From the editor ...
According to the article, when a little girl was seven years old her parents gave her Children's Motrin for a fever. She apparently received three doses over 24 hours, but the article did not go into further detail. All we know is that shortly after taking the Motrin she started to experience symptoms the paper called a "severe reaction" that doctors diagnosed as toxic epidermal necrolysis (TENS).
Toxic epidermal necrolysis is a rare, potentially deadly skin condition. Usually the cause is drug-related reaction, but there are other causes and often the cause isn't found.
The girl suffered a lot from her TENS--she lost most of her skin, developed permanent lung and liver damage and blindness. She had multiple complications, surgeries, hospitalizations and other issues. She needs special care and will never be able to get a driver's license. Now 16, she is doing well in school and has plans to attend college.
The family sued Johnson & Johnson and won a $65 million settlement. It's not final as it needs to be approved by the judge and the manufacturer will undoubtedly appeal. It will probably be years before the case is finalized.
This is a case where no one really wins. The girl's life is altered forever. She will continue to suffer as long as she lives. The money she receives--$50 mil-lion--is an enormous sum, but it will never make her completely healthy. Her parents, now divorced, each received $6.5 million. If properly managed, neither will ever have financial concerns. But they will always have guilt because they gave her the medicine.
Similarly, the manufacturer loses. Insurance will probably cover the money, but, if the verdicts holds up, it may affect their sales, insurance costs and reputation.
Lastly, society loses. A case like this reinforces the "jackpot" mentality that permeates our society. Parents may shy away from a generally safe treatment because of out-of-proportion fears of dangers it may pose to their children.
This case raises a number of questions. One is how far should a drug company go with its warnings? TENS is a very rare condition, but should every drug contain a list of every possible reaction? Currently the common reactions are listed. Since any drug may cause any reaction is the any one person, there's no reliable way to list all the potential reactions. The warnings list, often refered to as the package insert, of prescription drugs is quite detailed and can be scary.
Second, do the warnings make much difference to most people? Rarely does anyone read the entire package insert. If everyone did, many fewer drugs would be taken.
Would a parent not give a febrile child a product because of the warnings? I suspect most parents think that if a drug is sold without a prescription, is labelled as being for children and is used by so many kids for so long then it must be safe. And generally they are right. The over-the-counter medicines are very safe. But in rare cases that doctors, manufacturers, and parents can't foretell, medicines can be harmful.
Another question, rarely addressed, is if the medicine is really necessary. Again, I don't know the details of this situation. However, many doctors now recommend against treating a fever unless it's making the child very uncomfortable. The easiest way to prevent an adverse drug reaction is to not take the drug at all, so parents need to seriously consider if their child's ailment warrants taking medicine.
You could say there's a risk-to-benefit ratio for just about anything we do. Most of the time we don't consciously think about it and carefully weigh the pros and cons of what we do. When making health-related decisions for you or your children it is important to consider the risk-to-benefit ratio. It could make the difference between health and sickness, or even life and death.
Richard J. Sagall, MD
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|Title Annotation:||drug warning labels|
|Author:||Sagall, Richard J.|
|Publication:||Pediatrics for Parents|
|Date:||Jul 1, 2012|
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