ADHD drugs

FDA Reviews Health Risks of ADHD Drugs

(taken from various news sources)


A panel of advisors recently reviewed information and reports about the consequences of children being prescribed drugs for the inflated ADHD diagnosis. The drugs in question are mostly addictive stimulants that have resulted in side effects such as hallucinations and cardiovascular problems.


In February another panel voted 8-7 in favor of putting the Food and Drug Administration's (FDA) strongest "black box warning" label on this class of drugs, yet the recent panel fell short of that, and instead recommended only supplying more information regarding the risks.


The February drug safety panel acted after learning that 25 persons died suddenly while taking such drugs and that 54 experienced serious cardiovascular disorder during that period while on ADHD drugs between 1999 and 2003.


The Food and Drug Administration will consider both panels' recommendations before making a final labeling decision.


About 2 million children and 1 million adults are prescribed medications for ADHD each month. According to the FDA, adult use of the drugs nearly doubled between March 2002 and June 2005.


Some critics say the drugs are over-prescribed to people who do not need them, while others think they are a danger to the well-being of children and adults altogether.


Drugs used to treat ADHD (for which there is no physical or blood test to detect) include Ritalin, Concerta, Focalin, Dexedrine, Strattera and Adderall. Adderall already has one black box warning that the drug could lead to heart problems, and Strattera, which is a non-stimulant, has one cautioning that children and teens who take it could have suicidal thoughts.


One report cited that FDA staff said they were struck by incidents of several children under age 10 who were taking the drugs and thought they saw or felt bugs, snakes and worms crawling on them. This is also a common symptom of people taking the illegal drug methamphetamine.


According to the National Library of Medicine, other known side effects of ADHD drugs are:


Nervousness, difficulty falling alseep or staying asleep, dizziness, upset stomach and vomiting, loss of appetite, stomach pain, diarrhea, headache, runny nose and other cold symptoms, seizures, blurred vision, agitation, abnormal thoughts, hallucinations, depression, heart palpitations or irregular heartbeat and stunted growth and development.


DEA Congressional Testimony

Statement by Terrance Woodworth Deputy Director Office of Diversion Control Drug Enforcement Administration before the Committee on Education and the Workforce: Subcommittee on Early Childhood, Youth and Families on May 16, 2000.

The DEA is the agency responsible for the regulation and control of substances with abuse potential that are subject to the Controlled Substances Act (CSA). In this regard, the DEA provides for the production of sufficient material to meet the legitimate need for controlled substances, but at the same time, minimizes the amount of these substances available for diversion. In striving to maintain this balance, the DEA has made every effort to keep the health and safety of our young people uppermost in our mind. Of the many psychoactive substances prescribed to young children in the United States, only two controlled substances are widely utilized by American physicians to treat children: methylphenidate (commonly known as Ritalin®) and amphetamine (primarily Adderall® and Dexedrine®). Both are approved and used in the treatment of attention deficit (hyperactivity) disorder referred to as ADHD or ADD. Both of these substances are powerful stimulants that have been in Schedule II of the CSA since 1971. Schedule II of the CSA contains those substances that have the highest abuse potential and dependence profile of all drugs that have medical utility.

In 1995, in response to a petition by Children and Adults With Attention Deficit Disorder (CH.A.D.D.) and the American Academy of Neurology to lower the regulatory controls on methylphenidate, the DEA conducted an extensive review of the use, abuse liability, actual abuse, diversion, and trafficking of methylphenidate. The CH.A.D.D. petition characterized methylphenidate as a mild stimulant with little abuse potential - this is not what our review found and the petitioners subsequently withdrew their petition. In December 1996, the DEA held a conference on "Stimulant Use in the Treatment of ADHD". We gathered experts in the fields of ADHD research and treatment, psychiatry, social work, ethics and law enforcement who offered their expertise and unique perspectives to the many controversial topics related to ADHD and its treatment. In addition, the DEA participated in the 1998 National Institutes of Health (NIH) Consensus Conference. In 1998 and 1999, the DEA was invited to the Council of Europe to participate in joint meetings with the Pompidou Group and the International Narcotics Control Board (INCB) to discuss the control of stimulants in Europe and the diagnosis and treatment of ADHD with stimulants. Today, I will present a summary of the data we have gathered about the use of Ritalin and like drugs. These data show:

- The expansive use of these drugs for childhood behavioral disorder in the United States differs significantly from medical practices in the rest of the world (United Nations data).

- Poison control data, emergency room data and high school surveys all indicate that the abuse of methylphenidate has increased significantly since 1990.

- A number of questionable practices have contributed to the diversion and abuse of stimulant medication including improper diagnosis, lack of adequate information to youth, parents, and schools regarding the abuse potential of these drugs and lax handling of medication (Consensus statement, 1996 DEA Conference).

The DEA has observed a dramatic increase in the production and use of both methylphenidate and amphetamine. Each year, the DEA establishes an aggregate production quota (APQ) for each Schedule I and II controlled substance. This quota is based on sales and inventory data supplied by the manufacturers as well as information supplied by the Food and Drug Administration (FDA) regarding legitimate medical and research needs. The methylphenidate quota has increased from 1,768 kilograms in 1990 at which time there were two bulk manufacturers and four dosage-form manufacturers. This year, the APQ is 14, 957 kilograms with six bulk manufacturers and 19 dosage form manufacturers. Prior to 1991, domestic sales reported by the manufacturers of methylphenidate remained stable at approximately 2,000 kilograms per year. By 1999, domestic sales increased by nearly 500 percent. The amphetamine APQ has increased from 417 kilograms in 1990 with two bulk manufacturers and seven dosage form manufacturers. This year's amphetamine APQ is 9,007 kilograms with six bulk manufacturers and 19 dosage form manufacturers. This is more than a 2,000 percent increase for amphetamine in nine years.

The increases in production and use of methylphenidate are even more striking when compared to worldwide data. According to the United Nations, the U.S. produces and consumes about 85 percent of the world's production of methylphenidate.

Extensive scientific literature spanning over 30 years of research unequivocally indicates that both methylphenidate and amphetamine have high abuse liabilities: They are self-administered by laboratory animals and humans; They produce discriminative stimulus effects similar to cocaine in laboratory animals and humans; They will substitute for each other and for cocaine in a number of paradigms in both animal and human subjects; Chronic high dose administration of either drug in animals produces psychomotor stimulant toxicity including weight loss, stereotypic movements and death; In clinical studies, they produce behavioral, psychological, subjective, and reinforcing effects similar to cocaine.

In more simplistic terms, this data means that neither animals nor humans can tell the difference between cocaine, amphetamine, or methylphenidate when they are administered the same way at comparable doses. In short, they produce effects that are nearly identical.

A significant body of literature is available that describes the actual abuse of methylphenidate and consequences associated with that abuse. Like amphetamine and cocaine, abuse of methylphenidate can lead to marked tolerance and psychic dependence. Methylphenidate can be abused orally or tablets can be crushed and snorted or dissolved in water and injected. The pattern of abuse is characterized by escalation in dose, frequent episodes of binge use followed by severe depression and an overpowering desire to continue the use of this drug despite serious adverse medical and social consequences. Typical of other central nervous system stimulants, high doses of methylphenidate often produce agitation, tremors, euphoria, tachycardia, palpitations, and hypertension. Psychotic episodes, paranoid delusions, hallucinations, and bizarre behavioral characteristics similar to amphetamine-like stimulant toxicity have been associated with methylphenidate abuse. Severe medical consequences, including death, have been reported. Although the majority of the cases cited in the literature pertain to adults, case studies have profiled adolescents who abused their prescribed methylphenidate medication. This body of literature indicates that the improper use of methylphenidate can pose a serious risk for the user.

Unlike amphetamine, methamphetamine and cocaine where illicit manufacturing accounts for the vast availability of these drugs for abuse, pharmaceutical products diverted from legitimate channels are the only sources of methylphenidate available for abuse. Diversion of methylphenidate has been identified by drug thefts, illegal sales, prescription forgery, and various scams involving doctor shopping. From January 1990 to May 1995, methylphenidate ranked in the top ten most frequently reported controlled drugs stolen from registrants. From January 1996 to December 1997, about 700,000 dosage units of methylphenidate were reported to our drug theft database. In 1998 there were 376 reported thefts from pharmacies. Night break-in, armed robbery, and employee theft are the three major sources of this diverted methylphenidate. In addition, the DEA has received a significant number of reports of methylphenidate theft at unregistered locations, primarily at schools and homes where methylphenidate supplies are kept. It is important to note that many schools have more methylphenidate on hand for student daytime dosing than is available in some pharmacies. While State and Federal laws require accountability of controlled substances by licensed handlers, no such requirements are imposed at schools.

The manner in which medication is handled at schools has provided an opportunity for some individuals to divert and abuse this medication. For example, a highly respected teacher was videotaped stealing methylphenidate from the nurse's office the evening of an awards ceremony that was honoring him as "teacher of the year." In another incident, a school nurse who was responsible for safeguarding student medications, stole the children's methylphenidate for her own use. In a school that required students to provide a doctor's prescription for proof of medication need, the principal was discovered taking the methylphenidate prescriptions, forging his name and filling them in pharmacies throughout the state for his own personal use. Students have been discovered taking medication from a teacher's desk where medication was being stored. A student who left home with a month's supply of medication, arrived at school with only six tablets having distributed the others to friends on the bus on the way to school. Schools have been broken into and medication supplies have been taken. In some of these reports, the school had no idea exactly how much or whose medication was taken. It is not at all surprising that these types of activities could occur. A 1996 DEA sampling of practices employed by schools for the handling of medication indicated that most schools did not have a nurse dispensing medication. Frequently supplies were kept in unlocked desks and a variety of people were tasked with giving medication to the students: school secretaries, parent aides, teachers and, in one school, the janitor was given that responsibility. Few schools kept records of drugs. At any given time, many schools may have no idea how much medication they should have. Although most schools had regulations prohibiting students from having drugs in their possession, many junior and senior high school students carried or administered their own medication.

Methylphenidate is sought after by a wide range of individuals. Information from DEA case files and State investigative services indicate that methylphenidate has been involved in criminal drug trafficking activities including street sales as determined by undercover buys, multi-state distribution rings, multi-drug distribution rings (with cocaine, LSD, marijuana, hydromorphone, diazepam, anabolic steroids) and smuggling from Mexico.

In addition, numerous states have reported "Attention Deficit Scams" (a parent or other adult who takes a child who purportedly has ADHD to a number of physicians to obtain methylphenidate prescriptions- the adult obtains the drug for their own use or to sell or trade for other drugs).

The magnitude and significance of methylphenidate diversion and trafficking is comparable to pharmaceutical drugs of similar abuse potential and availability (like morphine sulfate). There is little doubt that Schedule II controls and the lack of clandestine production have limited the illegal use of this drug. However, reports of methylphenidate misuse/abuse among adolescents and young adults is particularly disturbing since this is the group that has the greatest access to this drug. Adolescents don't have to rob a pharmacy, forge a prescription or visit the local drug dealer to acquire methylphenidate - they have little difficulty obtaining it from a friend or classmate at school. Reports from numerous states and local municipalities indicate that adolescents are giving and selling their methylphenidate medication to friends and classmates who are frequently crushing the tablets and snorting the powder like cocaine. In addition, anecdotal reports from students and faculty on college campuses indicate that methylphenidate is being used as a study aid and a party drug in the same manner that amphetamine was used on campuses in the 1960s.

Study: ADHD drugs send thousands to ERs

By Linda A Johnson - Associated Press

Accidental overdoses and side effects from attention deficit drugs likely send thousands of children and adults to emergency rooms, according to the first national estimates of the problem.

Scientists at the U.S. Centers for Disease Control and Prevention estimated problems with the stimulant drugs drive nearly 3,100 people to ERs each year. Nearly two-thirds - overdoses and accidental use - could be prevented by parents locking the pills away, the researchers say.

Other patients had side effects, including potential cardiac problems such as chest pain, stroke, high blood pressure and fast heart rate.

Concerns over those effects have led some doctors to urge the Food and Drug Administration to require a "black box," its most serious warning, on package inserts for drugs such as Ritalin, Concerta and Adderall...

Read the full AP article here.