focalinsideeffects.comFocalin and Focalin XR (dextro-methylphenidate) Side Effects and Warnings

NEWS AND FACTS ABOUT MEDICINES YOU TAKE Home / methylphenidate / dextro-methylphenidate / Focalin + Focalin XR Focalin is a chemical variant of methylphenidate, dextro- or dexmethylphenidate, and also comes in an XR version. Naturally, the manufacturer claims it is better than other versions of methylphenidate, but that claim is met with skepticism by many psychopharmacologists. SOURCE: The Essential Guide to Psychiatric Drugs—Rev. and updated (2007). Focalin Side Effects and Warnings Updated November 16, 2018 Schedule II Substance Brand Names: FOCALIN, FOCALIN XR Generic Names: dextro-methylphenidate hydrochloride (HCI), dexmethylphenidate hydrochloride (HCI) Category: CEREBRAL STIMULANTS Focalin is an amphetamine-like prescription stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults. Many think Focalin is safe, or mild, because so many children use it. However, the government classifies the psychoactive drug with cocaine and morphine because it is highly addictive. U.S. DEPT. OF JUSTICE: “Of particular concern is that ADHD literature prepared for public consumption does not address the potential or actual abuse of methylphenidate. Instead, methylphenidate is routinely portrayed as a benign, mild substance that is not associated with abuse or serious side effects. In reality, however, the scientific literature indicates that methylphenidate shares the same abuse potential as other Schedule II stimulants . Further, case reports document that methylphenidate abuse can lead to tolerance and severe psychological dependence.” ABOVE: Drug Enforcement Administration, US Department of Justice. “Methylphenidate, A Background Paper,” NCJRS (National Criminal Justice Reference System) Abstract, NCJ 166349 (1995): www.ncjrs.gov/App/publications/abstract.aspx?ID=163349 . FDA “Black Box” Warning Label The Food and Drug Administration (FDA) requires the following "black box" warning on all methylphenidate drugs, which means that medical studies indicate methylphenidate drugs carry a significant risk of serious, or even life-threatening, adverse effects. WARNING FOCALIN-XR IS A FEDERALLY CONTROLLED SUBSTANCE (CII) BECAUSE IT CAN BE ABUSED OR LEAD TO DEPENDENCE. KEEP FOCALIN-XR IN A SAFE PLACE TO PREVENT MISUSE AND ABUSE. SELLING OR GIVING AWAY FOCALIN-XR MAY HARM OTHERS, AND IS AGAINST THE LAW. TELL YOUR DOCTOR IF YOU OR YOUR CHILD HAVE (OR HAVE A FAMILY HISTORY OF) EVER ABUSED OR BEEN DEPENDENT ON ALCOHOL, PRESCRIPTION MEDICINES OR STREET DRUGS. ABOVE: FDA black box warning label means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. The bold warning label appears on the manufacturer's wholesale packaging and is the strongest alert the FDA can require of drug-makers. Used For Attention deficit disorder Narcolepsy How Focalin Works We don't know exactly why it produces the effects it does. Methylphenidate was first synthesized in 1944 in an (unsuccessful) attempt to create a stimulant that would not induce addiction or tolerance. Focalin, a methylphenidate drug, is very closely related to amphetamine : similar in chemical structure, metabolization and clinical effects. This close connection is the chief reason methylphenidate drug use raises concern among patients and others. "Physiological effects of oral cocaine and methylphenidate were similar." ABOVE: Rush, C.R., et al. "Behavioral pharmacological similarities between methylphenidate and cocaine in cocaine abusers," Exp. Clin. Psychopharmacol : Feb;9(1):59-73(2001): www.ncbi.nlm.nih.gov/pubmed/11519636 . Do Not Use If You have high blood pressure or any form of heart disease, are very nervous or have severe insomnia, have a history of addiction to drugs or alcohol. FOCALIN and FOCALIN XR should not be taken if you or your child: are very anxious, tense, or agitated have an eye problem called glaucoma have tics or Tourette's syndrome, or a family history of Tourette's syndrome. (Tics are hard to control repeated movements or sounds.) are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. are allergic to anything in FOCALIN XR. The manufacturer also warns: "FOCALIN XR [and FOCALIN] should not be used in children less than 6 years old because it has not been studied in this age group." Common Side Effects Addiction Nervousness including agitation, anxiety and irritability Trouble sleeping (insomnia) Decreased appetite Headache Stomach ache Nausea Dizziness Heart palpitations Other Serious Side Effects Include slowing of growth (height and weight) in children seizures, mainly in patients with a history of seizures eyesight changes or blurred vision Less Common Side Effects High blood pressure Rapid pulse rate (and other heart problems) Tolerance (constant need to raise the dose) Feelings of suspicion and paranoia Visual hallucinations (seeing things that are not there) Depression Cocaine craving Dermatoses (infected or diseased skin) Urinary tract infection Infection or viral infection Elevated ALT enzyme levels in the blood (signaling liver damage) FDA Warning: Links Between ADHD Drugs and Priapism and Sexual Dysfunction In a recent drug-safety announcement, the FDA announced that drugs containing methylphenidate must including warnings about the risk of priapism. (Methylphenidate drugs include: Concerta, Daytrana, Focalin, Metadate, Methylin, Quillivant, and Ritalin.) It's a serious problem: priapism is a persistent, usually painful, erection that lasts for more than four hours and occurs without sexual stimulation. If the condition is not treated immediately, it can lead to scarring and permanent erectile dysfunction. The FDA included an even stronger warning about atomoxetine (Strattera): “Priapism appears to be more common in patients taking atomoxetine than in patients taking methylphenidate products. Health care professionals should be cautious when considering changing patients from methylphenidate to atomoxetine.” The safety warning also raised concerns about links between priapism and amphetamine drugs, which include Adderall, Dexedrine, ProCentra and Vyvanse. ABOVE: U.S. FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes. (12/17/2013). Overdose Side Effects Methylphenidate drugs have been extensively abused. Extreme psychological dependence and severe social disability have resulted. Abuse of methylphenidate drugs may cause a sudden heart attack even in those with no signs of heart disease. Symptoms of overdose that require immediate medical assistance include: Restlessness Tremor Aggression Hallucinations Panic states Hyperreflexia (overactive reflexes, which can include twitching or spasms) Personality changes Symptoms of depression Seizures or abnormal EEGs High blood pressure Rapid heart beat Swelling of hands/feet/ankles (for example, numbing of the fingertips) Delusions Sweating Vomiting Dehydration Unexplained muscle pain Lower abdominal pain Rhabdomyolysis and kidney damage Chronic abuse can manifest itself as psychosis, often indistinguishable from schizophrenia What to Do About Side Effects The last dose of the drug every day should be taken several hours before bedtime to prevent insomnia. Nervousness usually goes away and appetite often returns so that weight loss is rarely dangerous. If high blood pressure, rapid pulse, paranoia, or tolerance becomes a problem, the drug is usually stopped. Nothing can be done about the addiction except to remember not to stop taking any version of methylphenidate abruptly. Focalin and Focalin XR are Schedule II Substances, which means Focalin and Focalin XR have a "high potential for abuse" that "may lead to severe psychological or physical dependence," and the federal government sets limits on the amount of these drugs that may be manufactured e...