Vicodin, Percocet face U.S. ban
The FDA is poised to ban prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic. An FDA report says the potential dangers of this combination exceed the benefit to patients.
The report found that severe liver damage, or even death, can result from taking Vicodin or Percocet. They are also highly addictive. According to the FDA, these drugs cause about 400 deaths per year, attributed to either overdoses or liver damage.
Vicodin combines hydrocodone with acetaminophen; Percocet combines oxycodone with acetaminophen. Some of the notable celebrities who have admitted addiction to one or both of these drugs include John McCain’s wife, Cindy; rapper Eminem; and comedian Artie Lange.
The recommended ban will also apply to seven other acetaminophen/narcotic combination drugs.
While alternative painkillers like Percodan, which combine opiate narcotics with aspirin (rather than liver-damaging acetaminophen), are available on the market, they had been largely replaced by Percocet and Vicodin for post-operative pain, because aspirin can interfere with platelet function and lead to excessive bleeding after surgery.
July 14th, 2009 at 11:11 pm
The FDA Meeting Issue Background Document is at:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf
Options 1(a) and 1(b) propose limitation of acetaminophen to 325mg per dose for OTC sales (and possible inclusion of all prescription formulations).
Option 5(b) proposes eliminating all prescription medications complexed with acetaminophen.
What is not (directly) stated by the FDA is the single most significant factor at play. Hydrocodone (Vicodin, Lortab) complexed with acetaminophen is a Schedule III medication. Hydrocodone (alone) is under Schedule II. And there currently is NO SUCH PRODUCT manufactured!
Thus, the FDA [if they choose to vote for Option 5(b)] will (effectively) “re-schedule” hydrocodone from Schedule III to the *much* more restrictive Schedule II (written prescriptions only, maximum 30-day supply, etc.).
Addressing the current non-existence of any hydrocodone (only) product, the FDA Background Document (lazily) states:
“For development of hydrocodone single-agent formulations, implementation would include:”
… “Submission of NDAs and ANDAs for single-ingredient hydrocodone products, which may also require clinical studies for demonstration of efficacy.”
A reported 460,000 prescriptions for hydrocodone with acetaminophen are written and filled every business day in the United States. (Despite) the fact that the public comment window has passed, all affected patients, physicians, and institutions would be wise to protest – loudly.