The FDA recently issued a warning that ADHD medications containing methylphenidate may cause priapism, a painful and long-lasting erection. The FDA concluded the association between these mediations and priapism based on reports to the FDA Adverse Event Reporting System (FAERS) and the biomedical literature.
Medications included in the warning were methylphenidate (Daytrana); methylphenidate hydrochloride (Concerta, Metadate CD, Metadate ER, Methylin, Methylin ER, Quillivant XR, Ritalin, Ritalin LA, Ritalin SR); and dexmethylphenidate hydrochloride (Focalin, Focalin XR).
In the FDA’s review, released in December 2013, the average age of those experiencing this side effect was 12.5 years old. Most of the cases of priapism occurred during some sort of change in dosing—including during an increase, temporary decrease, or discontinuation of the medication.
Despite the safety warning, this side effect is rare. According to the FDA, approximately 2.9 million males were prescribed methylphenidate or dexmethylphenidate in 2012. There were only 15 reported cases of priapism related to methylphenidate in the 15 year period between 1997 and 2012. However, it should be noted that the FAERS is a voluntary reporting system, so these numbers may not represent the actual prevalence of this side effect.
This warning is not intended to discourage prescribers from using these medications or to encourage them to switch meds for this reason. In fact, the FDA safety release points out that the non-stimulant atomoxetine (Strattera) also can cause priapism; in fact rates of the side effect are higher with that medication.
In the warning, the FDA wrote, “younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs. All male patients and their caregivers should be taught the signs and symptoms of priapism and the importance of seeking immediate medical treatment if it occurs.”
When discussing side effects with patients taking any medications that may cause priapism, it’s worthwhile to explain what it is and that any erection lasting more than four hours—with or without sexual activity—is not normal and requires immediate medical attention.
Exposure Therapy Best for Some Girls’ PTSD
A recent study found that the same type of therapy that has been proven best for PTSD seen in soldiers returning from war can be effective in treating PTSD in adolescent girls who have been victims of sexual violence.
A single-blind, randomized clinical trial comparing prolonged exposure (PE) therapy to supportive counseling in girls age 13 to 18 found the former to be superior in treating PTSD.
In the study, PE was administered in 14, 60- to 90-minute sessions. The main outcome measure was PTSD symptoms, which were assessed several times from the start of treatment up through 12 months following the completion of treatment.
At all points, PE was superior to supportive counseling on all measures. At the end of the study period, 83% of girls in the PE group no longer met criteria for PTSD; the same was true for only 54% of the supportive counseling group (Foa EB et al, JAMA 2013;310(24):2650-2657).
Exposure therapy is a type of cognitive therapy that involves gradually exposing patients to “triggers” related to their trauma and having them recount their trauma in order to help them gain control over the fear that the experience has caused them. Interestingly, the girls randomized to the supportive counseling group were offered the opportunity to talk directly about their trauma, but none chose to do so.
An editorial accompanying the article said some therapists may be reluctant to use this method in such young women because of fear it will cause even more trauma. But in fact, they say, this is the most effective way to treat girls who have been victims of rape and sexual abuse.
FDA Okays Blood Test for Developmental Delay/Intellectual Disability
The FDA recently approved marketing for a new post-natal blood test that will screen for a number of chromosomal abnormalities that are related to intellectual disabilities and developmental delays. The test, called CytoScan Dx Assay and developed by Affymetrix, can detect changes in a child’s genes from conditions such as Down syndrome. The test intended to provide information about the causes of disabilities and delays.
In its review of the test, the FDA found that the Cytoscan Dx performed better at detecting certain chromosomal abnormalities than the most commonly used tests, such karyotyping and the FISH (fluorescent in situ hybridization) test.
The test will be available for use in the first few months of 2014. This test sounds promising for getting to the bottom of the causes of some cases of intellectual disabilities, but regardless of cause, our work lies in providing the best care and services to children with developmental delays and intellectual disabilities. For more information from the FDA, see http://1.usa.gov/1hFr7IL.
Death Within Nuclear Family in Childhood Increases Risk of Psychosis
A new study from the British Medical Journal found that the death of a close family member in early childhood increased a person’s risk of psychotic disorders later in life. Researchers examined a cohort of more than 1 million births between 1973 and 1985 in Sweden to see if prenatal exposure to extreme maternal grief or postnatal bereavement could contribute to psychosis. The group was studied through 2006, when they were between the ages of 21 and 33.
Those exposed to severe maternal bereavement in utero had no excess risk of psychosis. However, exposure to the death of a close family member during childhood increased the risk of both affective and non-affective psychosis.
The earlier in the child’s life the death occurs, the greater the risk (eg, adjusted odds ratio for birth to 2.9 years 1.84, 1.41 to 2.41 vs adjusted odds ratio for ages seven to 12.9 years 1.32, 1.10 to 1.58). In addition, if the death was by suicide, the risk—especially for affective psychosis—was greater than if the death was by other cause (accidents or natural causes). Researchers considered confounding variables, such as socio-economic status, parents’ age, and family history of psychiatric illness—and found that the risk remained elevated in these cases.
Few studies have looked at bereavement in children age three and younger. This study shows that those children may be most vulnerable to long-term effects from losing a parent or sibling. The researchers wrote that these results suggest that younger kids are most at-risk for abnormal brain development that may result from trauma. In addition, they point out, “the earlier in childhood [the death of an immediate family member occurs], the longer a child is likely to be exposed to disruptive social and family effects associated with.. .parental loss.” You can read the full study at Abel KM, BMJ 2014;348:f7679.
Study Finds Multiple Health Disparities for Transgender Youth
New research out of New Zealand reports that teens that identify as transgender have poor safety and well-being across a number of areas in comparison to their non-transgender peers. The study, published in the January 2014 issue of The Journal of Adolescent Health, was part of a national health survey of 8,500 randomly selected high school students in New Zealand. They were asked the question: “Do you think you are transgender? This is a girl who feels like she should have been a boy, or a boy who feels like he should have been a girl.” Based on their answers, students were categorized as transgender, non-transgender, not sure about gender, and didn’t understand the question.
The majority of students identified as non-transgender (95%); while 1.2% identified as transgender and 2.5% were not sure. Most of the transgender students said they had not told anyone close to them that they were transgender.
Among the transgender students, more than 76% said they had a parent who cared “a lot” about them. About 47% said they had friends who cared a lot about them (vs 67% of non-transgender students).
When it came to risks to safety and well-being, transgender students were at increased risk in all areas measured when compared to non-transgender students. Fifty-three percent said they felt unsafe at school and about 50% said they had been hit or harmed at school.
Significant depressive symptoms were reported in 41% of transgender students, vs just 11.8% of non-transgender students. Transgender students also had high rates of self-harm (45.5%) and attempted suicide (close to 20%).
The authors point out that nationally representative research on transgender youth is virtually non-existent; and those studies that do exist tend to lump transgender, gay, lesbian, and bisexual teens into one group. However, identity surrounding gender and sexual orientation can vary widely and combining the two doesn’t allow for clear data about transgender youth. For example, in this study 55% of students who identified as transgender were exclusively attracted to the opposite sex, while 41% were not exclusively attracted to the opposite sex.
This study, while performed outside of the US, paints a troubling picture for all transgender teens. Rates of self-harm and suicide attempt are significantly higher in this population. And factors such as having loving parents and friends may not be enough to protect against bullying and mental health problems. The full study can be read at Clark TC, J Adolescent Health 2014; January 14, online ahead of print.
Positive School Environment Beats Drug Testing for Teens
A supportive school environment results in fewer kids using cigarettes and marijuana compared to a school that uses drug testing, according to recent research out of Rutgers University. However, neither strategy is particularly helpful in reducing teen drinking.
The study, published in the Journal on Studies of Alcohol and Drugs, used data from the National Annenberg Survey of Youth (NASY), an annual telephone survey of American adolescents. Participants were between the ages of 14 and 18 and follow-up was conducted one year from initial contact.
Students were asked if they had ever smoked a cigarette, drank alcohol, or smoked marijuana or hashish. For those who responded yes, frequency of use was assessed. They were then asked if they thought their schools had a positive environment and/or if they were aware of student drug testing in their schools. A “positive school climate” was identified as one that fostered healthy relationships between teachers and students.
Student drug testing was not associated with a reduction in the initiation of smoking cigarettes or marijuana in the study period. Conversely, a positive school environment was, for both substances.
Student drug testing has been a controversial practice since its inception. Some studies show that about 30% of schools use some amount of drug testing, for instance for participation in sports. These programs most often test for marijuana, but they are used for alcohol and other drugs as well. Based on the results of this study, fostering good relationships between students and teachers may a better strategy for schools who want to keep teens off drugs (Sznitman SR & Romer D, J Stud Alcohol Drugs 20l4;75(l):65-73).