Hydrocodone and the FDA: a Similar Propensity to Be Abused

Control Levels May Affect Sales


What does hydrocodone and the FDA have in common?  Answer:  A similar propensity to be abused.   A recent concern raised by analysts about the viability of patients to choose, with their physicians’ blessings, hydrocodone as a combination drug to solve their medicinal needs has been raised by Fitch.   Fitch Ratings Inc. is a jointly owned subsidiary of  Hearst Corporation and FIMALAC SA.

Fitch’s analysis of the effect of new FDA rules to raise the control levels for hydrocodone prescriptions shows that sales could be significantly affected, as consumers choose not to fight their insurance’s standard policy regarding the appropriateness of hydrocodone in their insured’s pain management routine.

The FDA proposes raising the Drug Enforcement Administration (DEA) control level, which could slow sales as the regulations effectively reclassify products containing hydrocodone to Schedule II from Schedule III drugs.  The goal of the FDA is to make it more difficult for users to get hooked on the drug, and to receive hydrocodone only when medically necessary.

The response of the FDA to the real issue of addiction to hydrocodone when misused is admirable.  The World Health Organization Ladder cites their standards for effective pain management in this way:

“When pain persists or increases, an opioid such as codeine or hydrocodone should be added (not substituted) to the NSAID. Opioids at this step are often administered in fixed dose combinations with acetaminophen or aspirin because this combination provides additive analgesia. Fixed combination products may be limited by the content of acetaminophen or NSAID, which may produce dose-related toxicity. When higher doses of opioid are necessary, the third step is used. At this step separate dosage forms of the opioid and non-opioid analgesic should be used to avoid exceeding maximally recommended doses of acetaminophen or NSAID.”

NSAID is an non-steriodal anti-inflammatory drug for mild to moderate pain.  It is only when the pain surpasses this and becomes more persistent that the World Health Organization recommends using opioids, such as hydrocodone.

The way in which hydrocodone has been classically abused is when the tablets are crushed, increasing the high and preventing its time-releasing effects to occur.  The abuser gets a mighty high that feels so good to them, that they continue to mash the pills into powder form.  In this way the hydrocodone user gets addicted to the medicine, and like most addictions, develops a tolerance for the drug.

It would appear that pharmaceutical companies could be greatly affected by the FDA’s proposed regulation, as it discourages the medical consumer from taking a drug that will be limited in its supply.  Patients are now allowed to refill prescriptions five times during a period of six months.

The proposed FDA rules would allow patients a maximum three month supply, but after that, patients would be required to revisit their doctor to obtain new prescriptions.  Like other controlled substances, the patient would most likely have to bring a physical prescription form after each three-month period.

To make matters more complicated, the FDA, under considerable fire from its opponents,  said Friday it approved the extended-release pill Zohydro ER for those whose pain requires “daily, around-the-clock, long-term treatment” that cannot be treated with other drugs.

Patient advocates were up in arms.  “We’re just going to kill more kids and then the FDA is going to come back and say, ‘oh, we made a mistake,'” said Avi Israel of Buffalo, N.Y.   Michael, Israel’s son, died by suicide in 2011.  He was struggling with his addiction. Israel founded the group called, Save the Michaels of the World, whose goal is to battle painkiller abuse in young people.

Hydrocodone will continue to be abused as long as it is produced and on the market.  The FDA will also tend to be abused by consumers and physicians who foresee hurdles in front of them when taking or prescribing hydrocodone.  The most likely sustained result of raising the requirements for hydrocodone users and abusers will be less pills bought and taken.  It is yet to see whether such a decrease in sales will harm the economy more than those who rely on it for pain management.


By Lisa M Pickering


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