FDA Approves Chewable ‘Ritalin’ for ADHD Treatment

January 8, 2016

The U.S. Food and Drug Administration approved a chewable form of methylphenidate, the active ingredient in Ritalin, called QuilliChew ER to treat patients ages six and older with attention-deficit/hyperactivity disorder.

Pharmaceutical manufacturer Pfizer received approval to market the drug called QuilliChew ER two years after Quillivant XR, an extended release liquid containing methylphenidate for ADHD patients older than five, was approved.

Adults and children with ADHD struggle to pay attention or are much more active than their peers. Most symptoms occur during preschool or early years of elementary school. Most of the time, ADHD symptoms decrease as people age, but some adults do suffer from ADHD, according to the National Institute on Drug Abuse.

The FDA required Pfizer to warn about QuilliChew’s high potential for abuse on the drug’s label. Ritalin and other stimulants like Adderall, used to treat ADHD symptoms, have caused an increasing number of emergency department visits in recent years.

QuilliChew ER’s label warns that severe symptoms of stimulant abuse include anxiety, psychosis, hostility and suicidal or homicidal thoughts.

The drug’s label also warns that people who take QuilliChew ER may become tolerant to the drug, meaning the drug’s effects may be less drastic the longer someone takes it. Dependence can also occur if people take QuilliChew ER for long periods of time. Withdrawal symptoms from stimulant dependence include fatigue, insomnia, agitation and increased appetite, according to the drug’s label.

QuilliChew ER will be sold in 20-, 30- and 40-milligram doses, and patients should not take more than 60 milligrams in one day, according to Pfizer. QuilliChew ER will give doctors an additional treatment option for patients with ADHD, but like other ADHD medications, doctors should prescribe the drug with caution.

ADHD Diagnoses, Prescriptions Soar in Recent Years

Doctors have diagnosed children and adults with ADHD at increasing rates during the last decade. From 2003 to 2011, childhood ADHD diagnoses rose from 4.4 million to 6.4 million, according to the Centers for Disease Control and Prevention.

The increase in ADHD diagnoses and prescriptions for ADHD medications have made the drugs more easily available for abuse as well. More than half of college-aged adults get ADHD medications from friends or family for free, and another 17 percent buy them from someone close to them, according to SAMHSA.

Many students take the drugs to increase focus and to help them learn, but studies indicate ADHD medications don’t enhance learning when taken by people without ADHD. People who abuse the drugs also have lower high school and college GPAs, according to NIDA.

Abusing ADHD medications increases the likelihood of addiction, and in some cases rehabilitation is the only way to for people to recover. However, when taken as prescribed, ADHD medications can help people with ADHD function.

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View Sources

• Centers for Disease Control and Prevention. (2014, December 10). Key Findings: Trends in the Parent-Report of Health Care Provider-Diagnosis and Medication Treatment for ADHD: United States, 2003—2011. Retrieved from http://www.cdc.gov/ncbddd/adhd/features/key-findings-adhd72013.html
• Gever, J. (2015, December 7). Chewable Stimulant Ok’d for ADHD. Retrieved from http://www.medpagetoday.com/Neurology/ADHD-ADD/55072?isalert=1&uun=g947102d4711R7879559u&xid=NL_breakingnews_2015-12-07
• National Institute on Drug Abuse. (2014, January). DrugFacts: Stimulant ADHD Medications: Methylphenidate and Amphetamines. Retrieved from http://www.drugabuse.gov/publications/drugfacts/stimulant-adhd-medications-methylphenidate-amphetamines
• Pfizer. (2015). QuilliChew ER Labeling. Retrieved from http://labeling.pfizer.com/ShowLabeling.aspx?id=2577
• Substance Abuse and Mental Health Services Administration. (2013). Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits. Retrieved from http://www.samhsa.gov/data/sites/default/files/DAWN2k11ED/DAWN2k11ED/DAWN2k11ED.pdf
• Substance Abuse and Mental Health Services Adminsitration. (2013, January 24). Emergency Department Visits Involving Attention Deficit/Hyperactivity Disorder Stimulant Medications. Retrieved from http://www.samhsa.gov/data/sites/default/files/DAWN073/DAWN073/sr073-ADD-ADHD-medications.htm
• U.S. Food and Drug Administration. (n.d.). Methylin Chewable Tables. Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21475_methylin_lbl.pdf

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