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.