The Food and Drug Administration (FDA) is warning health care professionals that Strattera, a drug for attention deficit hyperactivity disorder (ADHD) in adults and children, could cause severe liver injury in patients. The warning, which is being added to Strattera labels at the FDA's request, comes after two people faced liver damage after taking the drug for several months.

More than 2 million people have used Strattera since it hit the market in 2002. In past clinical trials involving 6,000 patients, no signal for liver problems were reported.

The bolded warning indicates that, in a small percentage of patients, severe liver injury may progress to liver failure resulting in death or the need for a liver transplant. It's also noted that the actual number of severe liver injury cases associated with Strattera are unknown because of under-reporting of adverse events.

Patients who develop jaundice (yellowing of the skin or whites of the eyes) or laboratory evidence of liver injury should stop taking the medication, according to the warning.

Eli Lilly, Strattera's maker, plans to alert health care professionals to the potential dangers of the drug and is updating the package insert to include signs and symptoms of liver problems. These include:

• Pruritus (Itchy skin)
• Jaundice
• Dark urine
• Upper right-sided abdominal tenderness
• Unexplained "flu-like" symptoms

Medical News Today December 18, 2004

Dr. Mercola's Comments:

Last summer, I wrote an article about a growing trend: Adults being diagnosed with attention deficit hyperactivity disorder (ADHD), and that there is only one ADHD pill -- Eli Lilly's Strattera -- approved by the FDA to treat adults. Drugmaker Eli Lilly's plan to warn people with jaundice or laboratory evidence of liver injury to stop taking Strattera is a good PR move for Lilly, considering the avalanche of bad news when Merck pulled Vioxx from the market in 2004. For the record, as it says in the article 2 million people have used Strattera since it was approved, and Lilly claims none of the 6,000 patients who took it during clinical trials showed evidence of liver damage. Why do adults or kids need these drugs in the first place? One quote from a drug executive says it all: "The adult market is three times the size of the children's market. The market is ripe and is moving in the right direction." And is it surprising that drugs for attention disorders bring in $2.2 billion a year, even before the market has finished "moving in the right direction"? It doesn't make sense to risk liver damage with Strattera when, in my practice, I've found many people with ADHD have improved greatly without drugs by taking these simple steps: Eliminate grains and sugars from your diet Replace soft drinks, fruit juices and pasteurized milk with clean water Increase your omega-3 fats by taking fish or cod liver oil Related Articles: Non-Drug Treatment of ADD/ADHD Seven Percent of U.S. Grade School Kids Have ADD/ADHD Does Your Child Have ADHD? Consider Fish Oil Over Ritalin Strep Infection Possibly Linked To Attention-Deficit Disorder Autism, ADD/ADHD, and Related Disorders - Is a Common Childbirth Practice to Blame? Spending Time with Nature, a Natural Remedy for ADHD