Tuesday, February 10, 2009

5 Reasons Why FDA's Furious Over Narcotics Misuse

The US Food and Drug Administration recently announced that it was beefing up efforts to curb unsafe use of 24 narcotics products used as pharmaceutical drugs. In its first such measure the regulator sent 16 companies making these products letters, asking them to have a "Risk Evaluation and Mitigation Strategy (REMS)," in place.

Narcotic products have a chemical composition that simulates the effects of naturally occurring opiates like the opium poppy, and are often prescribed to cancer patients for managing sudden and severe bouts of pain. Though these products have been in use for years now, the question is, why the FDA has come out railing against these prescription drugs?

At least five reasons are the triggers behind the FDA getting tough.

1. Widespread Use: The drugs targeted by the FDA are the most extensively prescribed and used medications. Going by the 2007 figures, pharmacies in the United States doled out about 21 million prescriptions for these 24 narcotic products, and were consumed by approximately 3.7 million Americans.

2. Ineffective Earlier Measures: The FDA was aware of the havoc these chemicals were causing and it did try to reign in on them by means of mandatory label warnings and by working together with other federal agencies. However, the problems seem to have had no effect, and instances of drug misuse, abuse and accidental overdoses have increased over the past decade.

3. Increasing Non-medical Use: The Substance Abuse & Mental Health Services Administration (SAMHSA) data shows that non-medical use of prescription pain relief drugs in Americans 18-25 has increased from 4.1% in 2002 to 4.6% in 2007. And for those aged 26 & Over, the increase has been from 1.6% from 1.3% over the same period.

4. The Products' Addictive Power: The products included in FDA's present hit list are those, which are based on extended-release formulas for long-lasting effects. But despite their efficacy in damping severe pain they carry the risk of being highly addictive. And this makes them perfect candidates for abuse, and they often are abused for their euphoric effects.

5. The FDA is now Empowered to Act!: This isn't quite a reason inherent in unsafe use of drugs, but it still is the necessary condition for the FDA action. It was only in 2007, that the USFDA got the power to require risk-management plans. Otherwise it would still have been negotiating changes to drug labeling and promotion with the drug making companies from the medical industry.

Hopefully, the new measures will harness the beast of prescription drug abuse.

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