In October of 2013, the U.S. Food and Drug Administration approved a new drug for the treatment of pain. Zohydro was developed as an abuse-deterrent form of hydrocodone, an opioid pain drug that has a high potential for addiction. This extended release form of hydrocodone offered patients a more effective method of dealing with painful conditions, but a number of questions have arisen about the manufacturer’s claims.
Controversy Erupts Over Zohydro
As soon as the drug was approved, questions regarding claims of abuse-resistance were challenged. The extended release pill contains a higher dose of hydrocodone than other medications, leading more than 40 health care, addiction treatment and consumer groups to urge revocation of the approval. Attorney general from 28 states have also voiced their concerns about the potential for abuse of the new drug, which contains 50 milligrams of hydrocodone, in a form that could easily be tampered with to produce a high. Deaths from opioid overdose have increased markedly since 2002, with opioid poisoning listed more commonly than heroin or cocaine on death certificates.
Warnings Included With Zohydro
Even while touting the abuse-resistant properties of their new form of hydrocodone, the manufacturer, Zogenix Inc., was required to provide a number of warnings in their Zohydro drug use instructions, which include such precautions as:
- Warnings about exposure to the risk of addiction
- Warnings about prolonged use of the drug during pregnancy, which can cause an opioid withdrawal syndrome in infants at birth.
- Warnings of serious, life-threatening respiratory depression with use of the drug
- Warnings about taking the drug with alcohol or other drugs.
- Warnings about interactions with CYP3A4 inhibitor medications
- Warning about accidental ingestion by children
- Warnings about a number of side effects, including constipation, nausea, vomiting, headache, fatigue, abdominal pain, dizziness, respiratory tract infection, urinary tract infection and tremor.
Questions Regarding Need for Another Opioid Drug
The Centers for Disease Control and Prevention notes that prescription opioid drug deaths have quadrupled since 1999. Whether the medical community needs a new form of hydrocodone that contains an even larger dose of the medication is questioned by many knowledgeable groups. The new drug’s potential for abuse and death from overdose is creating a climate of opposition to Zohydro that is likely to affect its marketability. Although opioid medications are recognized as valuable for cancer pain and other serious conditions, their widespread use indicates over-prescribing of these drugs for conditions that could be treated with other, less-addictive products.
Treatment for Opioid Addiction
Research shows that opioid addiction causes significant changes in the brain that must make treatment of the condition more challenging. Inpatient treatment programs must address these changes, in addition to withdrawal symptoms, management of cravings and psychological issues that may have developed either prior to, or because of, the addiction. Medication-supported treatment, cognitive behavioral therapy, family therapy and other options should all be implemented to provide the degree of treatment needed to support patients’ recovery.
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