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FDA Black Box Warning Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. |
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FDA Black Box Warning Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. |
Lisdexamfetamine (VYVANSE), which is used to treat attention-deficit/hyperactivity disorder (ADHD), has the potential to cause dependence and adverse effects on the heart, including sudden death.
Patients treating ADHD should think twice before using lisdexamfetamine: The drug is more expensive than (and does not treat ADHD better than) older, safer alternatives (such as methylphenidate [RITALIN]).
Lisdexfetamine, approved in 2007 by the Food and Drug Administration (FDA), is taken orally. It is rapidly absorbed and converted into dextroamphetamine, responsible for the drug’s pharmacologic effects, and the amino acid L-lysine.
Lisdexamfetamine is technically classified as a new drug, but the active ingredient dextroamphetamine was first patented in the U.S. in 1942. The drug is an old chemical that has been around for more than 60 years but has been repackaged and sold at higher prices. With 3.09 million prescriptions filled in 2008, this drug ranked No. 97 on the list of the most-frequently-prescribed brand name drugs in the U.S. that year.
The table on this page lists other drugs approved for ADHD in the U.S. and our recommendations for their use.
Drugs Approved by the FDA to Treat ADHD
|
Atomoxetine |
STRATTERA*** |
|---|---|
|
Dexmethylphenidate |
FOCALIN, FOCALIN XR* |
|
Amphetamine/Dextroamphetamine Mixed Salts |
ADDERALL; ADDERALL XR** |
|
Dextroamphetamine |
DEXEDRINE** |
|
Methylphenidate |
RITALIN** |
|
Methylphenidate Extended-Release |
CONCERTA** |
* Do Not Use in Worst Pills, Best Pills ** Limited Use in Worst Pills, Best Pills
*** Do Not Use Until 2010 in Worst Pills, Best Pills (This drug to be reclassified in 2010.)
What evidence did the FDA use to approve this drug?
The FDA approval of lisdexamfetamine was based on two clinical trials that included 263 subjects who received various dosages of the drug.
The first trial tested lisdexamfetamine against a placebo and amphetamine/dextroamphetamine mixed salts (ADDERALL). The effects of the drug were measured using a scoring tool known as the SKAMP-DS, which rates the drug’s effects on a scale of 0 to 6.
The average difference on the SKAMP-DS scale between lisdexamfetamine and the placebo, on this scale of 0 to 6, was 0.9 points. Although this result was statistically significant, the FDA medical officer who reviewed the drug’s application questioned whether a 0.9-point difference was substantively important in the patients’ treatment.
In this trial, there was no difference in the average SKAMP-DS score between lisdexamfetamine and amphetamine/dextroamphetamine mixed salts; this suggests that lisdexamfetamine works just as well as, but no better than, amphetamine/dextroamphetamine mixed salts.
The second trial compared three different dosages of lisdexamfetamine to a placebo. In this study, the drug was found to perform better than the placebo.
The second study revealed no extra advantage with doses of the drug greater than 30 milligrams per day.
What is known about the safety of this drug?
Amphetamines, including lisdexamfetamine, raise heart rate and blood pressure and therefore can cause heart problems or make them worse.
Psychiatric side effects include behavior changes, bipolar illness, and aggressive behavior or hostility. In children and teenagers, new psychotic symptoms may develop, such as hearing voices, believing things that are not true, being suspicious or acquiring new manic symptoms.
The common side effects associated with the use of lisdexamfetamine and other amphetamines include dizziness, irritability, weight loss, decreased appetite and trouble sleeping.
Lisdexamfetamine must display a black box warning in its FDA-approved professional product label (see above) about the drug’s potential to cause dependence and adverse effects on the heart, including sudden death.
What You Can Do
We agree with the editors of The Medical Letter on Drugs and Therapeutics, an independent source of drug information, who concluded that: There is no evidence that lisdexamfetamine dimesylate offers an advantage over any other formulation of amphetamine for treatment of children with ADHD. Older drugs with better established dosages and safety records are preferred.
Because this drug has been shown in clinical trials to work only as well as, but no better than, existing drugs for ADHD, there is no reason to use lisdexamfetamine rather than one of the older amphetamine-containing products. We are listing this drug as a Do Not Use: Bad Buy. This means that we do not think you should use it because it is no better than a drug that costs less.
Lisdexamfetamine must be dispensed at the pharmacy with an FDA-approved medication guide that can be accessed on the Internet at: www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
Read the medication guide for lisdexamfetamine before using this drug.
