Tag Archives: oxycontin

Sales of Black Market Opioid Prescription Drugs Soar

Black market sales of opioid prescription drugs online have significantly increased since the DEA (Drug Enforcement Administration) restricted the sales of one opioid more tightly in 2014.

More specifically, that year the DEA reclassified opioids containing hydrocodone from a Schedule III to a Schedule II drug. This new classification stopped automatic repeat prescriptions.

Hydrocodone is often combined with the analgesic acetaminophen (Tylenol) and sold under the brand name Vicodin.

Researchers analyzed whether the 2014 ruling had an effect on the trade of opioids through illegal online markets known as “cryptomarkets.” Data was pulled and examined from 31 of the world’s largest cryptomarkets operating from 2013 to 2016.

The results indicated that there was an increase in the sale of prescription opioids through US cryptomarkets after reclassification, with no statistically significant changes in sales of sedatives, steroids, stimulants or illicit opioids.

Sales of opioids through US cryptomarkets represented 13.7% of all drug sales in July 2016, compared with a modelled estimate of 6.7% of all sales had the reclassification not been introduced, researchers reported in the BMJ.

Researchers also noted that there was a change in the type of drugs purchased after reclassification. Fentanyl went from being the least-sold product to the second most popular prescription opioid bought from cryptomarket sellers based in the US. Meanwhile, hydrocodone sales dropped, while sales of oxycodone — also known under the brand name OxyContin — rose.. Currently, fentanyl is the leading cause of opioid overdoses in the US.

FDA Cracks Down on Online Sellers of Rx Opioids

The FDA is going after 9 companies operating 53 websites for allegedly hawking online unapproved and misbranded versions of opioid medications, such as oxycodone and tramadol.

The FDA has issued warning letters — which order the companies to stop selling the products immediately — to the 9 firms. The agency noted that patients who purchase these substances may be “putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe.”

The illegal online sale of prescription opioids is particularly concerning considering that oxycodone and tramadol have boxed warnings indicating they have a significant risk of serious and potentially life-threatening adverse events. These risks include addiction, abuse and breathing problems.

“The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids,” FDA Commissioner Scott Gottlieb said in a statement. “We’ll be following these actions with additional steps in coming months to crack down on the flow of illegal, unapproved opioids sold online and shipped through the mail.”

FDA Encouraging Industry to Make More Opioid Abuse Therapies

The FDA is working toward making therapies for opioid use disorder more readily accessible by advising pharmaceutical companies to limit the number of times they conduct clinical trials on particular proposed treatments.

The FDA published a draft guidance indicating that certain “depot buprenorphine products” may not require additional efficacy and safety studies in certain instances because the agency may have approved a similar product that already underwent clinical testing.

“Unfortunately, far too few people who suffer from opioid use disorder are offered an adequate chance for treatment that uses safe and effective medications,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

“The FDA will continue to encourage more widespread innovation and development of new and better treatments for opioid addiction as well as tackle the unfortunate stigma that’s sometimes associated with use of these treatments.”

On the other hand, if certain depot buprenorphine products require additional clinical testing, then drugmakers would have to show that their product is identical to the drug that has already been approved instead of proving that it is safe and effective.

The FDA will publish further guidance detailing the types of clinical outcomes that will be measured and evaluated for future treatment approvals.

Trump Opioid Plan Involves Vaccine, Death Penalty

The Trump Administration has unveiled a new opioid plan that involves developing a vaccine to combat opioid addiction. It also includes the death penalty for high-volume opioid drug pushers.

Researchers from the Walter Reed Army Institute of Research and the National Institute on Drug Abuse have developed an experimental heroin vaccine that works in mice and rats. However, it still has a long way to go until it is ready for use, as scientists are working to make it effective in humans as well.

When tested, the vaccine didn’t interfere with other opioid medications, which was pivotal because the vaccine will only be effective if it’s part of a multifaceted approach.

The vaccine will only work for a short period of time and will require repeated doses, according to Dr. John Franklin, chief of addictions in the department of psychiatry and behavioral sciences at Northwestern. If the vaccine is implemented with other opioid treatments, it could be a key factor in curbing the opioid crisis.

Quick Hits: Limiting Opioid Rxs, Accutane Defense & More

A bipartisan group of senators has introduced a bill limiting opioid prescriptions for acute pain to 3 days. Eight senators, led by Rob Portman (R-OH), have proposed the new federal law in order to curb opioid addiction, which has led to dependence on heroin and the deadly synthetic drug fentanyl. The lawmakers are looking to enforce this new rule because the 3-day opioid prescription limit is sufficient for most acute pain, according to the Centers for Disease Control and Prevention (CDC). Posted February 27, 2018. Via Sen. Rob Portman.

Defense attorneys are looking to blame the acne drug Accutane for the murder of a young woman. Last year, a 15-year-old boy was accused of stabbing a woman to death. Now, the teen’s attorneys are saying that Accutane (isotretinoin), which is an acne treatment that has been linked to unstable behavior, may be the reason behind the teen’s horrendous actions. Posted February 26, 2018. Via The Denver Post.

The FDA is recalling a diet supplement because it contains a drug that is banned. Bella All Natural has voluntarily recalled its diet supplement known as Bella because the product contains sibutramine, which is an appetite suppressant that can increase blood pressure and/or pulse rate, and sometimes causes serious health risks, including heart attack, arrhythmia and stroke. Bella All Natural has informed its distributors and has instructed customers to stop using the dietary supplement immediately. Posted February 27, 2018. Via FDA.

DOJ Going After Drug Makers in Opioid Epidemic Fight

The Department of Justice (DOJ) will form a task force to go after drug companies that have contributed to the opioid crisis by overselling the prescription painkillers. In a press conference Tuesday, Attorney General Jeff Sessions discussed how the new Prescription Interdiction & Litigation Task Force plans to combat the drug epidemic.

“This epidemic actually lowered American life expectancy in 2015 and 2016 for the first time in decades, with drug overdose now the leading cause of death for Americans under age 50,” Sessions said.

The DOJ has vowed to use all criminal and civil tools to hold distributors such as pharmacies, pain management clinics, drug testing facilities and doctors accountable for engaging in unlawful activity involving prescription opioids. The DOJ will review legislative and regulatory changes in existing laws, as well as current state and local government lawsuits against opioid manufacturers, to see whether the department can be of any help

Quick Hits: Arthritis Drugs and Dementia, Opioids and Patient Advocacy Groups & More

Rheumatoid arthritis drugs may help prevent dementia. Analysts from NIHR (National Institute for Health Research) Southampton Biomedical Research Centre identified 3,876 patients who took disease-modifying antirheumatic drugs (DMARDs), and compared them with 1,938 patients who did not. After thoroughly examining the data, researchers discovered that those who took DMARDs had around a 1.5% decreased risk (half the risk) of developing different forms of dementia, such as Alzheimer’s, compared to those who didn’t take the drugs. Posted February 12, 2018. Via Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

A report has found ties between opioid drug makers and patient advocacy groups. The report, titled, “Fueling an Epidemic: Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups,” and released by Sen. Claire McCaskill (D-Mo.), details how the pharmaceutical industry has downplayed the risks of opioid addiction in order to broaden their customer base, which in turn has resulted in “the most deadly drug epidemic in American history.” The document goes on to describe how opioid distributors and manufacturers have showered third party organizations, such as advocacy groups, with large sums of money over a lengthy period of time in order to fuel the spread of opioid prescriptions. With the financial backing, patient advocacy groups have endorsed long-term opioid use for the treatment of pain, which is not a procedure supported by medical findings. Additionally, the report notes how there is an alarming lack of transparency surrounding the advocacy organizations. Since the groups aren’t obligated to disclose their donors publicly, then the groups have the ability to conceal their financial associations with the pharmaceutical industry. Posted February 12, 2018. Via Sen. Claire McCaskill.

The makers of OxyContin (oxycodone), Purdue Pharma, will stop promoting the addictive pain medication to doctors. The company stated that they have “restructured and significantly reduced” their marketing operation. The sales team will no longer visit doctors to promote their opioid products. From now on, the company has instructed the public to direct all inquiries regarding their opioid medication healthcare professionals in their medical affairs department. Posted February 9, 2018. Via Purdue Pharma.

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.