Off Label Drug Use

By Author: Henry Ford
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Off label drug use involves prescribing drugs by the physicians for an approved indication. The FDA has approved the use of drugs off label. Off label drug use has become common and research has shown that it has risen by approximately 31% (Radley, 2006). The rise in the use of off label has been because most drugs are not tested for safety especially in children. Hence pediatricians prescribe off label drugs. This prescription is also common in cardiac medications and is also commonly used as anticonvulsants. However, off label drug use is not scientifically supported or has very little scientific support (Radley, 2006). Adderall is a drug that can be abused hence it is a federally controlled drug.

Amphetamine is a drug prescribed for treating attention deficient hyperactive disorders (ADHD) in adults and children. It works by increasing the levels of dopamine and norepinephrine in the brain leasing to increased levels of attention and prolonged concentration time. There has been an increase in the abuse of the same when it is used off label. College students are abusing it by using it as a study drug and this is posing ...
... a great threat. The drug is prescribed off label by physicians to patients suffering from depression. It is also used to suppress appetite in people who wish to loose weight. Adderall was widely used as a speed drug to loose weight. Many health care providers have prescribed it as a weight loss medicine.. Though FDA disapproved its use as a weight loss medicine in 2007, the use of addenall as a treatment to obesity has increased of late due to modern society’s obsession of keeping fit. Methamphetamine which is sold under the brand name Desoxyn is however approved for the treatment of obesity. Though addenall has not been approved by the Food and Drug Administration as a drug for treating obesity, it is legal and therefore doctors have been prescribing it as an off label medication. The use of addenall has been popularized due to its quick and drastic effects. Obesity is a common condition and it has become a great threat especially to young children. This has affected many children leading to severe health problems before they are 10 years old. Therefore doctors are prescribing it as an off label drug to treat this condition and avoid diabetes (England, 2007).

Teenage obesity has also increased and this has made them susceptible to type 2 diabetes. Obesity has also had a psychological impact on these teens as they are usually bullied, made fun of and harassed. This reduces their self esteem. But the use of addenall as a treatment to weight loss has remained controversial. Dr Fuad Ziai who is a pediatric endocrinologist was in the news and he publicly supported use of addenall as a weight loss drug. He reported that of the 800 children and teenagers whom he prescribed the drug to, almost 90 % have lost weight (Cohen, 2007). This has raised many concerns especially on ethical grounds from the media, parents and also medical practitioners. The following case study explore the off label use of Amphetamine (Aderall) for obese teenagers

Case study
An obese teenager presents himself to his doctor with a severe case of diabetes. He is 13 years old, weighs 40 pounds and some blood tests previously carried out on him shows that he is bound to have type two diabetes. The teenager has been active physically, has been working out well and his diet has been healthy.
I am a 17 years old obese teenager who has been trying all the available ways of loosing weight without success. I started being obese when I was five years old and my parents took me to several pediatricians who advised us that the only solution to lose weight was to eat a well balanced healthy meal. They tried their best but my weight kept on increasing. I have suffered a lot of humiliation, mockery and harassment in school due to my overweight.
Mr. V has taken other drugs and products like pyruvate, laxatives, diuretic drugs and diet pills which has not been effective in improving his condition.

Problem: 17 year old male patient, physician order for Amphetamine (Addenall) which is an off label medication.
Comparison: Compared to no drug treatment
Intervention: administer the medication or not
Outcome: the patient will demonstrate improved weight loss, reduced appetite and increased body metabolism and reduced vulnerability to type two diabetes.

Question: Given the information in the case study, will the administration of Amphetamine (Aderall) be safe and effective for this 17 year old young man?
There are many studies which have been carried out and which have shown that there is a relationship between Attention Deficient Hyperactivity Disorder (ADHD) and obesity. But there has not been any scientific study that has been carried out to evaluate the effectiveness of using adderall as a weight loss medication. Therefore it becomes risky and dangerous to prescribe this drug for treating obesity. Evidence shows that obese people have a high prevalence of ADHD. ADHD leads to obesity through abnormal eating behaviors. The impulsivity that is associated with spree eating in obese patients has been shown to cause ADHD (Cortese, 2008).

The latest statistics shows that around 58 million Americans are overweight, 40 million are obese and 3 million are morbidly obese. The high numbers of obese people means that the risk of having health problems is high. Therefore, a link exists between ADHD and obesity. This means that taking adderall for treatment of ADHD, leads to a reduction in weight loss and therefore reduced prevalence to obesity. Other studies have however shown that use of these stimulant medications to treat ADHD has led to sudden death in children and adolescents and these deaths are unexplainable. But the researchers who carried out this study stressed to both parents and doctors that this was not a cause to stop using adderall. This study was carried out by comparing of children and adolescents and also interviewing the parents of those who had died. It concentrated on the deaths of teenagers between 1985 and 1996. Among these, 564 had died from heart rate abnormalities or other unexplained causes. From the unexplained causes, the researchers found out that 1.8% of these people were using stimulant medication (Gould, 2009).

The FDA recommended that manufacturers of stimulant should include a warning label to their drugs that should prohibit use of the drug in children with heart abnormalities. The study carried out by Gould was not meant to dismiss use of stimulants but to stress their use after a careful diagnostic assessment. The unexplained sudden death is not a factor that can be used to dismiss use of Adderall or any other stimulant both off label and on label prescription. It becomes hard to conduct such a study without flaws because it is ethically impossible to carry out a placebo-controlled trial. Other studies have been carried out to determine the long term effect of using amphetamine. From the study it was found that high doses of amphetamine damaged dopaminergic pathways. But there are other researches which have contradicted these findings. In short there is need for more comprehensive studies to determine where use of amphetamine for treating ADHD has any neurological effects (J. of Att. Dis. 2007).

The manufacture of this drug, Shire, collected some data in the year 2007 which showed that the drug was associated with the sudden deaths of 12 children in America between the 1999 and 2003. But there was no evidence to show that adderall caused an increase in cardiac defects. Of the 12 children who died due to used of Adderall, 5 were suffering from known cardiac conditions, one died due to strenuous exercises performed at 110 degrees heat while the other two had evidence of an overdose. Even after these findings and the fact that approximately 37,000,000 prescriptions of this drug had been carried out in that 4 year period, FDA did not see this as an increase in the sudden death of adderall users (Medic8.com, 2009).

Health Canada had banned all the sales of this drug in 2005 after the Shire report but it later lifted this ban after recommendations from a committee report of findings carried out by three independent physicians. Currently, the warning presented by FDA and Health Canada concerning adderall use only prohibits its use by people with cardiac and mental disorders. The four salts found in adderall are said to metabolize at different rates. The manufacturer states that these salts makes the effects of the drug smoother but there is no scientific evidence to prove this fact. A double blind, placebo- controlled study on children conducted recently showed that the behavior of the patients was similarly to other amphetamines. Adderall is usually sold either as an immediate release tablet or as an extended release tablet. The later has a high bioavailability and hence its effectiveness is not affected by food absorption.

After taking the drug, some patients reported that their creativity decreased while others reported an increase in their creativity. Double blind placebo controlled experiments have been carried out in normal subjects and they have shown increased performance in their cognitive tasks and a decrease in the time taken to react.

Untreated obesity is harmful in its own way. The risks associated with adrenal usage as a weight loss drug are usually overlooked. This is because obese teenagers find obesity as more threatening and less comforting. Many people who have this condition are usually desperate and this has prompted them to use various methods of weight loss. When most of these methods have failed, adderall has been seen as a solution due to its effects on reducing weight. Those people who have used it have shown reduction in weight even with continued use of unchecked diet. The main issue of taking amphetamines as a treatment to obesity is that it may lead to other problems especially when one is not suffering from ADHD. When taken regularly to reduce weight, it can affect ones emotional side leading to low motivation and depression. Long term use of this drug can lead to addiction. Though many medical practitioners have prescribed adderall to be used for treating obesity, there is fear that the disease can cause strokes, heart attacks and even sudden death. There is an increase in the use of adderall as a study drug among college students. This is due to its ability to enhance concentration to a higher level than normal. It has been used by these students to read for long hours without getting tired or cramming for important papers without loosing concentration. When used for extended periods of time, it can be addictive. Other off label uses of the drug includes epilepsy, autism and senile apathetic behavior.

Some of the major side effects of Adderall include headaches, insomnia, increased energy, motivation and alertness, decreased libido bladder problems that are coupled with painful and frequent urination, decreased appetite and an increase in the heart rate. There are other less common side effects that include dilation of the pupil, stomach upsets, fever, urinary retention, head aches, coughing, hoarseness and anxiety and nervousness. The side effects which have been known to occur rarely include stroke and sudden death. These effects are known to occur in when prescribed on label to treat ADHD. Therefore they may be more severe when prescribed off label to treat. There have not been clinical trials and studies to establish the effectiveness of adderall as a weight loss medication. There have not been controlled tests that have been carried out to show the mechanism and effect of using adderall as a drug to treat obesity.

After reviews of this literature, I would use caution when administering adderall to the patient presented in the case study. Though adderall has been claimed to reduce weight, its long term consequences and effects are unknown. Furthermore it is a drug that one can be hooked to and this has consequences as well. What is better between being hooked up to a drug or remaining obese? This is a question that is hard to answer and can only be well answered by a person who has suffered ridicule or who has been bullied due to being obese. The desired outcome for this patient would be weight loss, reduced appetite and increased body metabolism and reduced vulnerability to type two diabetes. There is need to carry out more research on the use of this drug and its effects as a weight loss medication.

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