Painkillers For Kids: Recent FDA Approval Marks The Latest Step In OxyContin’s Evolution

Painkillers For Kids OxyContin Approved - Summit EstateThe United States has been embroiled in an opioid overdose epidemic for years, resulting in growing public support for stricter prescription practices and more oversight of pharmaceutical manufacturers. One of the most potent opioid painkillers on the market is OxyContin, and that name has been part of the public drug discussion for the past couple of decades for many reasons.

Although OxyContin is one of the most effective medications for treating severe pain for long periods of time, it is also one of the most habit-forming prescription drugs. Last year, the Food and Drug Administration (FDA) approved OxyContin for use for children as young as 11 years old. OxyContin is an incredibly potent and highly habit-forming opioid, and this new approval has drawn no small amount of scrutiny.

For years, OxyContin had only been prescribed to treat chronic and severe pain. The deciding factor for whether the drug can be given to a child is a bit ominous as well: The child must be able to tolerate a 20 mg opioid dose over five consecutive days to qualify for continued use of OxyContin.

OxyContin is a long-acting painkiller that can provide relief for up to 12 hours for even the most serious pain, and pediatric healthcare professionals have argued that this can help ease the suffering of children with terminal or seriously debilitating health problems.

Although the FDA’s decision is not meant to make OxyContin the first choice among opioid painkillers for children, this change has led to significant public debate. Those who support the change say the drug is powerful enough to combat even the most severe pain some children face, namely from cancer or serious invasive surgeries, such as spinal fusions.

OxyContin In The News

OxyContin's Dubious Track Record - Summit EstateOne of the major criticisms of this new approval is that the FDA is acting in the interest of the pharmaceutical company that develops OxyContin: Purdue Pharma. Purdue has a poor public perception, mostly due to the fact it pled guilty in 2007 to charges of misbranding and misleading pharmaceutical regulators about OxyContin’s potential for abuse and risk of addiction.

Purdue aggressively marketed OxyContin after its introduction in 1996. Sales of the drug reached $1 billion that first year, and Purdue was criticized for marketing to general practitioners and other health care professionals that typically are not trained to identify patterns of abuse among patients.

By the year 2000, abuse and crime rates surrounding OxyContin skyrocketed, as the drug is capable of producing a high as powerful as that of heroin. One of the main reasons Purdue has been criticized was that during the course of legal proceedings, internal documents surfaced that proved the manufacturer was well aware of OxyContin’s potential for abuse and addictive properties.

The time-release nature of the drug was inaccurately touted as a deterrent to abuse, and Purdue severely underreported the appearance of withdrawal symptoms in arthritis patients. These are notoriously serious offenses, and it would appear to many that, at least at the time, Purdue was far more concerned with profits than public welfare.

After a guilty plea, Purdue was forced to pay $600 million in criminal and civil penalties – $130 million of which went to civil litigation settlements for patients. Since the incident, OxyContin has been met with no short supply of scrutiny, although American opioid prescription rates have continued to climb.

America’s History With Painkillers

19000 Deaths Prescription Opioid Overdose 2014 - Summit EstatePrescription opioids are some of the most commonly prescribed painkillers in the U.S., despite the fact drug overdose is the leading cause of accidental death in the country. Opioid addiction is the major driving force behind this very serious epidemic. Of the more than 47,000 lethal drug overdoses in 2014, nearly 19,000 were attributed to prescription opioids. Additionally, heroin (an illicit opioid) caused more than 10,000 overdose deaths that year.

One of the biggest issues with the prescription opioid epidemic in the U.S. is that it increases heroin use among the population. Prescription opioids are addictive and carry a high risk for abuse. Without careful, thoughtful instructions, patients can easily overdose or develop dependency. Once their prescription runs out, many patients see heroin as an attractive substitute. This is because “smack” is cheaper than black market opioid pills and far more accessible.

Building A Tolerance

Despite the addictive nature of opioid painkillers, prescription use has continued to climb over the past several decades. Unfortunately, the nature of prescribed medication lends itself to misuse. Many patients simply assume that since their doctors prescribed the medicine, it must be safe to use. Once the drug works itself into the body, one may develop a slight tolerance to the drug, and it may not treat their pain as effectively after some time. Some patients assume it is safe to up their dosage a bit to compensate for their newfound tolerance..

This line of reasoning turns a slight tolerance into a major tolerance, and patients often go through their prescriptions much faster than intended due to their painkillers lessening in potency. By the time they require so much of the drug that addiction has set in, they essentially depend on the opiod to function.

Recent Strides To Combat Abuse

To combat abuse, Purdue recently reformulated OxyContin pills so they could not be as easily crushed into powder. OxyContin abusers would commonly crush the pills so they could snort the powder or mix it into a solution for injecting. Both methods produce a much more potent and faster-acting high than simply ingesting the pills. Hence, Purdue Pharma’s new formula has helped curb overall demand for black market OxyContin.

However, while this change helps to actively curb OxyContin abuse, the new formula is a double-edged sword. If doctors believe the potential for abuse has been diminished with the new formula, they may be more liberal in giving prescriptions to patients. This, in turn, could further the prescription opioid epidemic we are seeing today and create more addicts.

OxyContin’s Evolution: Now Available To Adolescents

OxyContin Can Help Children With Cancer Sickle Cell Anemia - Summit EstateThe important thing to remember is that most addicts do not actively choose to abuse their prescriptions. Many are people with legitimate health problems and a genuine need for opioid painkillers who have simply disregarded their doctors’ instructions or were not thoroughly informed about the risks of their prescriptions before obtaining them.

It is an unfortunate reality in our world that children sometimes must contend with life-threatening and incredibly painful health issues too. The recent FDA ruling is aimed at providing these children with an effective pain-management drug formerly reserved strictly for emergency situations at a doctor’s discretion. The ruling is also meant to provide long-term pain relief for conditions that cannot be adequately managed with other, less potent medications.

Purdue has repeatedly insisted that it has no plans whatsoever for active OxyContin marketing to pediatricians, and the company remains committed to opposing and preventing abuse and misuse of the drug. As an additional safety measure, the FDA has required that Purdue perform consistent follow-up studies on how OxyContin is used among younger patients. This is meant to immediately identify any troubling patterns as they emerge.

The FDA has also required that Purdue collate and report nationally representative data concerning OxyContin prescriptions for children under the age of 17. This data must include the conditions it is being prescribed to treat and the types of doctors providing the prescriptions. These additional requirements are meant to be safeguards to ensure OxyContin is used appropriately for minors.

Clearer Directions For Physicians

The FDA has argued that this change was not meant to make OxyContin more available or more widely used, but rather to better educate the health care industry about how to safely use and distribute opioid painkillers in pediatric cases. Doctors are legally permitted to prescribe and administer whatever medications they deem fit for any given scenario, and the FDA claims that this change will provide a better standard of care for children who are fighting serious medical issues.

The new labeling and dosage changes make it much easier for health care professionals to determine which adolescent patients need OxyContin, and it eliminates most of the guesswork about proper dosage. Children that could greatly benefit from this form of consistent pain relief are those who are:

  • Facing aggressive forms of cancer
  • Recovering from invasive surgeries
  • Stricken with sickle cell anemia or another potentially fatal condition

This issue has sparked vehement voices on both sides of the debate. Many of the strongest supporters are pediatricians, pain specialists and parents that all too often have to witness children in severe pain firsthand. Detractors voice their concerns that this change is made in favor of Purdue’s profits and puts children at an unnecessary risk for addiction. The current opioid overdose epidemic certainly has a large part to play in these raised concerns, too.

Patterns Of Addiction In Adolescents

Another major point of contention is that adolescents are more predisposed to forming addictions than adults. Since the adolescent brain is not fully developed, it is much easier to develop addictive patterns and a dependence on an opiate painkiller. Indeed, prescription opioids are responsible for tens of thousands of accidental deaths each year, and it has been widely argued that the FDA’s ruling opens the doors to children being a larger portion of those statistics.

Recent studies have shown that drug abuse among adolescents and teens has declined to the lowest levels seen in years. This trend has continued despite the ongoing national opioid epidemic, so it would be difficult to draw a connection between this new ruling and OxyContin abuse among adolescents. Another safeguard preventing younger patients from forming addictions is the fact children are rarely responsible for their prescriptions.

Parents are most likely the ones to dispense their kids’ medication, and the new FDA ruling specifically requires careful instructions to be included for all adolescent prescriptions. If parents are properly warned about proper dosing and the dangers of addiction present with OxyContin use, adolescent patients will be less likely to develop addiction to the drug and will use them only as intended.

It would seem that though today’s youth are far warier of drug abuse than previous generations. The known effects of drugs, the consequences of addiction, and the fear of legal repercussions are effective deterrents for keeping children disinterested in experimenting with hard drugs.

Time Will Tell If Painkillers For Kids Is The Right Decision

OxyContin For Kids FDA Approval Opioid Epidemic - Summit EstateAt this point, it is difficult to say definitively one way or another if this change is a step in the right direction. The new ruling requires stricter instructions for use and follow-up studies to carefully analyze the effects of OxyContin prescriptions among adolescents, and it aims to curb the opioid epidemic through responsible use. Children who suffer from serious pain are also now afforded a great degree of relief through OxyContin prescriptions.

On the other hand, the opioid epidemic does not seem to be diminishing, and this new ruling could very well result in a spike in youth opioid dependency. However, one must keep in mind that adolescents are not in charge of their medical treatment and prescriptions. They rely on their doctors and parents for treating and managing their conditions.

As long as those individuals have been thoroughly informed about the dangers of opioid addiction and abuse, it stands to reason that there is little reason to fear the FDA’s decision as a dangerous one.

Will Prescriptions Rise?

As stated previously, one detail that will remain to be seen for some time is whether this change and the new perception of OxyContin will result in an increase in prescriptions overall. If doctors are more confident in the efficacy and safety of the drug, then they will naturally be more inclined to prescribe it without reservation.

One of the most important things to keep in mind is that this new ruling is focused on thorough and accurate labeling as well as education for health care professionals about proper prescription practices, safe applications and appropriate doses. With any luck, this new change will highlight the appropriate applications of OxyContin for all patients so they can benefit and experience an enhanced quality of life while dealing with their afflictions.

By thoroughly educating the health care industry and all relevant professionals about the proper applications of this drug, the FDA may actually help curb the current opioid overdose epidemic rather than prolong it.