Have you ever asked your doctor, “Are you sure this drug is safe for my child?” Like millions of other parents, you rely on your doctor’s advice about the decisions you make for your child’s health.
Abbot Laboratories Inc. recently pulled a drug that affects children and adults alike. On the market for more than 30 years, doctors prescribe Cylert for attention deficit and hyperactivity disorder, (ADHD).
So why pull a successful drug? And why did the FDA remain silent for 30 years? Take a few moments to read today’s Health Alert and I’ll share with you what I’ve discovered.
Cylert received approval from the FDA in 1975. The first signs of danger – liver toxicity – came in clinical trials before its approval.(1) Since, the FDA received 206 reports of liver toxicity attributed to Cylert. Remember that in general 10% of harmful drug side effects are reported to the FDA. Thirteen people had liver failure, 11 died or needed a liver transplant.(2)
A study from 1995 shows that when taking the generic form of Cylert, your child’s risk of liver failure is 45 times greater.(3) The FDA’s answer to this disturbing report? They put a warning label on the box. The FDA later concluded that, “labeling changes had no effect on compliance.” Meanwhile cases of liver toxicity continue to climb.
In 1999, a six-year-old child suffered liver failure and ended up in the hospital. All the while, Abbot Laboratories was unable to prove that Cylert was any more effective than safer treatments already on the market.
Elsewhere in the world, other countries started to ban the sale of Cylert. The first was the United Kingdom in 1997. Canada followed in 1999.
Now last month, Abbot Laboratories decided to suspend sales of Cylert. There has still been no action by the FDA.
Most commonly, ADHD is a complex social and behavioral problem with many environmental causes. Our fast-paced world, poor diet, social changes, the disintegration of the extended family, excessive TV and video games are all pieces of the puzzle. Taking drugs, however, will never provide a long-term solution. Especially when doctors assure parents that unsafe drugs are safe and the FDA takes no action to stop the practice even when the drugs prove deadly.
In my own practice, a lack of focus or attention is usually a symptom of behavior issues – not ADHD. In some instances – maybe 3% of the time – a physiological problem causes an attention deficit or hyperactivity. Changes in diet or allergy tests will usually reveal the problem in these cases.
To Your Good Health,
Al Sears, MD
1 Gilbert, JG, Donnelly KJ, et al., “Effect of Magnesium Permoline and Methylphenidate on Memorty Improvement and Mood in Normal Aging Subjects, International Journal of Aging and Human Development, 1973;4:35-51.
Tolman KG, Freston JW, et al., Hepatotoxicity Due to Permoline. Report of Two Cases, Digestion, 1973;9(6):532-9
2 Pizzuti D, Dear Dr Letter, Cylert. Abbott Laboratories, Abbot Park, IL, Dec, 1996
3 Berkovitch M, Pope E, et al., Permoline-Associated Fulminant Liver Failure: Testing the Evidence for Causation, Clinical Pharmacology & Therapeutics, 1995;57:696-98