Dear Patients and Consumers:
Shire circulated two versions of a video featuring celebrity spokesperson Ty Pennington sharing his experience with taking Adderall XR for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) that the U.S. Food and Drug Administration (FDA) found to be false or misleading. These videos were the topic of a Warning Letter (the Letter) from the FDA in September 2008.
These videos appeared on the internet through YouTube.com and www.adderallxr.com. The FDA stated that the videos were misleading because they overstated the effectiveness of Adderall XR by implying that the product will transform patients’ lives, improve their confidence, help with communication difficulties, and help them to fit in and to not feel different or alienated. Shire would like you to know that Adderall XR has not been studied to determine its impact on any of these types of behaviors and feelings.
The Adderall XR webpage entitled "Difficulties caused by ADHD in adolescence" was also addressed by FDA in the Letter. This webpage listed some of the consequences of untreated ADHD in teens (including poor social-emotional development and job success, inability to complete schooling, illegal behaviors, contraction of sexually transmitted diseases, motor vehicle accidents, and physical injury), and implied that Adderall XR may have an effect on these consequences. Shire would like you to know that Adderall XR has not been shown to have a positive impact on any of these consequences.
Furthermore, FDA stated in the Letter that the website suggested that Adderall XR treatment is effective for a behavior disorder called "conduct disorder." Adderall XR is not approved to treat conduct disorder, which is a distinct disorder from ADHD.
In clinical studies, Adderall XR has been found effective at treating the core symptoms of ADHD of inattentiveness (focus), hyperactivity (being fidgety), and impulsivity (for example frequently interrupting others) in children aged 6 to 12, adolescents aged 13 to 17, and adults.
The Letter also noted that the video posting on YouTube.com provided several effectiveness claims for Adderall XR, but did not include the appropriate risk information associated with the use of the drug. Shire would like to provide to you this Important Safety Information:
ADDERALL XR® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Tell your doctor about any heart conditions, including heart problems, heart defects, or high blood pressure, that you, your child, or a family member, may have. Inform your doctor immediately if you or your child develop symptoms that suggest heart problems, such as chest pain or fainting. Adderall XR may cause sudden death in patients who have heart problems or heart defects, stroke or heart attack in adults, and increased blood pressure and heart rate.
Adderall XR should not be taken by patients who have hardening of the arteries (arteriosclerosis); heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; are very anxious, tense, or agitated; taking or taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell your doctor before using Adderall XR if you or your child are being treated for or have symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; have abnormal thought or visions, hear abnormal sounds, or have been diagnosed with psychosis; have had seizures or abnormal EEGs; have or have had high blood pressure; exhibit aggressive behavior or hostility. Tell your doctor immediately if any of these conditions or symptoms develop while using Adderall XR. Aggression, new abnormal thoughts/behaviors, and mania have been associated with the use of drugs of this type.
Adderall XR (an amphetamine) is a federally controlled substance (CII) because it can be abused or lead to dependence. Misuse of Adderall XR may cause sudden death and serious heart adverse events.
Talk to your healthcare provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked often while taking Adderall XR. Your healthcare provider may stop Adderall XR treatment if a problem is found during these check-ups.
Worsening of motion or verbal tics and Tourette’s syndrome have been associated with use of drugs of this type. Tell your doctor if you or your child has blurred vision while taking Adderall XR.
Tell your doctor if you or your child take other drugs known as sympathomimetics (for example, cold or allergy medicines that contain decongestants).
Adderall XR was generally well tolerated in clinical studies. The most common side effects in studies included: children - decreased appetite, trouble sleeping, stomachache, and mood swings; adolescents - loss of appetite, trouble sleeping, stomachache, and weight loss; adults - dry mouth, loss of appetite, trouble sleeping, headache, and weight loss.
For further information on Adderall XR, please see Full Prescribing Information, including Medication Guide.
If you have any questions about Adderall XR, please contact Shire Medical Information at 1-800-828-2088.
Sincerely,
Michael Yasick
Senior Vice President
ADHD Business Unit Lead
Shire Pharmaceuticals Inc.