FOCALIN

DESCRIPTION / DEFINITIONS: The active ingredient in Focalin® is dexmethylphenidate hydrochloride – a central nervous system (CNS) stimulant approved by the FDA to prescribe for the set of symptoms known as Attention Deficit Hyperactivity Disorder (ADHD)

ABUSE: Focalin has a high potential for abuse. See more information below.

ADDICTION / DEPENDENCE: Focalin also has a high potential for addiction and dependence. See FDA warning below, as well as information on Focalin’s half life and metabolism.

SIDE EFFECTS: The list of side effects is long and includes anorexia, aggressive behavior, abnormal liver function, hair loss, and tachycardia. See list below.

WITHDRAWAL SYMPTOMS: Body pains and severe depression are among the withdrawal symptoms. See list below.

TREATMENT: Appropriate treatment depends upon how long Focalin has been used and at what dosage, as well as the individual’s reaction to the drug and withdrawal.

 

Focalin is a central nervous system (CNS) stimulant approved by the FDA to be prescribed for the set of symptoms known as Attention Deficit Hyperactivity Disorder (ADHD). It is expected to be used as just one part of an ADHD treatment program. 

Focalin is a strong medication and its safety and efficacy have not been studied or evaluated when taken for a period longer than six weeks.

Although not as common as Adderall or Ritalin as a study drug, Focalin is used extensively. It’s very important to NOT take Focalin if you have marked anxiety, tension, and agitation. The symptoms could be made worse. 

Additionally, in order to reduce the risk of Serotonin Syndrome, it’s important to avoid Focalin and other amphetamines if you are also taking certain, very commonly used drugs such as antidepressants. It’s important to discuss this with your doctor to avoid serious repercussions before taking Focalin.

Serotonin Syndrome

There are several drugs which, in various ways, increase the levels of serotonin – a substance released in several areas of the body, including the brain. Serotonin keeps one balanced between good spirits and depression. If serotonin levels are normal, there are no negative effects.

However, when serotonin levels are too high, it can cause Serotonin Syndrome, which causes side effects. Depending on the serotonin level, the effects can be relatively mild or so severe that they can even be deadly.

The side effects/symptoms of Serotonin Syndrome include:

  • agitated emotional state
  • blood pressure fluctuations
  • body temperature fluctuations
  • confusion
  • diarrhea
  • dilated pupils
  • fever, high body temperature
  • headaches
  • increased reflexes
  • muscle coordination difficulties
  • nausea
  • rapid heartbeat
  • restlessness
  • shivering
  • sweating
  • tremors
  • vomiting

 

When the serotonin levels are very high, Serotonin Syndrome can include:

  • serious heartbeat irregularities
  • convulsions
  • unconsciousness
  • high fever
  • rhabdomyolysis – a muscle spasm complication which involves the destruction of certain types of muscles associated with various areas in the body, including skeletal muscle and heart muscle, and which can ultimately produce kidney damage.

The highest risk of Serotonin Syndrome comes when Focalin or other CNS stimulants are being used as study drugs (or for some other untested and unapproved purpose) while also taking other drugs that also raise serotonin levels.

Drugs that raise serotonin levels include antidepressants like Selective Serotonin Reuptake Inhibitors (SSRIs) – Citalopram (Celexa, Cipramil), Escitalopram (Lexapro, Cipralex), Paroxetine (Paxil, Seroxat), Fluoxetine (Prozac), Fluvoxamine (Luvox, Faverin), and Sertraline (Zoloft, Lustral) –  as well as other drugs: some painkillers, anti-anxiety drugs, bipolar medications, and even LSD.

When CNS stimulants are used as “study drugs” by someone who is already taking other serotonin-increasing drugs, Serotonin Syndrome is a high risk. And it could have fatal results.

Considering the increasing number of people with a depression diagnosis, as well as about 40 percent of anti-depressants being prescribed for off-label uses (for which they haven’t been tested or approved), like migraine, pain, insomnia, panic attacks, ‘obsessive/compulsive disorder’, and even smoking cessation, a good number of students looking to take, or already taking, ‘study drugs’ are likely taking other serotonin-increasing drugs at the same time.

The result is too much serotonin and, possibly, Serotonin Syndrome.

 

The high potential for abuse is reflected in an FDA black box warning on the Focalin label.

 

Focalin has a high potential for addiction and dependence as well as abuse. It is especially dangerous for someone who already has a drug or alcohol dependence history, but the danger extends to those without such a history as well.

Here is the black box warning on the label:

DRUG DEPENDENCE:

Focalin should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral [by injection] abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

HALF LIFE AND METABOLISM

The half-life of Focalin is just over 3 hours in healthy adults and varies between 2 and 4.5 hours. With some people, the half life may be between 5 and 7 hours. Children tend to have slightly shorter half-lives with means of 2 – 3 hours.

Focalin is primarily metabolized by de-esterification to d-ritalinic acid. 

 

Focalin has many side effects. Some are mild, some are severe. They include: 

  • allergic reactions – serious allergic symptoms can include difficulty breathing, swelling of the face, neck and throat, rashes and hives, and fever
  • abdominal pain
  • abnormal liver function, ranging from elevation of transaminase (a blood test that, if elevated, may indicate liver damage) to severe liver injury
  • aggressive behavior
  • angina 
  • anorexia 
  • arrhythmia – the heart beat is too fast, too slow, or irregular
  • arthralgia- pain in the joints
  • blood pressure increased or decreased – can sometimes get dangerously high causing severe headache, ringing in the ears, chest pain, and numbness
  • blurred vision or other visual changes
  • cerebral arteritis and/or occlusion (blockage of blood vessels) – inflammation of the blood vessel wall, involving the brain and occasionally the spinal cord. It can lead to rupture of the arteries and smaller blood vessels, resulting in stroke, headache and impairment of brain function.
  • confusion
  • dizziness
  • drowsiness
  • dry mouth
  • dyskinesia – abnormal or impaired voluntary movement
  • erythema multiforme with histopathological findings of necrotizing vasculitis – an often painful or itchy skin disease with bull’s eye pattern rashes or lesions, possibly including mouth ulcers, fever and generally feeling ill. It is usually associated with an infection or medication. It can be mild or severe. The more severe types can be life-threatening. Necrotizing vasculitis is an inflammation of blood vessel walls, usually small and medium blood vessels. This inflammation can interrupt your normal blood flow. It results in skin and muscle damage, including necrosis (the death of tissues and organs.)
  • exfoliative dermatitis – a serious skin condition manifested as redness and peeling of the skin over large areas of the body
  • eyesight changes or blurred vision
  • fast or uneven heart rate
  • feeling restless, anxious, or jittery
  • fever
  • headache
  • hypersensitivity reactions including skin rash, angioedema and anaphylaxis (an acute allergic reaction that prompts the immune system to respond.) The symptoms can include: fainting, lightheadedness, low blood pressure, dizziness, or flushing.
  • insomnia
  • leukopenia and/or anemia – a decrease in white or red blood cells
  • libido changes
  • loss of appetite
  • nausea
  • nervousness
  • neuroleptic malignant syndrome (NMS)  – NMS is usually a reaction to antipsychotic drugs. The symptoms of NMS are fever, altered mental status, muscle rigidity, and autonomic dysfunction (which includes symptoms such as dizziness and fainting upon standing up (or orthostatic hypotension), an inability to alter heart rate with exercise, or exercise intolerance).
  • palpitations – a noticeably rapid, strong, or irregular heartbeat due to agitation, exertion, or illness
  • priapism – painful and prolonged erections in children and adults. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
  • pulse increased or decreased
  • rhabdomyolysis – destruction of certain types of muscles in various areas of the body, including skeletal muscle and heart muscle.
  • scalp hair loss
  • seizures/convulsions, mainly, but not exclusively, in patients with a history of seizures
  • sleep problems (insomnia)
  • slowing of growth (height and weight) in children
  • sore throat
  • stomach ache
  • tachycardia
  • thrombocytopenic purpura
  • Tourette’s syndrome
  • toxic psychosis
  • transient depressed mood
  • twitching (described as motor or vocal tics)
  • unusual behavior
  • upset stomach
  • urticaria – a rash of very itchy round, red welts on the skin. It is sometimes accompanied by dangerous swelling and is generally an allergic reaction.
  • weight loss

 

WITHDRAWAL SYMPTOMS

Withdrawal symptoms may be mild of severe depending on how long you’ve been taking Focalin and at what dosage. When someone takes Focalin in high doses and for an extended period of time, the withdrawal symptoms can be severe enough to cause the person to go back on the drug for relief. Symptoms include:

  • body pains 
  • changes in heart rhythm
  • extreme fatigue
  • headaches
  • insomnia
  • priapism – abnormally sustained or frequent and painful erections, in both adults and children
  • severe depression
  • unusual behavior

 

Quitting Focalin on your own – usually by gradually decreasing the dosage if you’ve been taking them for an extended period of time rather than once or twice – is not usually life threatening. However, it should still be done under medical supervision. Also, if the withdrawal symptoms are too uncomfortable, distressing, painful or even dangerous to successfully become drug-free without more help, a medically-controlled detox may be in order. Call us for more information.