After recommendations from the FDA, the makers of Adderall XR have upgraded the drug’s black-box label. The “black-box” section of prescription drug labeling is where the most serious side effects of drugs must be listed. Adderall XR is the best-selling prescription drug for the treatment of attention-deficit hyperactivity disorder (ADHD). The FDA urged all manufacturers of ADHD drugs to warn patients that these products may cause psychological side effects including psychosis, bipolar illness and aggression. Misuse or abuse of ADHD drugs can also cause serious cardiovascular side effects such as heart attack, stroke and sudden cardiac death. On August 21, 2006, Shire PLC announced it would add language to include warnings that misuse of Adderall XR could lead to sudden death.

An estimated five million people use ADHD drugs in the U.S., with over three million users under 19 years old. Adderall XR was pulled from the prescription drug market in Canada in February 2005 after 20 patient deaths were reported, but it was returned to the market in August of that year. In May 2006, Health Canada, the oversight agency similar to the U.S. FDA, strengthened Adderall XR’s warning label for patients in Canada.

Source: Shannon Pettypiece and Justin Blum, “Glaxo, Shire Strengthen Risk Warnings on ADHD Drugs,” Bloomberg.com, August 21, 2006.

The US Food and Drug Administration updated its Public Health Advisory today after Health Canada ordered a suspension of marketing of Adderall and Adderall XR products in the Canadian market. Marketing was halted due to concerns about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR.

SUD has been associated with amphetamine abuse, and reported in children with underlying cardiac abnormalities taking recommended doses of medications containing amphetamines. Adderall and Adderall XR contain amphetamines. Health Canada has received reports of a number of cases of SUD reported in children on Adderall without structural cardiac abnormalities. The FDA warned that it could not conclude at this time that Adderall causes SUD, but is continuing to evaluate data on this drug. The reported cases of SUD included one case that reported above-toxic blood levels of amphetamine.

Alliant Pharmaceuticals issued a nationwide recall on January 14, 2005 of about 2800 bottles of the drug Methylin, used to treat attention deficit hyperactivity disorder, also known as ADHD, and narcolepsy. The lot number, AMT50402A, has an expiration date of April 2006 and may contain as much as three times the active ingredient it should.

The company sent letters to doctors and pharmacists to ask them to notify patients who may have received a dispensation of the drug from a provider with bottles from the defective lot.

If you have any questions about a prescription dose of Methylin you may have recently received, you are advised to speak with your pharmacist or medical doctor immediately. It is not advised to stop taking any prescription medication without the advice of a physician.

Eli Lilly and Company has added a safety warning to the labels of its drug Strattera warning people with jaundice or laboratory evidence of liver injury (hepatotoxicity) not to take the drug. Lilly is notifying doctors of the labeling change after two people taking the medication, indicated for attention-deficit disorder, suffered severe liver damage. Severe liver damage may progress to liver failure, resulting in death or the need for liver transplantation.

Strattera is primarily prescribed for adults as well as patients younger than 18 who have been diagnosed with attention-deficit/hyperactivity disorder, or ADHD. Strattera competes with the Johnson & Johnson drug Concerta and Novartis AG’s Ritalin. Symptoms of ADHD include lack of attention and concentration, or impulsive behavior. Over 2 million people have used Strattera since the FDA approved it for ADHD in November of 2002.

Initial signs of liver damage, or hepatotoxicity, include:

• Itchy skin, called pruritus
• Jaundice
• Dark urine
• Tenderness on the upper-right side of the abdomen
• Flu-like symptoms

Source: Associated Press, “Strattera warning limited,” December 21, 2004; “Lilly announces Important Liver Safety Update to Strattera Label,” Medical News Today, December 19, 2004.

The U.S. Food and Drug Administration has issued an advisory to health officials concerning the drug Strattera. Straterra is given to children and adults diagnosed with attention deficit hyperactivity disorder (ADHD). The label on the drug is being updated with a bolded warning about the potential for severe liver injury. The label warns that severe liver injury may lead to liver failure resulting in death or the need for a liver transplant. The label also mentions that the number of actual cases of severe liver injury may be higher than previously thought, due to under-reporting.

The warning states that patients taking the medication who develop jaundice (yellowing of the skin or whites of the eyes) should stop taking Strattera. The FDA asked the manufacturer, Eli Lilly, to add the warnings. Eli Lilly will also update the patient package insert with information about the signs and symptoms of liver damage, which include:

• Pruritus (itchy skin)
• Jaundice
• Dark urine
• Upper right-sided abdominal tenderness
• Unexplained “flu-like” symptoms

Alliant Pharmaceuticals expanded its nationwide recall of Methylin Chewable Tablets to cover all lots of the drug. Methylin is prescribed to treat attention deficit hyperactivity disorder, also known as ADHD. Methylin is also prescribed to treat narcolepsy. Further investigation by the manufacturer, Malinckrodt, Inc., of St. Louis, MO, found that tablets of all dosage strengths may contain as much as three times the amount of active ingredient necessary.

The drug maker blamed the problem on a mixing issue. The recalled medication came in 100-tablet bottles with the following lot numbers:

2.5-mg dose

• AMT20401A
• AMT20402A
• AMT20403A
• AMT20404A

5-mg dose

• AMT50401A
• AMT50402A
• AMT50403A
• AMT50404A

10-mg dose

• AMT100401A
• AMT100402A
• AMT100403A
• AMT100404A

Alliant said fewer than half of the approximately 10,000 bottles manufactured have been distributed. Alliant is sending letters to wholesalers and pharmacists to quarantine any bottles that match the above lot numbers and notify patients who received the prescription. More information can be obtained by calling Alliant at 1-770-817-4500 between 8 am and 5pm EST, Monday through Friday.