Tag Archives: oxycontin

Quick Hits: Americans Open to Non-Drug Pain Treatments, Psychiatric Drugs’ Impact on Cognition & More

More than three-quarters of Americans — 78% — say they are willing to try non-drug alternatives for pain before turning to prescription painkillers. Results from the Gallup-Palmer College of Chiropractic Annual Study of Americans show that 40% of Americans consider prescription painkillers such as opioids a “crisis” or “very serious problem.” And 55% of those who know about the nation’s opioid epidemic place some of blame on the drug industry’s encouraging physicians to prescribe opioids. Another 53% place a lot of blame on doctors overprescribing painkillers to patients. About 23% of those polled said prescription pain meds such as opioids are not very safe, and 8% said opioids are not safe at all. In 2015, more than two-thirds of the opioid deaths reported involved prescription opioids such as oxycodone, hydrocodone, morphine and fentanyl. Posted Sept. 13, 2017. Via Gallup.

Taking high doses of antipsychotic drugs over an extended period may be associated with poorer cognition in schizophrenia. However, taking low doses of antipsychotics such as benzodiazepines and antidepressants over a long time doesn’t affect cognition, according to a new study published in the journal European Psychiatry. The research also found that schizophrenia patients who took a long break from using antipsychotic drugs tended to see their cognitive function improve. Posted Sept. 5, 2017. Via EurekAlert/European Psychiatry.

Women who take antiepileptic drugs (AEDs) during pregnancy have a higher risk of having premature babies or babies that have a low birth weight for their age in the womb. Women with epilepsy who took AEDs while pregnant had a 9.3% increased risk of having a premature baby, while women without epilepsy who took an AED had a 10.5% increased risk, according to results published in the Annals of Neurology. Women who did not take a medication and didn’t have epilepsy had only a 6.2% increased risk of a premature baby. Compared to women who didn’t take an AED and didn’t have epilepsy, women with epilepsy who took one of the drugs gave birth to a child with a mean lower birth weight of 3.9 ounces. For women who took an AED and didn’t have epilepsy, the figure was 4.8 ounces. Common AEDs include Lamictal (lamotrigine), Topamax (topiramate), Tegretol (carbamazepine), Keppra (levetiracetam) and Neurontin (gabapentin). Posted Sept. 11, 2017. Via Medical Express/Annals of Neurology.

Gone FDA-ing

Instead of writing my blog this week, I’ve been preparing for my work at an upcoming FDA hearing on July 25.

I’ll be sitting on an FDA advisory committee reviewing a New Drug Application for an Rexista, an oxycodone extended-release tablet — an opioid painkiller — from Intellipharmaceutics Corp. This is another version of OxyContin that also has abuse-deterrent properties. Intellipharmaceuticals claims that its abuse-deterrent mechanism — if crushed for snorting or dissolved in liquid for injecting — will release a blue dye and also turn its drug into a gel that then makes it difficult to abuse. Please note that while writing for my blog I’m writing on my own account and an NOT speaking on behalf of the FDA or other organization.

My role is a consumer representative on the Drug Safety and Risk Management Advisory Committee. This is a joint meeting with the Anesthetic and Analgesics Advisory Committee.

If you’d like to watch the hearing, here is the link for the live webcast.

I’ll give a full report in my blog next week!

To entertain you in the meantime, here’s a blog about my last experience on the committee that resulted in a Opana ER, an extended-release oxymorphone and another opioid, being pulled from the US marketplace:

Weighing Risks and Benefits on an FDA Advisory Committee

And our content manager’s follow up on how the FDA acted on the committee’s concerns:
A First: FDA Calls for Opioid’s Removal from Market

For those who prefer video, here’s our MedShadow TV:
On the Inside When the FDA Assesses an Opioid Delivery Method

The Fallacy of Abuse-Deterrent Opioids

The FDA’s announcement last week that it wants Opana ER (oxymorphone), a powerful prescription opioid, pulled from the market has put painkiller abuse back in the spotlight. While writing up a story on the breaking news, I Iearned that the drug was reformulated back in 2013 into an “abuse deterrent” formulation (ADF). The tablets had a special coating so that if they were crushed, they would turn into a gel that would make it difficult to snort.

Needless to say, those safeguards weren’t sufficient, as evidenced by the many cases of people finding ways to still abuse the drug, which factored into the FDA’s decision. In fact, the agency previously said the reformulation may have actually made it easier to inject Opana ER intravenously, which is how the drug is primarily abused.

Despite Opana ER’s apparent abuse-deterrence failure, a number of other opioids on the market actually have that claim on their labeling. Many of those manufacturers have touted it as a way to demonstrate their apparent commitment to stop opioid abuse. It also allows them to sell the drugs at a higher price than other generic versions. (There are no generic versions of ADFs.)

So I wondered, might these other abuse-deterrent opioids not really live up to their name? After all, some of these drugs, like OxyContin (oxycodone), are heavily prescribed. As pharmacist Jeffrey Fudin wrote in a piece for Pharmacy Times, a quick Internet search he conducted found links to pages on how to undermine the abuse-resistant coating OxyContin contains.

No Protection Against Abuse From Ingestion

It’s also important to note that none of these drugs prevent another form of abuse – ingestion, by taking more or higher doses than prescribed orally – even though this is the most common way opioids are misused. Another problem is that too many doctors think these ADFs are less addictive than others. This may lead some doctors to overprescribe opioids.

A draft version of a report released last month by the non-profit Institute for Clinical and Economic Review (ICER) appears to confirm that the benefits of opioids in an ADF are not as big as some might think. In fact, they gave these ADFs a grade of C+ in terms of their ability to curb abuse. Although there has been a decline in OxyContin abuse since that product was reformulated, the ICER report found that as a result, abuse of other opioids increased. The group added that current version of OxyContin “may have limited impact on changing overall abuse problems.”

A new report gave abuse-deterrent formulations of opioids a grade of C+ in regards to their ability to curb abuse.

The fact of the matter is that abuse-deterrent opioids will do little to curb the epidemic currently ravaging our country. Although they make it harder to abuse, it is not impossible to do so. “In summary, abuse-deterrent opioids are not the panacea for opioid addiction that their title might suggest, given their increased cost compared to other formulations, the fact that they are not fully abuse-resistant and can be abused orally,” a New Jersey state advisory committee stated in a report released in January. The panel also warned the ADFs may cause some opioid addicts to turn to heroin and fentanyl to feed their habit.

The FDA seems to be taking notice that ADFs may not be as useful as thought. On June 13, FDA Commissioner Scott Gottlieb announced a 2-day public meeting on July 10 and 11 to discuss whether ADFs are indeed limiting abuse and what impact overall they are having on the epidemic.

Limit Use of Opioids Altogether To Curb Abuse

So, what do we do to stem the epidemic? It will need to come from a multifaceted approach. But the role of ADFs of opioids in achieving that goal has been largely overstated.

One of the best ways to tackle opioid abuse is to stem the prescribing of the drugs altogether. Studies have not demonstrated that opioids are more effective in relieving pain compared to non-opioid pain medications and nonpharmacological treatments. Also, opioids are associated with a host of cardiovascular, respiratory and gastrointestinal side effects, among others. Perhaps this is why last year, the Centers for Disease Control and Prevention came out with new opioid prescribing guidelines that call for the use of opioids only after other alternatives have been pursued.

It’s also important for doctors to realize the limits of ADFs of opioids. I was happy to read an opinion piece from William C. Becker, MD, and David A. Fiellin, MD, both of the Yale School of Medicine, in a recent issue of the New England Journal of Medicine, where they wrote that “clinicians, researchers, and policymakers should invest in alternative chronic-pain treatments and models of care.” That is sure to have a bigger impact on opioid use and abuse than abuse-deterrent opioids ever could.

A First: FDA Calls for Opioid’s Removal from Market

For the first time, the FDA is asking for the removal from the market of a prescription opioid medication over abuse concerns.

The active ingredient in the drug, Opana ER (extended release), is oxymorphone, which is closely related to morphine. The drug was reformulated in 2012 in an attempt to make it more difficult to abuse. Despite this, the FDA says it has received reports of people crushing the drug, dissolving it and then injecting it. This led to an outbreak of HIV and hepatitis C in 2015 in Southern Indiana. There are also cases of some abusers of Opana ER contracting a serious blood disorder.

The FDA said it made its decision because of “its concern that the benefits of the drug may no longer outweigh its risks.” In March, an FDA advisory committee voted 18-8 agreeing with that position.

In a statement, Endo said it is reviewing the request and is considering its options. The company maintains that Opana ER “has a favorable risk-benefit profile when used as intended in appropriate patients.”

If Endo does not pull Opana ER from the market, the FDA says it will begin a process that will remove the drug’s approval.

Feeling Anxious? Depressed? Check Your Meds

If you find yourself feeling on edge for no apparent reason while taking a cold medicine or diuretic, you most likely wouldn’t connect the two. However, anxiety happens to be just one of many mood-altering symptoms that can be brought on by certain meds.

“Many medications, whether prescribed or found over the counter, can cause psychiatric symptoms,” says Shiyun Kim, PharmD, BCACP, BCPP, CDE, a clinical pharmacist and clinical assistant professor at the University of Illinois Hospital & Health Sciences System, and a spokesperson for the American Pharmacists Association.

She explains that a wide range of factors influence the way a drug affects each person, including things like metabolism, underlying illness, and interactions with other drugs. “Any variations that occur, such as with improper doses or individual reactions, can result in undesirable psychiatric symptoms,” though they are relatively uncommon.

If you feel that you may be suffering from these side effects, notify your providers immediately. “Keep in mind that some medications can be stopped abruptly, while others need to be tapered to prevent further adverse effects,” Dr. Kim emphasizes. “Your provider can make the best decision with you.”

Take note of the following medications that can have these kinds of effects, and read on to find out how to minimize the risks.

Oxycontin and Similar Pain Medications

“Most prescription pain medication, such as oxycodone (OxyContin) or hydrocodone, can cause drowsiness, which can make one feel ‘cloudy’ and lack motivation — and these symptoms closely mimic depression,” according to Bree Meinzer, PharmD, CTTS, a pharmacy practice resident at Ohio Northern University. Opioids can also lead to more severe symptoms like paranoia, hallucinations, psychosis and dementia, especially at high doses. Signs that you may have taken too much of an opioid include trouble breathing and unconsciousness. People with opioid dependence and those who suffer from HIV, liver or lung disease or suffer from depression may be more susceptible to these effects, according to the World Health Organization. If you are on a pain medication that makes you drowsy or “cloudy” and you do not like how it makes you feel, you should talk to your doctor about other ways to adequately manage your pain.

Lasix, Microzide and Other Diuretics

Medications that reduce fluid retention and swelling, including furosemide (Lasix) and hydrochlorothiazide (Microzide), increase urination. This can lead to dehydration, especially in the elderly, and can result in hallucinations and dizziness, says Dr. Meinzer. SGLT2 inhibitors such as canagliflozin (Invokana) and empagliflozin (Jardiance), which are drugs used to treat diabetes, can also increase urination and cause dehydration. If you are taking these types of medication, be sure to drink plenty of water to stay sufficiently hydrated. The amount of water to drink should be discussed with your doctor and is dependent on your weight. “These medications should also be taken in the morning or early afternoon to avoid frequent urination at night,” which could disrupt sleep, she advises.

Ask your doctor to take a look at your current medication regimen to rule out potential drug-drug interactions that could cause psychiatric side effects.

Requip and Other Dopamine Agonists. Medications like ropinirole (Requip), often prescribed for restless leg syndrome and Parkinson’s disease, increase the brain chemical dopamine, which helps regulate mood and behavior. Too much dopamine can cause hallucinations, notes Dr. Meinzer, and more extreme potential side effects include confusion, mania, depression and impulse control disorders like compulsive gambling or eating. “There are other options for restless leg syndrome that don’t increase dopamine, though medications like ropinirole typically work best.” There are also different medications for Parkinson’s, though you and your doctor should carefully consider your particular treatment needs. If you experience these kinds of symptoms while taking this type of medication, it may be that your dose is too high.

Ritalin, Adderall and Other Stimulants

Drugs that are commonly used for the treatment of attention-deficit hyperactivity disorder (ADHD) include those sold under the brand names Ritalin and Adderall. Although these stimulant medications “help children and adolescents focus and stay on task, side effects include increased heart rate and insomnia, which can often cause anxiety and restlessness,” says Dr. Meinzer. Stimulants “excite the central nervous system and can disrupt normal communication between cells in the brain,” adds Dr. Kim. “This class of drugs may also cause bizarre behavior, agitation, mania, paranoia and nightmares.” Dr. Meinzer suggests talking to your healthcare provider if you feel extremely restless and anxious while taking this type of medication. Again, it is possible that your dose is simply too high.

Corticosteroids

Medications like prednisone, cortisone and methylprednisolone are often prescribed “to help respiratory symptoms and decrease inflammation with chronic diseases,” Dr Meinzer explains. They are typically only “used for a short term to help alleviate symptoms, but if you are on these medications for a long time, they can cause some unwanted side effects.” Use of these drugs for more than a few months can increase the chances of experiencing mania, anxiety, depression, paranoia and psychosis, which have mostly been reported by patients using high doses or abusing the medication, says Dr Kim. Though experts are unclear about the exact reasons for such side effects with these drugs, research suggests that it may have to do with the way steroids work in the area of the brain that influences memory and emotion. It is also possible that “high levels of steroids result in brain damage and cause cognitive dysfunction.”

Zarontin and Other Anticonvulsants

Medications such as ethosuximide (Zarontin), which are used to control seizures in people with epilepsy, can cause symptoms resembling depression. These drugs have also been found to increase suicidal thoughts and behavior. “If you start to experience these symptoms on an anticonvulsant, you should talk to your doctor about other regimens,” Dr. Meinzer recommends. “There are other medications in the same class that are less likely to cause this side effect,” though your doctor may want you to stay on the medication because it may be the one that is most effective for you. “Anticonvulsants are usually tricky to dose and may need lab monitoring to make sure they are in the proper range.”

Dr. Kim offers the following general tips to help prevent or deal with these side effects:

  • When you are prescribed a drug, ask your provider about potential side effects that are commonly noted and reported.
  • Ask your provider to take a look at your current medication regimen to rule out potential drug-drug interactions that could cause psychiatric side effects.
  • Withdrawal of some drugs can cause symptoms such as anxiety, agitation or depression. Therefore, call your doctor before stopping medications on your own.
  • When purchasing an over-the-counter (OTC) medication, take the time to read the instructions on the package. If anything is unclear, ask the pharmacist for guidance.

Opioids No Better Than OTC Analgesics for Serious Pain After Accident

Taking a prescription opioid or a common over-the-counter analgesic are equally effective at controlling pain after a serious accident, though those on opioids are likely to remain on those drugs for a longer period of time.

Researchers examined the prescribing patterns and pain experience over 6 weeks by 948 people who were involved in car accidents that were taken to the ER and then released.

The risk of pain was no different whether patients took opioids, such as the highly addictive and often abused OxyContin, or NSAIDs Advil (ibuprofen) or Aleve. However, those who were initially given opioids were 17.5% more likely to still be taking the drug after 6 weeks, the researchers reported in the journal Pain.

“These results suggest that analgesic choice at [ER] discharge does not influence the development of persistent moderate to severe…pain 6 weeks after a [motor vehicle collision], but may result in continued use of prescription opioids,” the researchers wrote.

‘My Drug Dealer Was a Doctor’

Grammy-award-winning hip hop artist Macklemore has released a song that is a pointed indictment of the medical and pharmaceutical industry, and takes a kick at Congress too.

The song describes the US medical system as one where patients are misled about the safety of medicines, doctors prescribe pills such as Ambien, Adderall, Xanax and Percocet because “Big Pharma” pays them to, and says that those drugs lead to dependency, addiction, harder drugs and death.

Macklemore has been public about his own struggles with drugs and alcohol. He has said he experimented with OxyContin, the opioid painkiller at the center of a national epidemic, when he was younger. Macklemore described his addiction to OxyContin to MTV News as “synthetic heroin.”

Why should you, I or “Big Pharma” care what Macklemore says in a hip-hop song? It has more than 6.3 million views on YouTube since being released on October 25. You can’t buy enough ads to counter those impressions.

The refrain of the song illustrates well how drug companies influence doctors to prescribe drugs even though they may be dangerous:

My drug dealer was a doctor, doctor

Had the plug from Big Pharma, Pharma

He said that he would heal me, heal me

But he only gave me problems, problems

My drug dealer was a doctor, doctor

Had the plug from Big Pharma, Pharma

I think he trying to kill me, kill me

He tried to kill me for a dollar, dollar

Confidence in the good intent of doctors and the pharmaceutical industry is under assault. The deaths from addictions started by prescriptions and the near-viral spread of addiction has caught the attention of this generation. Macklemore is unwilling to shoulder the blame for his generation’s addictions alone. Instead, he is pointing a finger directly at the pharmaceutical companies:

Paying out Congress so we take their drugs

Murderers who will never face the judge

I hope you share the shame I feel at the end of the song when Macklemore recites the Alcoholics Anonymous prayer as his benediction. How have so many people been harmed so much? While he’s blaming doctors for his addictions, but he’s taking responsibility for his own recovery.

There are a few bad people in every industry (we’ve all heard of “pill mills”) but I can’t bring myself to believe or agree with Macklemore’s theory that doctors write prescriptions because they are paid to and that pharma companies create drugs that addict on purpose to make more money. But it begs the question: Many lives depend on the efficacy and honesty of pharmaceutical company work. Yet as for profit companies, they have a fiduciary responsibility to make the most profit (return) for shareholders. Shouldn’t pharmaceutical companies’ mission allow and require that human health and safety come before profit? Don’t pharmaceutical companies and doctors both share in the tenet of the Hippocratic Oath, “First, do no harm”?

We need to listen to Macklemore because he’s speaking for a generation. We need to ruthlessly examine our medical system to determine any kernel of truth in the accusations of this song. And if we find any truth, we need to fix it. For Macklemore is right when he says:

But this shit’s been going on from Seattle out to South Philly

It just moved out about the city

And spread out to the ‘burbs

Now it’s everybody’s problem, got a nation on the verge