The US Food and Drug Administration (FDA) issued a Public Health Advisory to alert physicians of reports of suicidal thinking in children and adolescents associated with Strattera.
FDA has also directed Eli Lilly and Company, manufacturer of Strattera, to develop a Medication Guide for patients and caregivers.
The FDA is advising that
…health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for worsening of symptoms as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed (either increased or decreased).
This monitoring should include daily observation by families and caregivers and frequent contact with the physician.
0.4% of children treated with Strattera reported suicidal thinking (five children out of 1,357) compared with no cases in children treated with the placebo.”
There were no actual reports of suicide. There was one attempt out of the 2200 people in the trial.
According to an email I received from a Lily representative, the child who attempted to commit suicide took several times the recommended dose. People wanting to contact Lily directly on this can call to Eli Lilly’s Customer Response Centre at tel: 1-888-545-5972 (8:00 a.m. to 6:00 p.m. ET).
Based on the data, the FDA has determined that the following points are appropriate for inclusion in the boxed (black box) warning:
* Strattera increases the risk of suicidal thinking in children and adolescents with ADHD.
* Anyone considering the use of Strattera in a child or adolescent for ADHD must balance the increased risk of suicidal thinking with the clinical need for the drug.
* Patients who are started on therapy should be observed closely for clinical worsening, suicidal thinking or behaviors, or unusual changes in behavior.
* Families and caregivers should be advised to closely observe the patient and to communicate changes or concerning behaviors with the prescriber.
One researcher noted that 25% of children with ADD had depression.
just wondering if there are any adults on strattera,, and if so do any of you have the sic to your stomach and the hard to urinate or get the urine out side effects??
and do you sometimes get weird feelings and thoughts from it??
i’m thinking of going off it ’cause sometimes it is a pain to feel sic all the times and the reason i take the meds. if so i’m not such an embarassement to my husband. rainielee
different medications have different side effects, with those side effects I’d suggest talking to your doctor to see what he says, he may change medications or adjust the dose
I have been on Straterra for about a month. Doc gave me 40mg for a week then 80mg. I feel like there is a cat scratching in my belly a lot. And I also have started to feel very confused emotionally. I am on that as well as Adderall and I no longer feel the effects of the adderall. It has cancelled it out. I can be very sleepy. I am going to see if the doctor will see me earlier and prescribe something else. I guess thats why there are so many meds. Different meds for different people.