During a time when prescription drug abuse is completely out of control and at epidemic proportions, the FDA found its way to approve an extended-release pure hydrocodone pill, Zohydro ER. The pill is much stronger and it is pure hydrocodone.
According to an article written in the NY Daily News, the FDA said it approved the extended-release pill Zohydro ER for patients with pain that requires “daily, around-the-clock, long-term treatment” that cannot be treated with other drugs. The manufacturer of Zohydro ER is Zogenix and it is the very first of its kind in the US.
FDA Prior Votes
Last year Zohydro ER received a negative review and was not approved by an 11-2 margin. The Drug Enforcement Administration has revealed that Hydrocodone continues to be one of the most abused medications in this country. In excess of 131 million prescriptions were written in 2011. These prescriptions included morphine, oxycodone, methadone, and codeine.
Those, not in favor, are angry that the FDA didn’t at least make the manufacturer include any abuse-deterrent features. Most drug manufacturers are using temper proof containers for these types of drugs. The FDA’s approval saw bad timing and was contradictory.
Reclassifying Hydrocodone
Before Zohydro ER hydrocodone pills came along, hydrocodone was cut with either aspirin or acetaminophen so they have been easy to get ahold of. The FDA has now said they are considering changing the scheduling class for these drugs from a schedule III class to the schedule II class of medications.
Currently, pills like vicodin, oxycontin, morphine, etc. could be prescribed by nurses and other health care workers and could include refills of up to five times before needing a new prescription. Under a schedule II classification this will no longer be the case. The drugs can only be prescribed by a physician and cannot be refilled.
Stricter Laws
The newly-approved Zohydro will be regulated under the schedule II classification. The drug manufacturer will also have to investigate the drug through studies to see what the consequences of long term use will be. Common side effects currently include constipation, nausea, drowsiness, and fatigue, and dizziness, dry mouth, vomiting and itching.
