Metadate ER FDA Alerts

The FDA Alerts below may be specifically about Metadate ER or relate to a group or class of drugs which include Metadate ER.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Metadate ER

FDA Updating Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD and Other Conditions

May 11, 2023 | Audience: Health Care Professionals, Patients, Caregivers

What safety concern is FDA announcing?

To address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants, the U.S. Food and Drug Administration (FDA) is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines. The current prescribing information for some prescription stimulants does not provide up to date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers. Further, individuals who are prescribed stimulants are often faced with requests to share their medication. Sharing these medicines with others can lead to development of substance use disorder and addiction in those with whom these drugs are shared.

Prescription stimulants can be an important treatment option for disorders for which they are indicated. However, even when prescribed to treat an indicated disorder, their use can lead to misuse or abuse. Misuse and abuse, also called nonmedical use, can include taking your own medicine differently than prescribed or using someone else’s medicine. For this reason, sharing prescription stimulants with those for whom they are not prescribed is an important concern and a major contributor to nonmedical use and addiction. Misuse and abuse of prescription stimulants can result in overdose and death, and this risk is increased with higher doses or unapproved methods of taking the medicine such as snorting or injecting.

What is FDA doing?

We are requiring the Boxed Warning, FDA’s most prominent warning, to be updated and we are adding other information to the prescribing information for all prescription stimulants. We are adding information that patients should never share their prescription stimulants with anyone, and the Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class. The Boxed Warning also will advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Information on these risks is being required in several sections of the prescribing information, including the Warnings and Precautions, Drug Abuse and Dependence, Overdosage, and Patient Counseling sections. We are also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

What is a prescription stimulant and how can it help me?

Prescription stimulants are used to treat attention deficit/hyperactivity disorder (ADHD), binge-eating disorder, and uncontrollable episodes of deep sleep called narcolepsy. Prescription stimulants may help decrease impulsivity and hyperactivity, and increase attention in patients with ADHD; help reduce the number of excessive overeating episodes in patients with binge-eating disorder; and help promote wakefulness in patients with narcolepsy. These medicines have benefits when used appropriately, but they also have serious risks, including the risk of misuse and abuse, addiction, overdose, and death. Examples of common prescription stimulants include Adderall (amphetamine/dextroamphetamine), Concerta (methylphenidate), Dexedrine (dextroamphetamine), and Ritalin (methylphenidate).

What should health care professionals do?

Assess patient risk of misuse, abuse, and addiction before prescribing stimulant medicines. Counsel patients not to share their prescribed stimulant with anyone else. Educate patients and their families on these serious risks, proper storage of the medicine, and proper disposal of any unused medicine. Throughout treatment, regularly assess and monitor them for signs and symptoms of nonmedical use, addiction, and potential diversion, which may be evidenced by more frequent renewal requests than warranted by the prescribed dosage.

What should patients and caregivers do?

Always take your prescription stimulant exactly as prescribed by your health care professional. Do not take more of the medicine or take it more often than prescribed. Never provide any of your prescription stimulant medicine to anyone else as it can have serious risks for those for whom it was not prescribed. Store your prescription stimulant medicines securely, out of sight and reach of children and in a location not accessible by others, including visitors to the home. Immediately dispose of unused or expired prescription stimulants properly or take them to a drug take-back site, location, or program. Talk to your health care professional if your use of prescription stimulants has resulted in problems with your health, relationships, responsibilities, or the law, or if you are struggling with misusing these or other medicines. Go to an emergency room or call 911 if you experience symptoms of stimulant overdose, including new tremors or change in existing tremors, seizures, restless or aggressive behavior, overactive reflexes, fast breathing, fast or irregular pulse rate, confusion, stomach cramps, or more serious symptoms such as heart attack or stroke. Talk to your health care professional if you have questions or concerns about risks of taking prescription stimulants.

What did FDA find?

We reviewed the medical literature published from January 2006 to May 2020 on misuse and abuse, also called nonmedical use, of prescription stimulants and associated adverse events. Overall, the most common source of prescription stimulants for nonmedical use in the general population came from friends or family members, with estimates generally ranging from 56 percent to 80 percent, usually provided for free. Nonmedical use from their own prescription accounted for approximately 10 percent to 20 percent of people who report having used stimulants nonmedically in the past year. Less commonly reported sources included drug dealers or strangers accounting for 4 percent to 7 percent of people who report having used stimulants nonmedically in the past year, and the internet accounting for 1 percent to 2 percent.

Our review found that nonmedical use has remained relatively stable over the past two decades, despite the increasing number of prescription stimulants dispensed. However, the past-year prevalence of nonmedical use of these medicines varies across specific subpopulations and is highest in the following groups: young adults ages 18 to 25 (estimates ranged from 4.1 percent to 7.5 percent), college students (4.3 percent), and adolescents and young adults diagnosed with ADHD (estimates ranged from 14 percent to 32 percent). According to the available data, people who use prescription stimulants for nonmedical reasons have a higher risk of developing a substance use disorder than those who do not. The most serious harms were more commonly observed with nonmedical use by a non-oral route such as snorting or injecting.

What is my risk?

All medicines have side effects even when used correctly as prescribed. It is important to know that people respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors. As a result, we cannot determine how likely it is that someone will experience these side effects when taking prescription stimulants. However, it is harmful to take prescription stimulants or other medicines in ways other than exactly as prescribed by your health care professional. Talk to your health care professional if you have questions or concerns about the risks of taking prescription stimulant medicines.

How do I report side effects from prescription stimulants?

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving prescription stimulants or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

How can I get new safety information on medicines I’m prescribing or taking?

You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of interest to you.

Table of Prescription Stimulant Label changes

Key Prescription Stimulant Label Updates (PDF - 236KB)

Facts about Prescription Stimulants

Prescription stimulants can help patients: with ADHD stay focused longer, listen better, and fidget less; with a binge-eating disorder, reduce the number of excessive overeating episodes; and with narcolepsy, stay awake during the day.
Prescription stimulants also carry serious risks, including misuse and abuse, substance abuse disorder and addiction, overdose, and death.
There are two main categories of prescription stimulants: immediate-release and extended-release. Immediate-release stimulants are usually taken two or three times a day, and extended-release stimulants are taken once a day.
Prescription stimulants are available in many different formulations, including tablets, capsules, and liquid form.
Common side effects of prescription stimulants include loss of appetite, trouble sleeping, headache, stomachache, irritability, fast heart rate, and high blood pressure.
Store your prescription stimulants securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not share these medicines with anyone else, and immediately dispose of unused or expired prescription stimulants properly or take them to a drug take-back site, location, or program.

Additional Information for Health Care Professionals

To address continuing concerns of misuse, abuse, and addiction of prescription stimulants, FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines. The current prescribing information in some prescription stimulants does not provide up to date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers. Further, individuals who are prescribed stimulants are often faced with requests to share their medication. Sharing these medicines with others can lead to development of substance use disorder and addiction in those with whom these drugs are shared.
Counsel patients not to give any of their medicine to anyone else and monitor for signs and symptoms of diversion such as requesting refills more frequently than needed. As many as half of youth with valid prescriptions for these medicines are approached by peers and other individuals in the person’s peer group to sell or give away their medicine.
Throughout treatment with prescription stimulants, regularly assess and monitor for signs and symptoms of nonmedical use and addiction.
Keep careful records of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal laws.
Educate patients and caregivers on the importance of proper storage and disposal of prescription stimulants.
Advise patients and caregivers that taking a prescription stimulant other than how it is prescribed, or together with alcohol or other controlled substances, could increase the risk of overdose and death.
Inform patients and caregivers how to recognize the signs and symptoms of an overdose.
Counsel patients that nonmedical use of prescription stimulants can cause anxiety, nervousness, loss of appetite, and sleep deprivation—all of which can interfere with studying and performance on exams.
Encourage patients to read the Medication Guide they receive with their filled prescription(s). This important information will be included, as well as additional information about the medicine.
To help FDA track safety issues with medicines, report adverse events involving prescription stimulants or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.
You can sign up for email alerts about Drug Safety Communications on medicines and medical specialties of interest to you.

Additional Information for Patients, Caregivers, and Others

To address continuing concerns of misuse, abuse, and addiction of prescription stimulants, FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines.
The current prescribing information in some prescription stimulants does not provide up to date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers. Individuals prescribed stimulants also are often faced with requests to share their medication. Sharing these medicines can lead to the development of substance use disorder and addiction in those with whom these drugs are shared.
Even when prescription stimulants are taken as prescribed by a health care professional, they can lead to misuse and abuse, also called nonmedical use, and addiction, which can lead to overdose and death.
The risk of overdose and death is increased with higher doses or when a pill is manipulated (e.g., crushed or made into a liquid form) and snorted or injected.
Take prescription stimulants exactly as your health care professional prescribes.
Do not take larger doses than prescribed.
Do not take them more frequently than prescribed.
Using prescription stimulants, which are controlled substances, without a doctor’s prescription or misusing someone else’s prescription is dangerous and is against the law.
Do not purchase prescription stimulants from dealers or illegal online sellers. Taking prescription stimulants not prescribed to you may be harmful, and illegal sellers may provide falsified products that appear to be legitimate prescription products but contain dangerous illicit drugs like fentanyl or methamphetamine, which can have fatal consequences.
Do not take prescription stimulants with alcohol or other controlled substances like opioids, if they are not prescribed for you, as this can have serious and possible deadly consequences.
Seek medical attention immediately by going to an emergency room or calling 911 if you experience serious side effects or symptoms of stimulant overdose, which can lead to a heart attack, stroke, or seizures. Symptoms may include:
- Fast heart rate
- Fast breathing
- Increased blood pressure
- Dilated pupils
- Restlessness
- Tremors
- Overactive reflexes
- Loss of coordination
- Muscle pain
- Stomach cramps
- Nausea and vomiting
- Aggressive behavior
- Panic
- Confusion
- Hallucinations
Talk to your health care professional if you have questions or concerns about the risks of taking prescription stimulants.
Many who take unprescribed prescription stimulants experience anxiety, nervousness, loss of appetite, and sleep deprivation—all of which can interfere with studying and performance on exams.
Store your prescription stimulants securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not share these medicines with anyone else, and immediately dispose of unused or expired prescription stimulants properly or take them to a drug take-back site, location, or program.
Read the patient Medication Guide that comes with your filled prescription(s). This important information will be included, and there may be additional information about your medicine. The Medication Guide explains the important things you need to know about the medicine. These include the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for when you are taking the medicine.
To help FDA track safety issues with medicines, report side effects from prescription stimulants or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.
You can sign up for email alerts about Drug Safety Communications on medicines and medical specialties of interest to you.

Background Summary

We reviewed the medical literature published from January 2006 to May 2020 on adverse events associated with misuse and abuse, also known as nonmedical use, of prescription stimulants. Our review found the most common source of prescription stimulants for nonmedical use was from family members and friends, and those in an individual’s peer group. These shared medications are usually provided for free^1,2 and are not from users’ own prescriptions, with estimates generally ranging from 56 percent to 80 percent.^3-8 In general, people use these medicines nonmedically thinking they will enhance work or academic performance,^1,2,7,9 and less commonly for recreational or social reasons.^1,2,7,9

Our review found that nonmedical use has remained relatively stable over the past two decades^9,10 despite the increasing number of prescription stimulants dispensed. Overall, the dispensing for Schedule II stimulants increased over the last three decades, almost doubling in the past 10 years from approximately 12.5 million prescriptions in the first quarter of 2011 to 20 million in the first quarter of 2022.¹¹ The prevalence of nonmedical use of prescription stimulants varies across specific subpopulations and is highest in young adults (past-year prevalence estimates ranged from 4.1 percent to 7.5 percent),^12,13 people in college (nationally representative estimate of past-year prevalence 4.3 percent),¹⁴ and people diagnosed with ADHD (past-year prevalence ranged from 14 percent to 32 percent).^15-18 Nonmedical use of prescription stimulants is most common in young adults ages 18 to 25,^12,13 and often begins in early adulthood.^19-22 In general, people who use prescription stimulants nonmedically do so infrequently, with approximately 50 percent to 75 percent reporting nonmedical use less than or equal to once a month,^19,23 although some college students reported doing so more frequently.^19,23

People who use prescription stimulants nonmedically may have a higher risk of developing a substance use disorder^24,25,26 than those who do not. Use of other substances in the past year is common among those who use prescription stimulants nonmedically.^7,23,27,28 Common substances include alcohol, marijuana, cocaine, and opioids.^7,23,27,28 Data suggest that college students who nonmedically use prescription stimulants may not perceive polysubstance use as a risky behavior.²⁹

Among those presenting with an acute adverse event related to their nonmedical use of prescription stimulants, the most severe harms are more commonly observed when the nonmedical use was by a non-oral route, as observed in data from U.S. poison centers. Among poison center cases with documentation of nonmedical use of a schedule-II prescription stimulant³⁰ from 2001 to 2018, approximately 70 percent of cases that mentioned an injection route had a related medical outcome with clinical effects that were moderate (i.e., prolonged or systemic in nature and usually requiring treatment)³¹ or major (i.e., life-threatening or resulting in significant residual disability).³² Approximately 65 percent of nasal/inhalation and approximately 56 percent of oral route cases had a related medical outcome with a moderate or major effect.

Deaths involving stimulants continue to increase and often involve multiple substances, such as opioids.³³ Deaths involving illicit stimulants or opioids outnumber deaths involving prescription stimulants.³⁴ People seeking to illegally obtain prescription stimulants from others have been exposed to greater risks in recent years because of the increasing presence of illicit sellers offering falsified prescription stimulant products that contain harmful substances such as methamphetamine or fentanyl.^35-38

References

Arria AM, Caldeira KM O’Grady KE, Vincent KB, Johnson EP, Wish ED. 2008b. Nonmedical use of prescription stimulants among college students: Associations with attention-deficit-hyperactivity disorder and polydrug use. Pharmacotherapy 28:156-169.
Advokat CD, Guidry D, Martino L. 2008. Licit and illicit use of medications for attention-deficit hyperactivity disorder in undergraduate college students. J Am Coll Health 56:601-606.
Chen LY, Strain EC, Crum RM, Storr CL, Mojtabai R. 2014. Sources of nonmedically used prescription stimulants: Differences in onset, recency and severity of misuse in population-based study. Drug Alcohol Depen 145:106-112.
Chen LY, Crum RM, Strain EC, Alexander GC, Kaufmann C, Mojtabai R. 2016. Prescriptions, nonmedical use, and emergency department visits involving prescription stimulants. J Clin Psychiatry 77:e297-304.
Compton WM, Han B, Blanco C, Johnson K, Jones CM. 2018. Prevalence and correlates of prescription stimulant use, misuse, use disorders, and motivations for misuse among adults in the United States. Am J Psychiatry 175:741-755.
Han B, Jones CM, Blanco C, Compton WM. 2017. National trends in and correlates of nonmedical use of prescription stimulants, nonmedical use frequency, and use disorders. J Clin Psychiatry 78:e1250-e1258.
Novak SP, Kroutil LA, Williams RL, Van Brunt DL. 2007. The nonmedical use of prescription ADHD medications: Results from a national internet panel. Subst Abuse Treat Prev Policy 2:32.
Saloner B, Bachhuber M, Barry CL. 2017. Physicians as a source of medications for nonmedical use: Comparison of opioid analgesic, stimulant, and sedative use in a national sample. Psychiatr Serv 68:56-62.
SAMHSA, Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, Quarters 1 and 4, 2020. NSDUH Detailed Tables: Table 1.22B. ONLINE. Available at: https://www.samhsa.gov/data/report/2020-nsduh-detailed-tables [accessed 11/15/22].
Han B, Jones CM, Blanco C, Compton WM. 2017. National trends in and correlates of nonmedical use of prescription stimulants, nonmedical use frequency, and use disorders. J Clin Psychiatry 78:e1250-e1258.
Source: FDA internal analysis using data from IQVIA, US Launch. Jan 1992 through March 2022. Data extracted June 17, 2022.
Ford JA, Pomykacz C. 2016. Non-medical use of prescription stimulants: A comparison of college students and their same-age peers who do not attend college. J Psychoactive Drugs 48:253-260.
McCabe SE, Wilens TE, Boyd CJ, Chua KP, Voepel-Lewis T, Schepis TS. 2019c. Age-specific risk of substance use disorders associated with controlled medication use and misuse subtypes in the United States. Addict Behav 90:285-293.
McCabe SE, Teter CJ, Boyd CJ, Wilens TE, Schepis TS. 2018. Sources of prescription medication misuse among young adults in the United States: The role of educational status. J Clin Psychiatry 79.
Egan TE, Dawson AE, Wymbs BT. 2017. Substance use in undergraduate students with histories of attention-deficit/hyperactivity disorder (ADHD): The role of impulsivity. Subst Use Misuse 52:1375-1386.
Holt LJ, Marut PN, Schepis TS. 2018. Pursued for their prescription: Exposure to compliance-gaining strategies predicts stimulant diversion in emerging adults. Psychol Addict Behav 32:122-131.
Holt LJ, McCarthy MD. 2020. Predictors of prescription stimulant misuse in U.S. College graduates. Subst Use Misuse 55:644-657.
Bright GM. 2008. Abuse of medications employed for the treatment of ADHD: Results from a large-scale community survey. Medscape J Med 10:111.
Arria AM, Caldeira KM, Allen HK, Bugbee BA, Vincent KB, O'Grady KE. 2017. Prevalence and incidence of drug use among college students: An 8-year longitudinal analysis. Am J Drug Alcohol Abuse 43:711-718
Bavarian N, McMullen J, Flay BR, Kodama C, Martin M, Saltz RF. 2017. A mixed-methods approach examining illicit prescription stimulant use: Findings from a northern California university. J Prim Prev 38:363-383.
Kirkpatrick ZA, Boyd CJ. 2018. Stimulant use among undergraduate nursing students. J Addict Nurs 29:84-89
Luthar et al. 2018 Luthar SS, Small PJ, Ciciolla L. 2018. Adolescents from upper middle class communities: Substance misuse and addiction across early adulthood. Dev Psychopathol 30:315-335.
Ross MM, Arria AM, Brown JP, Mullins CD, Schiffman J, Simoni-Wastila L, et al. 2018. College students' perceived benefit-to-risk tradeoffs for nonmedical use of prescription stimulants: Implications for intervention designs. Addict Behav 79:45-51.
O’Brien MS, Anthony JC. 2009. Extra-medical stimulant dependence among recent initiates. Drug Alcohol Depend 104:147-155.
McCabe SE, Veliz P, Boyd CJ. 2016c. Early exposure to stimulant medications and substance-related problems: The role of medical and nonmedical contexts. Drug Alcohol Depend 163:55-63.
McCabe SE, Veliz P, Wilens TE, Schulenberg JE. 2017. Adolescents’ prescription stimulant use and adult functional outcomes: A national prospective study. J Am Acad Child Adolesc Psychiatry 56:226-233c224.
McCabe SE, Teter CJ, Boyd CJ. 2006. Medical use, illicit use and diversion of prescription stimulant medication. J Psychoactive Drugs 38:43-56.
Sepulveda DR, Thomas LM, McCabe SE, Cranford JA, Boyd CJ, Teter CJ. 2011. Misuse of prescribed stimulant medication for ADHD and associated patterns of substance use: Preliminary analysis among college students. J Pharm Pract 24:551-560.
Parks KA, Levonyan-Radloff K, Przybyla SM, Darrow S, Muraven M, Hequembourg A. 2017. University student perceptions about the motives for and consequences of nonmedical use of prescription drugs (NMUPD). J Am Coll Health 65:457-465.
In America’s Poison Centers database, National Poison Data System, route is provided at the level of the case rather than for each involved substance. Therefore, in the assessment of routes of prescription stimulant nonmedical use, the cases were limited to those that only mentioned involvement of a prescription stimulant. Cases were further limited to those with medical outcomes that were considered related to the exposure.
America’s Poison Centers definition of Moderate Effect: The patient exhibited symptoms as a result of the exposure which are more pronounced, more prolonged or more of a systemic nature than minor symptoms. Usually, some form of treatment is or would have been indicated. Symptoms were not life-threatening, and the patient has returned to a pre-exposure state of well-being with no residual disability or disfigurement.
America’s Poison Centers definition of Major Effect: The patient has exhibited symptoms as a result of the exposure which were life-threatening or resulted in significant residual disability or disfigurement.
Hoots B, Vivolo-Kantor A, Seth P. 2020. The rise in non-fatal and fatal overdoses involving stimulants with and without opioids in the United States. Addiction 115:946-958.
Hedegaard H, Bastian BA, Trinidad JP, Spencer M, Warner M. 2018. Drugs most frequently involved in drug overdose deaths: United States, 2011-2016. Natl Vital Stat Rep 67:1-14.
Powell T. Ohio State University Warns of Fake Adderall Pills After Two Students Died in One Week. CBS News. ONLINE. Available at: https://www.cbsnews.com/news/ohio-state-university-students-dead-fake-adderall-pills/ [Accessed 11/17/2022].
United States Attorney’s Office, District of Massachusetts. Twenty-Three Individuals Charged with Trafficking Counterfeit Prescription Pills. ONLINE. Available at: https://www.justice.gov/usao-ma/pr/23-individuals-charged-trafficking-counterfeit-prescription-pills [Accessed 11/17/2022].
United States Attorney’s Office, Western District of Michigan. West Michigan Man Sentenced to 23 Years in Prison for Illegally Possessing Firearms and Intending to Sell Fake Adderall Pills. ONLINE. Available at: https://www.justice.gov/Usao-wdmi/pr/2022_0628_Wilson [Accessed 11/17/2022].
United States Drug Enforcement Administration. Public Safety Alert: Sharp Increases in Fake Prescription Pills Containing Fentanyl and Meth. ONLINE. Available at: https://www.dea.gov/alert/sharp-increase-fake-prescription-pills-containing-fentanyl-and-meth [Accessed 11/18/2022].

Related Information

Controlled Substances Program: Future public conference planning to discuss topics related to ADHD stimulants
Information about Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)
Prescription Stimulants DrugFacts
5 Myths About Stimulant Abuse
Prescription Stimulant Misuse and Prevention Among Youth and Young Adults
Drug Diversion
Disposal of Unused Medicines: What You Should Know
Lock it Up: Medicine Safety in Your Home
The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective
Think It Through: Managing the Benefits and Risks of Medicines

Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections

Dec 17, 2013 | Audience: Psychiatry, Family Medicine, Pediatrics, Consumer

ISSUE: FDA is warning that methylphenidate products (including Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR), one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism. Based on a recent review of methylphenidate products, FDA updated drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. If not treated right away, priapism can lead to permanent damage to the penis.

Priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to an abnormally long-lasting and sometimes painful erection. Another ADHD drug, Strattera (atomoxetine), has also been associated with priapism in children, teens, and adults.

Priapism appears to be more common in patients taking atomoxetine than in those taking methylphenidate products; however, because of limitations in available information, FDA does not know how often priapism occurs in patients taking either type of product.

See the FDA Drug Safety Communication for additional information, including a Data Summary.

BACKGROUND: Methylphenidate products are central nervous system (CNS) stimulants used to treat attention deficit hyperactivity disorder (ADHD).

RECOMMENDATION: Healthcare professionals should talk to male patients and their caregivers to make sure they know the signs and symptoms of priapism and stress the need for immediate medical treatment should it occur. Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs.

Encourage your patients to read the Medication Guide they receive with every filled prescription. Use caution when considering switching patients from methylphenidate to atomoxetine. Patients should not stop taking a methylphenidate product without first discussing it with your health care professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[12/17/2013 - Drug Safety Communication - FDA]

Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review

Jun 15, 2009 | Audience: Pediatricians, Neuropsychiatric healthcare professionals

Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

[06/15/2009 - Communication About An Ongoing Safety Review - FDA]
[06/15/2009 - News Release - FDA]
[06/15/2009 - Stimulant Medications Prescribing Information, Medication Guides - FDA]

Methylin CT (Methylphenidate HCl Chewable Tablets)

Jan 19, 2005 | Audience: Pharmacists, Pediatricians, Neuropsychiatric healthcare professionals[01/19/2005] FDA and Alliant Pharmaceuticals notified healthcare professionals and consumers of the voluntary recall of one lot of Methylphenidate HCl Chewable Tablets, 5 mg strength,indicated for Attention Deficit Hyperactivity Disorder and Narcolepsy. After testing and evaluation, Alliant found that lot number #AMT50402A [expiration date April 2006] might contain up to three times the active ingredient, and elected to recall the medication as it could pose serious health risk for some patients.

[UPDATE 02/10/2005] Recall expanded to include all lots of the product. The nationwide recall now includes all 2.5 mg, 5 mg and 10 mg dosage strengths because some tablets may contain too much or too little active ingredient.

[February 09, 2005 - Firm Press Release - Alliant Pharmaceuticals]
[January 14, 2005 - Firm Press Release - Alliant Pharmaceuticals]