency department visits involving stimulants increased. Both age groups cited a friend of relative with a prescription as the source for the stimulants they obtained. The study found no correlation between increased prescribing and increased nonmedical use. Although nonmedical usage rose for adults, prescription trends stayed about the same. This highlights that we have an urgent need for public health campaigns targeted at sharing prescription medication for nonmedical use. One study found that 61.7% of college students diagnosed with ADHD have at one time or another diverted their medication. It also found that nonmedical stimulant users had very limited knowledge of the side effects of these drugs. This tells me that we need to be educating college students on the risks associated with stimulants including the side effects, and how they can affect a person not actually diagnosed with ADHD. I feel that this is a topic that students like ourselves can educate our friends and peers on the dangers of misusing prescription drugs.


Chen L, Crum RM, Strain EC, et al. Prescriptions, nonmedical use, and emergency department visits involving prescription stimulants. J Clin Psychiatry. (published 16 February 2016)

Methylphenidate for ADHD in children and adolescents

Methylphenidate is often prescribed to children and adolescents for the treatment of ADHD, or attention-deficit/hyperactivity disorder, however, there is no known comprehensive systematic review on the harms and benefits of administering the medication to the young patients.  Previous reviews have bias or contain flaws, thus, this research study agrees to use guidelines following the Cochrane Handbook and PRISMA guidelines.  Full texts of randomized clinical trials that compared methylphenidate with or without a placebo in the age range of about 3 to 18 years were selected.  Pharmaceutical companies were contacted for additional information.  Primary outcomes included serious adverse effects and symptoms of ADHD, while secondary outcomes included non-serious adverse effects.  No patients were involved in the study.  The data was extracted from the trials by reviewers and the authors were contacted for more information.  The dose of methylphenidate, design of trials, bias, sex of participants, type of ADHD, and other factors were analyzed in the clinical trials.  Concerning quality of evidence, the potential levels of bias associated with the trials evaluated.

Out of 14,431 records, 761 of the publications were included in this review.  In the results, a high possibility of bias was found in most trials due to the passion, failure of full coverage blinding, choosy in reporting data, etc.  Thus, although many of the outcomes suggest that methylphenidate shows benefits, this cannot be deemed as a true conclusion due to the high risk of bias associated with many trials.  Conclusions show that symptoms associated with methylphenidate may be improved and may not cause increase serious adverse effects.  However, methylphenidate may result in a high risk of non-serious adverse effects, such as decreased appetite and sleep problems.

I hope to see a future trial that has little risk of bias, which accounts for all the adverse effects that occur as a result.  This could help with children and adolescent patients who are currently diagnosed with ADHD and could potentially unveil that they are not receiving the benefits that they believe they are supposed to receive.

BMJ. 2015 ; 351(5203): .