Before Vioxx Was Pulled From the Market the FDA Approved it For Kids!

<<< Back to Vaccines

Vioxx, the painkiller drug responsible for 30,000 to 100,000 cardiovascular-related health risks, was approved for children only weeks before it was pulled from the market.

With the outstanding negative side-effects found in adults using Vioxx, such as heart attack and stroke, many wonder why the drug had been approved for children, or at all for that matter.

However, with over 300,000 children in the United States suffering from some form of rheumatoid disease, very few drug treatments exists. In fact, this may be the reason why the FDA and other researchers were initially on board with Vioxx, failing to ask questions concerning its safety.

The only other approved drug available for children suffering from juvenile arthritis is Enbrel, which is known to trigger rare complications such as lymphoma, a cancer of the lymphatic system.

As early as 1999, both Merck and the FDA had strong hints about the cardiovascular risks associated with the drug. Merck's "wonder drug" was turning out to be anything but a wonder.

Many Merck critics claim the company had plenty of warning signs, yet continued advertising for the drug regardless. Despite concerns, the company proceeded with the pediatric test, which lasted a mere three months, and sent the drug on its way to thousands of suffering children.

One spokeswoman for Merck claims that information about heart risks were printed on the label. According to studies, the label being referred to is the fine-print package insert, which is rarely read.

One FDA researcher found evidence of cardiovascular disorders associated with Vioxx use. Before the drug was approved for children, he reported his findings at a medical conference. However, FDA officials ignored the study, stating it was not considered the "gold-standard" by the pharmaceutical industry. Thus, the evidence was not strong enough to deter approval for pediatric use.

The FDA remains unapologetic for the decision they made concerning Vioxx, in that the correct decision was made based on the information they were given. The agency also agrees that pulling the drug from the market was the right thing to do.

Newsday October 11, 2004.

Washington Post October 18, 2004.

Back to top of Document