Senators & Panel Question FDA Approval of OxyContin For Kids

Susanne Posel (OC) : The Food and Drug Administration (FDA) has voted down a proposal by Purdue Pharma to allow OxyContin to be used for previously off-label use 32 to 1 against the drug.

OxyContin_opioids_SP_OCHowever, this vote is just a non-binding recommendation to the FDA and not a final decision on the matter.

According to the panelists at the FDA, the patented delay release formulation of the drug “poses a safety risk”.

And because of OxyContin’s history as a highly abused drug, the experts said patients would be swayed not to “follow instructions to take the drug on an empty stomach” and could “wind up taking multiple doses if they don’t get the prompt pain relief they expect.”

Independent Senator Angus King has called for an investigation into the approval of OxyContin by the FDA for use with pediatric patients.

King and other like-minded senators voiced concern that “the FDA’s decision will exacerbate” drug addiction problems and called the decision tantamount to opening “the gateway to inappropriate prescribing.”

The senator said: “Studies have shown that children are particularly vulnerable to drug dependency and abuse, and that drugs can affect both mental and physical development as well as behavior.”

Last August, Prude Pharma had OxyContin approved by the FDA for children as young as 11 to treat pain.

The FDA “requested” that Prude “ perform studies evaluating safety and other important information about oxycodone and OxyContin when used in pediatric patients” in order to support new uses of OxyContin in patients ages 11 to 16.

Before the FDA approved OxyContin for children, it was used off-label for addiction in teenagers.

In 2012, Purdue began paying doctors across the nation to document the outcomes of OxyContin used to treat children in pseudo-clinical trials.

Purdue patented OxyContin in 1996 as another pain medication to add to their array of other drugs such as:

• Hydromorphone
• Oxycodone
• Fentanyl
• Codeine
• Hydrocodone

This patent was granted because of a time-release additive, regardless of the fact that this opioid-based drug was not traditionally used for painful conditions in the past.

In order to change public perception of OxyContin, Purdue recruited 5,000 physicians, pharmacists and nurses to be well-paid speakers for the corporation.

These spokespeople were armed with coupons offering free 7 – 30 day trials which became a favorite with physicians.

This scheme assisted Purdue in earning $1 billion in OxyContin sales in 2001.

However, this practice quickly became a point of abuse when doctors began over-prescribing the drug. In fact, by 2003, OxyContin accounted for 50% of prescriptions written by primary care physicians in the US.

By 2004, Purdue had reported $2.8 billion in OxyContin sales.

Susanne Posel, Occupy Corporatism

Source Article from http://nsnbc.me/2015/09/11/senators-panel-question-fda-approval-of-oxycontin-for-kids/

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