Children’s Meds Causing Dangerous Allergic Reactions

Recently I was doing research for a client whose child had suffered an adverse reaction after taking a common children’s medication. That’s why this article in Reuters caught my attention.

It tells the story of a Massachusetts family that nearly lost their daughter due to an allergic reaction to a common household medicine. Seven year-old Samantha Reckis lost approximately 90 percent of her skin, suffered mild brain damage and is legally blind after taking children’s Motrin.

Following a decade-long trial, a Massachusetts jury has ordered Johnson & Johnson to pay $63 million to Samantha and her family.

Toxic Epidermal Necrolysis

The active ingredient in Children’s Motrin and Children’s Advil (ibuprofen) can cause an allergic reaction that burns the skin and can leave the child blind. Samantha suffered from a rare reaction to the Motrin known as Toxic Epidermal Necrolysis (TEN).

The U.S. National Library of Medicine website has some helpful information on Toxic Epidermal Necrolysis. It is listed as an extreme skin disorder that is caused by an allergic reaction. Like in Samantha’s case, the allergic reaction is usually triggered by certain medications.

Rare…But Known Danger

Although the extreme allergic reaction is rare, the manufacturer, Johnson and Johnson, knew about this possible dangerous reaction to their product but they didn’t provide any warning to consumers on their product labels.

Non-disclosure the Norm?

Pharmaceutical companies have long known about the risk of Toxic Epidermal Necrolysis as a reaction to ibuprofen. Why then did they not label their products to indicate this risk? Or provide advice on the labels for users who develop TEN symptoms? Is it because pointing out these serious side-effects might decrease their sales?

I have previously posted about other pharmaceutical companies who have been sued as a result of them not-warning customers of known and dangerous risks.

In that previous post, I discuss the lawsuits against Pfizer alleging that they failed to warn users of the risks to unborn children. Again, it is alleged that Pfizer knew of the risks and chose not to disclose all of the information.

A Silver Lining

There is some good news that may have come out of this tragic story. Since poor Samantha Reckis’ unfortunate incident, the FDA and Health Canada have ordered the manufactures of Motrin and Advil to put additional disclosure warning of the dangers of TEN on their medicine labels.