Whether generics are really therapeutically equivalent to branded versions of drugs has long been controversial. The US Food and Drug Administration (FDA) requires that generic companies demonstrate “bioequivalence” before they can be marketed, although these studies are conducted with healthy volunteers. Nonetheless, most of our patients are taking generics, and we hardly ever hear complaints.
Rarely, the FDA itself flags problems with generics—as they recently did regarding two generic versions of Concerta (methylphenidate extended-release) (http://Lusa.goy/nVqUyF). The FDA’s action came after it re-examined previously submitted data for the three generic versions of Concerta currently on the market. They found that the generic versions manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland delivered methylphenidate (MPH) at a slower rate over 10 to 12 hours than branded Concerta. Only Janssen Pharmaceutical’s generic version (marketed as Actavis) released MPH at the same rate.
The FDA’s action included downgrading the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. That means these two generics are still approved for use and can be prescribed, but are no longer recommended as automatic substitutes for Concerta.
What this means for prescribers depends on the scenario. Scenario A: Your patient is on one of the slow versions of Concerta and is doing perfectly well—no change needed. Scenario B: Your patient is on a slow generic and isn’t doing well—switch to Concerta or Activis. Scenario C: You are newly starting a patient on Concerta, or switching from brand to generic—specify on your script that you want it to be filled with Activis.
By the way, the FDA told Mallinckrodt and Kudco Ireland in November to fix their products within six months or to voluntarily withdraw them from the market. We’ll keep you apprised.
Omega Fatty Acids Might Help Kids with Attention Deficits
Given new research from Sweden, it won’t hurt—and might help—for clinicians to suggest their patients with attention deficit disorder (ADD) take supplements of the fatty acids omega 3 and 6.
The supplements can help children and adolescents with ADD, which is the inattentive subtype of attention-deficit hyperactivity disorder (ADHD), according to the findings of a dissertation done at the Sahlgrenska Academy at the University of Gothenburg.
In a double-blind study, researchers gave 75 children diagnosed with ADHD either omega 3 and 6 or a placebo over three months. Then they gave all the participants the fatty acid supplements over the next three months. While there was no major improvement for the group as a whole, the researchers found in 35% of the participants who had ADD, there was an improvement in symptoms, including being attentive for more than short periods of time. Blood samples also showed those children with an improvement had a better balance between the two fatty acids.
The research also found that a cognitive training program, called Collaborative Problem Solving (CPS), can improve problem behavior in children with ADHD, according to a university news release (http://bit.ly/1pKwWwN). It can be a good alternative or complement in the treatment of ADHD, as well as oppositional defiant disorder (ODD), researchers found. The study included 17 children, who along with their family members, received up to 10 weeks of help in training cognitive ability and solving problematic situations. The families were then asked how much the child’s behavior problems improved immediately after treatment, as well as six months later. Half reported a large or very large improvement.
Those who still experienced severe ADHD symptoms at completion of the CPS training were given the chance to supplement treatment with stimulant medications. In a six month follow-up, 81% of all the participating families experienced a large or very large improvement, according to the university news release. Go to http://hdl.handle.net/2077/36752 to read the dissertation.