ADHD Drug Risk: How Are Pharma/Associations Responding?
Many of you may be aware of the recent news coming out of last week’s FDA panel meeting on the heart risk associated with the use of stimulants like Ritalin for the treatment of ADHD. By a vote of 8 to 7, the panel supported placing strong “black box” warnings on labeling for the medications citing the heightened risk of sudden death for children and adults using the drugs. During the panel meeting, FDA officials noted that there were 25 sudden deaths among children and some adults taking the drug. According to the FDA analysis the stimulants might increase the risk of strokes and arrhythmias in children and adults.
Panel members voting for the black box warning said they did so to slow the sales of the stimulants. Dr. Steve Nissen, a member of the panel, said that he wants “to cause people’s hands to tremble a little bit before they write that prescription.” (Thanks to Medpundit for highlighting Nissen’s choice of words.)
With so much attention focused on the FDA, I wondered whether pharmaceutical companies and medical associations were saying anything about this issue. As it turns out, many pharmaceutical companies have been pretty mum.
Novartis, which manufactures Ritalin, simply said that it will cooperate fully with FDA efforts to measure the risk of cardiovascular events due to Ritalin. Johnson & Johnson, which makes Concerta, said the same thing.
Eli Lilly and Company, which makes the ADHD medication Strattera, appears to be in the clear. Strattera is not a stimulant and the panel excluded the medication from its recommendations.
Shire, which makes Adderall and Adderall XR, had the most to say about this issue. The company issued a statement on February 10 in which it asked for additional study before a black box warning is slapped on stimulants’ labels.
“Shire believes that the interests of physicians and patients would be better served by further study to determine whether there is, in fact, a relationship between these medicines and cardiovascular events. Obtaining this information is crucial prior to taking what would be an unprecedented action to include something in a black box that is not been supported by sufficient data.“
Shire also noted that Adderall and Adderall XR already have warnings on their labels regarding cardiovascular risk and abuse.
“Of note is the fact that our Adderall XR and Adderall already include a “black box warning” in their labels for safety concerns related to amphetamine abuse or misuse. The label also warns of the risk of sudden death in patients with structural cardiac abnormalities. We stand behind this labelling and believe that further action is unwarranted.”
Interestingly enough, one of the nation’s leading mental health advocacy organizations, the National Mental Health Association (NMHA) has not yet issued a statement on this issue. However, Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD) has urged parents and children not to be alarmed by the FDA panel’s decision and to continue taking ADHD medications. The group suggests that more study is needed.
Like industry, the American Academy of Child and Adolescent Psychiatry (AACAP) and the American Psychiatric Association (APA) have pledged to work with the FDA to determine the prevalence of adverse events relating to stimulant use.
“The AACAP and APA are committed to working with the FDA to determine the prevalence of rare, unexpected, and serious adverse events to better estimate risk for taking these medications. The Child and Adolescent Psychiatry Trial Network (CAPTN), sponsored by NIMH and AACAP, is a large simple trials network and is one avenue to study these issues. This practice network will provide protocol-driven, postmarking surveillance for youth treated with ADHD medications to track such low frequency adverse events prospectively.”
It will be interesting to see whether Eli Lilly tries to further position Strattera as a safer alternative to stimulants for children and adults with ADHD. If it does choose this strategy, the company might want to be very careful. In the days after Vioxx was removed from the market Pfizer touted the safety and efficacy of its cox-2 inhibitors Bextra and Celebrex. This turned out to be a premature move. Shortly after, Bextra was withdrawn from the market and Pfizer was asked to include a black box warning on Celebrex’s label.
With some critics of stimulant use suggesting that the cardiovascular risk associated with stimulant use is higher than that seen with Vioxx, expect this issue to escalate. It will be interesting to see how industry and patient advocacy organizations respond over time.
