What Is Zohydro Addiction?

Introduction

Zohydro ER, an extended-release form of hydrocodone bitartrate, has been both a pivotal option in pain management and a point of contention since its approval in 2013. As an opioid with a significant potential for addiction, its use and misuse are deeply intertwined with the opioid crisis faced globally. This article delves into what Zohydro addiction entails, exploring its implications, risks, and the balanced complexities of pain management.

The Role and Risks of Zohydro in Pain Management

What is Zohydro used for?

Zohydro ER (hydrocodone extended-release) is primarily used to treat severe pain that requires round-the-clock, long-term opioid administration when other treatments are insufficient. It is formulated as extended-release capsules and is typically taken twice daily, with an initial recommended dose of 10 mg every 12 hours for patients who are not already on opioids.

Originally approved by the FDA in 2013, Zohydro was reformulated in 2015 to incorporate BeadTek™ technology, which helps deter abuse by making the capsules difficult to crush. Clinical trials demonstrated significant pain relief compared to placebo, although the medication does carry risks such as constipation, nausea, and respiratory depression.

Due to its potential for abuse, there are regulatory requirements for pharmacists to provide warnings when dispensing Zohydro ER. The FDA has classified Zohydro ER as a Schedule II controlled substance, indicating a high potential for abuse and addiction, particularly for individuals with a history of substance use disorders.

Monitoring is essential as patients on Zohydro must be regularly assessed for signs of misuse and addiction. This vigilant approach is crucial in balancing effective pain management with the risks presented by potent opioids like Zohydro.

The Controversial Approval and Availability of Zohydro

FDA Approval Process and Controversies

Zohydro ER, a formulation of hydrocodone bitartrate, gained FDA approval on October 25, 2013. Despite significant opposition, the FDA made this decision despite a negative vote (11 to 2) from its advisory panel, which expressed serious concerns regarding the drug's high potential for addiction and misuse. This controversial approval was largely based on the increasing demand for pain management options; however, it stood on shaky ground due to overstated prevalence figures of severe pain sufferers. Health organizations and experts raised alarms about Zohydro's addictive nature shortly after its approval, linking it to a dramatic rise in opioid prescriptions and overdose deaths.

Current Availability Status

As of recent updates, Zohydro ER has been discontinued in the U.S. market. While the brand itself is no longer prescribed, generic versions of hydrocodone may still be available. This medication is strictly indicated for chronic pain management when other options are inadequate and carries a high risk of abuse and serious side effects. Given these risks, patients need careful monitoring, and responsible usage is a must to prevent misuse. Always consult a healthcare provider for alternatives and ensure any opioid treatment adheres to safety guidelines.

Understanding the Potency and Comparisons of Zohydro

Is Zohydro stronger than other forms of hydrocodone?

Zohydro ER (hydrocodone bitartrate) is an extended-release formulation specifically designed for managing severe pain that necessitates long-term opioid treatment. Despite its status as a single-entity hydrocodone product, it is not necessarily stronger in terms of effectiveness when compared to combination products like Vicodin, which contains hydrocodone and acetaminophen.

In fact, a 10 mg dose of Zohydro ER correlates in potency to a 10 mg dose of Vicodin. One of the significant distinctions of Zohydro ER is the absence of acetaminophen, minimizing the risk of liver damage—a common concern with other hydrocodone medications.

However, it's crucial to note that while Zohydro ER provides long-acting pain management—designed for effects lasting up to 12 hours—the maximum dosage of Zohydro ER (up to 50 mg) is lower than that of some extended-release opioids, such as oxycodone and morphine. This comparative advantage must be balanced against the associated risk factors.

To tackle potential misuse and added risks due to its potency, Zogenix has initiated various safety measures, including educational programs to inform healthcare providers about responsible prescribing practices and recommended secure storage solutions for patients. These initiatives aim to mitigate misuse while ensuring effective pain relief for those in need.

How Zohydro is Administered Safely

How is Zohydro administered?

Zohydro ER is administered orally. For individuals who are opioid-naïve, the recommended starting dose is one 10 mg capsule taken every 12 hours. This dosing schedule is specifically designed for managing severe pain that requires consistent, long-term opioid treatment when other alternatives have proven inadequate.

It's crucial for patients to be cautious of associated risks, especially during the initiation of treatment or when dosages are adjusted. These risks include addiction, respiratory depression, and the potential for overdose.

Dosage advisory and risks

Patients must strictly adhere to prescribed dosages to mitigate risk. The FDA advises against mixing Zohydro ER with alcohol due to the increased chances of a fatal overdose. Sharing the medication is also dangerous, particularly as it can lead to accidental ingestion by others, including young children, which can be life-threatening.

Avoiding misuse

To ensure safe usage, patients should constantly monitor their own experience with the medication and reach out to healthcare providers if they have concerns about misuse or addiction. Additionally, it's advisable to regularly consult the FDA Online Label Repository to obtain the latest information regarding the safe and effective use of Zohydro ER. By following thorough management guidelines, patients can better navigate the risks associated with this potent medication.

Signs and Symptoms of Zohydro Addiction

Behavioral Indicators

Recognizing addiction to Zohydro ER (hydrocodone bitartrate) begins with observing behavioral changes. Common signs include:

• Obsessive Focus: Individuals may become fixated on obtaining and using Zohydro, often prioritizing it over responsibilities and relationships.
• Neglect of Activities: A noticeable decline in interest in previously enjoyed activities can occur as Zohydro becomes the primary focus.
• Deceitful Behaviors: Patients may lie about their usage, misrepresent prescriptions, or resort to stealing to obtain more of the drug.

Physiological Signs

Physical symptoms of Zohydro addiction can also be evident:

• Tolerance Development: Users may require higher doses to achieve the same pain-relieving effects, indicating the body’s adaptation.
• Withdrawal Symptoms: Abruptly stopping can lead to symptoms such as nausea, restlessness, muscle aches, and anxiety.
• Central Nervous System Depression: Signs such as slow breathing, confusion, or unresponsiveness can indicate severe misuse.

Risk Factors

Several factors can heighten the risk of developing an addiction to Zohydro:

• History of Substance Abuse: Individuals with previous drug or alcohol use disorders are at a higher risk of developing addiction.
• Chronic Pain Patients: Those using Zohydro for long-term pain management may also unknowingly increase their risk of dependence.
• Multi-Prescriptions: Older adults or those taking multiple medications concurrently face increased dangers related to misuse and addiction.

Treatment Options for Zohydro Addiction

Medical Detox

For individuals struggling with Zohydro addiction, medical detox is often the first step. Detox helps manage withdrawal symptoms that can arise from suddenly stopping the medication. Under professional supervision, the tapering of the dosage can minimize discomfort and reduce the risk of severe withdrawal symptoms such as nausea, anxiety, and physical pain.

Therapy and Rehabilitation

Once detox is complete, various therapeutic options can support recovery. Patients may benefit from both inpatient and outpatient rehabilitation programs that focus on behavioral therapies. These therapeutic approaches address the underlying causes of addiction and help develop coping strategies to manage pain without relying on opioids. Counseling sessions may include cognitive behavioral therapy (CBT) and support groups like Narcotics Anonymous, which are vital to maintaining long-term recovery.

Preventative Measures

Preventative measures are essential for reducing recurrence. Continuous education on the risks associated with opioid use and fostering open communication with healthcare providers can help patients recognize addictive behaviors early. Patients should also have regular assessments for pain management alternatives and support for mental health issues. By adopting a comprehensive approach that encompasses detox, therapy, and prevention, individuals can better navigate their recovery journey and decrease the likelihood of relapse.

Addressing the Opioid Crisis Through Education and Policy

Educational Initiatives

To combat the rise in opioid addiction linked to medications like Zohydro ER, medical professionals are emphasizing the need for enhanced educational practices. Training programs aimed at healthcare providers can ensure they understand the risks associated with prescribing opioids, particularly those without abuse deterrent features like Zohydro. This education can include ways to identify patients at higher risk for addiction, such as individuals with a personal or family history of substance abuse.

Policy Changes

Policy reforms are also crucial in managing the opioid crisis. Legislation aimed at regulating opioid prescriptions can help curb unnecessary use and prevent overprescribing. Establishing guidelines for prescribing Zohydro specifically, alongside an emphasis on alternative pain management strategies, can reduce reliance on potent opioids.

Healthcare Provider Assessments

Regular assessments of patients' risk of addiction are vital during opioid therapy. Providers should monitor usage patterns and potential signs of misuse to ensure that patients remain within safe boundaries while managing chronic pain. This proactive approach, coupled with community education on the dangers of opioids, can help mitigate the impact of medications like Zohydro on public health.

Conclusion

The journey of Zohydro, from its FDA approval amidst controversy to its impact on pain management and addiction, underscores the complexity of balancing effective pain relief with the risks of addiction. While its role in pain management for certain patients is undeniable, the broader narrative is a cautionary tale about opioid prescriptions. Continuing education, policy improvements, and vigilant monitoring can help mitigate the risks associated with Zohydro and similar opioids, fostering a safer environment for both patients and healthcare providers.

References

• Chronic Pain, Addiction, and Zohydro
• Zohydro ER Oral: Uses, Side Effects, Interactions, Pictures ... - WebMD
• [PDF] ZOHYDRO ER (HYDROCODONE BITARTRATE) Label
• Zohydro approval by food and drug administration - PubMed
• FDA Provides Facts About Zohydro
• Zohydro ER 2014 | College of Pharmacy
• Zohydro: The Risks of Extended-Release Painkiller Abuse
• Zohydro ER Abuse and Addiction - Recovery in Tune
• Hydrocodone Addiction And Abuse