FDA is Restricting Hydrocodone Combination Drugs to Schedule II | | RxEconsult

All Health Articles

FDA Recommends Reclassifying and Restricting Hydrocodone Combination Drugs to Schedule II Category: Pain Management by - October 26, 2013 | Views: 26552 | Likes: 1 | Comment: 4  

On January 25, 2013 an FDA advisory panel of experts voted 19 to 10 to change hydrocodone containing products from schedule III controlled drugs to the more restricted schedule II controlled substance category. Hydrocodone combination medications include:

  • Anexsia
  • Lortab
  • Norco
  • Vicodin
  • Zydone
  • Generic hydrocodone/acetaminophen

The FDA announced on October 24, 2013 that it will recommend to the US Department of Health and Human Services (HHS) that prescribing of hydrocodone combination products be restricted. The FDA has been evaluating misuse of opioids and the growing epidemic of opioid related fatalities for several years. Opioid abuse, misuse, addiction, overdose and death is a crisis. According to the Centers for Disease Control (CDC) about 3 of 4 prescription overdose deaths are caused by prescription pain killers. In 2008 14,800 deaths resulted from opioid overdose, higher than the number of deaths from cocaine and heroin abuse combined. 

Read: Impact of Switching Vicodin, Norco, Lortab to Schedule II 

The FDA expects to formally submit the recommendation to HHS in December. Once approved by HHS the Drug Enforcement Agency (DEA) will reclassify hydrocodone products. In addition to the proposed rescheduling the FDA also announced in September a new risk and evaluation mitigation strategy (REMS) that will change the indication for hydrocodone combination products. 

Read: New FDA Opioid Pain Killer Label Change

How will this channge affect how hydrocodone containing products are prescribed and the treatment of pain? 

In most states Schedule II drugs have the following restrictions:

  • Cannot be prescribed or refilled by telephone, fax, or any other electronic means unless the patient is in hospice care or during an emergency
  • Hard copy paper prescriptions are required and delivered by the patient to the pharmacy
  • More strict record and accountability 
  • May not be refilled. A new prescription is required
  • Some states may limit how many can be prescribed at a time

Should patients be concerned about the new changes?

Patients with chronic pain may be concerned that they will not be able to obtain their pain medications. The FDA is not banning prescribing of Vicodin and similar drugs. The reality is that many pain medications such as morphine, fentanyl, hydrocodone are already classified as schedule II and prescribers are comfortable with the added restrictions. This change will impact routine prescribing of opioids for short-term pain that can be treated with non-narcotic pain killers. Hopefully, it will encourage physicians to think twice before prescribing hydrocodone combination products and encourage them to educate themselves and their patients about pain management and risks of using narcotics. Patients receving chronic pain treatment with opioids should work out a plan with their prescribers so that they always have a new prescription ready when they need it. 

Are there alternatives to hydrocodone combination products? 

Alternatives to hydrocodone combination products include Tylenol with codeine (Tylenol 3) and tramadol (Ultram). There may be an increase in prescribing of tramadol or Tylenol with codeine which are also abused. Interestingly, in most states tramadol is not classified as a controlled substance even though it is addictive. 


FDA list of aproved or discontinued hydrocodone products

DEA schedules of controlled substances

FDA statement on reclassifying hydrocodone combination products

Comment on this article or post an article by joining the RxEconsult community.

Please Share on Your Social Networks


By Dr. Omudhome Ogbru

For More Healthcare Insights Join Us On Twitter
and Facebook. Join The Community To Publish Articles.

Copyright 2024 RxEconsult. All Rights Reserved | Privacy Policy | Terms of Use | Sitemap