adhd - Drugs for ADHD

strattera (pronounced Stra-tair-a) (atomoxetine) is a non-amphetamine drug approved in December 2002 for treatment of ADHD. Under the Controlled Substances Act, it is not classified as a stimulant and thus is not a controlled class two drug. Since it is not an amphetamine, Lilly was able to persuade the FDA not to classify it as a controlled substance. They try to stretch this classification to say that it is not a stimulant drug, which is a deceptive use of the FDA language. FDA never said it is not stimulating. Coffee is stimulating, but the FDA does not classify it is a controlled drug. And, this does not allow Starbucks to claim its coffee is not a stimulant. strattera clearly functions as a stimulant, though not as strongly as amphetamines do. This may also be why it is not as effective as the stimulants. It also has most of the same side-effects of the stimulants. But, Eli Lilly seeks to avoid the "bad name" associated with amphetamines stimulants commonly used to treat ADHD.

No studies show that Strattera works better or has less side effects than stimulants. In fact, a study in the Journal of attention Disorders in 2005 showed that Strattera to be less effective than stimulants in reducing the symptoms of ADHD. Another study found that children who start drug treatment with Strattera were 4 times more likely to change drugs than children who started on a stimulant. In terms of drug treatment, nonstimulants should be considered after stimulant treatment has been unsuccessful.

In addition, Strattera doesn't cause many of the potential side effects linked to psychostimulants, such as sleeplessness. However, Strattera can cause other side effects including abdominal pain, nausea, and drowsiness, especially when starting the medication. What Strattera does better than the stimulant medications is provide a longer and smoother action without the "roller coaster" effect of the stimulant starting to work and then wearing off. Since it does not cause a "high," it does not lead to abuse. Since it is not a controlled drug, it may used with those who have a history of drug abuse. Also, since it is not a controlled drug, your doctor can call in refills to your pharmacist.

Dosage

With a half-life of 5.2 hours, it makes no difference whether it is given once or twice per day. Theraputic effects usually begin within a few days to one week. The full effect may not be reached for a month or more. Action is 24/7 as long as is is taken daily. This avoids problems of rebound and gaps in coverage. Thus it is has a longer and smoother effect as compared to the "roller coaster" effect of stimulants.

Dosage is based on weight. Typical starting dosage is .27 mg/lb/day. The usual optimal dose is .55 mg/lb/day.

Capsules come in 5, 10, 18, 25, 40, and 60-mg sizes and can be taken once or twice a day.

Side effects

Like the stimulants, side effects of Strattera include poor appetite, nausea, vomiting, tiredness, weight loss and upset stomach. It does not cause the insomnia that amphetamines sometimes do.

Allergic reactions to Strattera do occur but are rare. They usually appear as a skin rash, swelling or hives. Seek medical help immediately if these or other allergic symptoms appear.

It may slow growth in children and teens. This should be monitored closely.

FDA Warnings About Severe Liver Injury possible from Strattera
Number of actual cases of severe liver injury is unknown because of under-reporting


The Food and Drug Administration (FDA) is advising health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children. The labeling is being updated with a bolded warning about the potential for severe liver injury following two reports (a teenager and an adult) in patients who had been treated with Strattera for several months, both of whom recovered.

FDA Warnings for Strattera after Severe Liver Injury of Two Reported Cases

Warning Issued Dec 17 2004
The labeling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients. The labeling also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of post-marketing adverse events.

The bolded warning indicates that the medication should be discontinued in patients who developed jaundice (yellowing of the skin or whites of the eyes) or laboratory evidence of liver injury.

Strattera has been on the market since 2002 and has been used in more than 2 million patients. In clinical trials of 6000 patients, no signal for liver problems (hepatotoxicity) had emerged.

The FDA has asked the manufacturer to add a bolded warning about severe liver injury to the labeling. Eli Lilly has agreed to alert health care professionals about the new information in a Dear Health Professional letter. The company will also update the patient package insert with information about the signs and symptoms of liver problems, which include:
Pruritus (Itchy skin)
Jaundice
Dark urine
Upper right-sided abdominal tenderness
Unexplained “flu-like” symptoms


 

The Food and Drug Administration (FDA) is advising health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children. The labeling is being updated with a bolded warning about the potential for severe liver injury following two reports (a teenager and an adult) in patients who had been treated with Strattera for several months, both of whom recovered.

FDA Warnings for Strattera after Severe Liver Injury of Two Reported Cases

The bolded warning indicates that the medication should be discontinued in patients who developed jaundice (yellowing of the skin or whites of the eyes) or laboratory evidence of liver injury.

Strattera has been on the market since 2002 and has been used in more than 2 million patients. In clinical trials of 6000 patients, no signal for liver problems (hepatotoxicity) had emerged.

The FDA has asked the manufacturer to add a bolded warning about severe liver injury to the labeling. Eli Lilly has agreed to alert health care professionals about the new information in a Dear Health Professional letter. The company will also update the patient package insert with information about the signs and symptoms of liver problems, which include:

Read more about Strattera by www.adhdtreatment.org