Hydrocodone: Vicodin, Hycodan, and others

While hydrocodone is a highly addictive narcotic, even when it is combined with acetaminophen (Vicodin), hydrocodone is a very poor pain reliever.  In five out of five double-blind (DB) studies, it was clearly inferior to ketorolac, or celecoxib (Celebrex) even when it had been combined with acetaminophen. One study found it was no better than acetaminophen (Tylenol).  In one study, hydrocodone with acetaminophen did no better than the non-addictive etodolac.  Compared to non-narcotics, Hydrocodone's record is no wins, 5 losses, and one tie to the weakest player in the league.  Vicodin is a loser.  

Hycodan is Endo Pharmaceuticals brand on hydrocodone.  Believe it or not, Endo also sells hydrocodone cough tablet and hydrocodone cough syrup (Hycotuss) with added guaifenesin.  That's totally insane.  Thank you, FDA.

In two studies, it added only a little bit to ibuprofen's pain relief when given as a combination pill of hydrocodone plus ibuprofen.  To the best of my knowledge, that is every study ever done comparing hydrocodone to non-addictive pain medicines.  Hydrocodone is no better than Tylenol and adds very little as an add-on pain medication.  Many other non-addictive add-on pain strategies are available. 

Clearly, hydrocodone has no place in the field of medicine in view of it highly addictive nature and very minimal benefits.  Vicodin and all forms of hydrocodone should be immediately pulled off the market.  It is virtually certain that any benefits of hydrocodone can be achieved through non-narcotic pain strategies.  Certainly, before this highly addictive narcotic should be allowed to be produced, advertised, and prescribed, it should be shown to make a clinically significant difference over available non-narcotic treatments large enough to justify the huge amount of drug abuse and addiction it is causing.  A very large number of individuals receiving Vicodin from their physicians have become addicted with many led into illegal means of obtaining their narcotics for the first time in their lives.  The much more powerful ketorolac is available with a prescription for just 65 cents a pill, roughly the same cost as generic Vicodin.  Even ibuprofen is more powerful.  Many non-narcotic pain strategies are available and much more effective.

If a doctor wants to give you hydrocodone (Vicodin and others), print out this webpage and give it to him.  If he still insists on giving you a narcotic, get another doctor.  If a doctor gave you hydrocodone and you became addicted and suffered some unfortunate consequence, the doctor and the narcotic manufacturer could be liable for malpractice.  Also, consider whether you should report the doctor to the state licensing board.  In view of the research, prescribing hydrocodone is or at least should be ruled malpractice.  

Doctors are responsible for knowing whether or not narcotics are necessary.  This research is readily available to anyone with a computer and an internet connection.  Just go to Pubmed, and enter "hydrocodone and double-blind."  

Surgery: Ketorolac Slightly Better than Hydrocodone/Acetaminophen for Arthroscopy and Laparoscopy: In an industry-financed DB PC study of 252 patients with moderate to severe post-op pain from arthroscopic or laparoscopic tubal ligation, patients received oral ketorolac 10 mg every 6 h for up to 3 days, or hydrocodone 7.5 mg plus acetaminophen 750 mg every 6 h for up to 3 days, or placebo capsules followed by ketorolac 10 mg every 6 h for up to 3 days. In the patients undergoing arthroscopic surgery, both ketorolac and hydromorphone-acetaminophen provided superior pain relief compared with the placebo. The summed pain intensity difference (SPID), visual analogue scale (VAS) SPID, and total pain relief scores were higher in the ketorolac group compared with the hydrocodone-acetaminophen group, but the differences were not statistically significant. In tubal ligation surgery, the three treatment groups displayed similar responses to the study medications. However, the ketorolac group scored higher in terms of overall tolerability than the hydrocodone-acetaminophen group. Neither oral analgesic proved to be very effective after laparoscopic tubal ligation. A comparison of oral ketorolac and hydrocodone-acetaminophen for analgesia after ambulatory surgery: arthroscopy versus laparoscopic tubal ligation. White PR, Joshi GP, Carpenter RL, Fragen RJ. University of Texas Southwestern Medical Center at Dallas. Anesth Analg. 1997 Jul;85(1):37-43.

Dental Surgery: Hydrocodone (Vicodin) Adds Only Slight Extra Pain Relief to Ibuprofen in Dental Surgery: In a DB crossover study with the patients acting as their own controls, 12 patients underwent two periodontal surgeries in different quadrants of the same dental arch at least 2 weeks apart. Patients received four doses of medication at predetermined intervals and filled out a visual analog pain scale every 2 hours for the first 12 hours after surgery. More pain was reported with ibuprofen alone, 1.81 out of a possible 10, compared to the ibuprofen with hydrocodone combination, 1.30. The difference was statistically significant (P<0.05). Efficacy of ibuprofen-hydrocodone for the treatment of postoperative pain after periodontal surgery. Betancourt JW, Kupp LI, Jasper SJ, Farooqi OA. Mayo Clinic. J Periodontol. 2004 Jun;75(6):872-6. 

Dental Surgery: Hydrocodone Inferior to Ketorolac Yet Causes More Side-Effects: In a DB PC study of 207 patients having removal of impacted third molars, a single oral dose of 10 mg of ketorolac  resulted in less pain at 3 and 6 hours that 10 mg of hydrocodone plus 1000 mg of acetaminophen, or placebo (P < or = 0.01). Patients taking hydrocodone/acetaminophen remedicated significantly (P = 0.027) sooner and had more side-effects. Pain relief after dental impaction surgery using ketorolac, hydrocodone plus acetaminophen, or placebo. Fricke, et al. Pharmaco-LSR, Austin, Texas. Clin Ther. 1993 May-Jun;15(3):500-9.

Dental Surgery: Periodontal Osseous Surgery: Etodolac (Lodine) as Good as Hydrocodone/Acetominophen: In an 8-hour single blind study of 24 patients, patients in the etodolac group received two 300 mg capsules 30 minutes prior to surgery and then redosed themselves prn. Patients who received the combination drug were not premedicated and followed a prn regimen. The subjects used a verbal analogue scale to report levels of pain hourly for the first 8 hours (starting 30 minutes prior to surgery). The time span from 30 minutes prior to the beginning of surgery to the first postsurgical dose was greater for etodolac than for the combination drug. However, the total number of medications taken under both regimens was similar. The side effects were minimal for both. Both provided comparable pain relief. A comparison of 2 analgesic regimens for the control of postoperative periodontal discomfort. Tucker PW, Smith JR, Adams DF. Oregon Health Sciences University, Portland, USA. J Periodontol. 1996 Feb;67(2):125-9. Ed: Etodolac generic costs $1.15 per 500 mg tablet. 

Rofecoxib versus hydrocodone/acetaminophen for postoperative analgesia in functional endoscopic sinus surgery.

Church CA, Stewart C 4th, O-Lee TJ, Wallace D.

Division of Otolaryngology-Head and Neck Surgery, Loma Linda University School of Medicine, Loma Linda, California 92354, USA. [email protected]

OBJECTIVES/HYPOTHESIS: Functional endoscopic sinus surgery (FESS) is less invasive and more tissue sparing than extirpative techniques, with an assumed benefit of diminished postoperative pain. Oral opioids are commonly prescribed after sinus surgery but are associated with adverse effects, including gastrointestinal and neurologic symptoms. Nonopioid analgesics have been suggested to offer similar pain control efficacy with fewer adverse effects. STUDY DESIGN: To investigate postoperative analgesia in FESS, a prospective randomized, double-blinded comparison of hydrocodone/acetaminophen 7.5/750 mg (an opioidderivative) with rofecoxib 50 mg (a cyclooxygenase-2 inhibitor) was performed. METHODS: Forty subjects were enrolled, of which 28 successfully completed the study. Subjects recorded peak pain levels and requirement for rescue analgesia on the day of surgery and for 4 days thereafter. On postoperative day 5, subjects completed an exit survey in which adverse effects and overall satisfaction with pain control were recorded. RESULTS: In this study, there were no statistical differences in peak pain levels between the groups at any point in the postoperative period, regardless of extent of surgery. Adverse effect profiles were also similar for the two groups. CONCLUSIONS: The use of nonopioid analgesics after FESS may provide similar pain control to oral opioids. Laryngoscope 2006 Apr;116(4):602-6.

Postpartum Pain: Hydrocodone No Better than Acetaminophen: In a double-blind study, 108 postpartum patients received single oral doses of either placebo, acetaminophen (paracetamol) 1000 mg, hydrocodone 10 mg, the combination of acetaminophen plus hydrocodone, or codeine 60 mg. Both the acetaminophen and hydrocodone effects were statistically significant, whereas the interaction contrast was not. Although significantly superior to placebo, codeine seemed to be inferior to the other treatments. Methodological considerations in the evaluation of analgesic combinations: acetaminophen (paracetamol) and hydrocodone in postpartum pain. Beaver WT, McMillan D. Br J Clin Pharmacol. 1980 Oct;10 Suppl 2:215S-223S.

Arthroscopic Knee Surgery: Ketorolac Superior to Hydrocodone/Acetaminophen: In a DB study of 125 out-patients with an arthroscopically assisted patellar-tendon autograft anterior cruciate ligament reconstruction, a loading dose of parental ketorolac tromethamine was administered and subjects were later given two staged doses of the same "unknown" drug with pain evaluations conducted after each dose. For group 1, dose 1 consisted of ketorolac tromethamine 20 mg orally and dose 2 was ketorolac tromethamine 10 mg. For group 2, both dose 1 and dose 2 consisted of hydrocodone 10 mg plus acetaminophen 1,000 mg orally. Efficacy was evaluated by standard analgesic measures. Outpatients showed lower categorical pain intensity for ketorolac than hydrocodone/acetaminophen at 1 hour (P=.03), 2 hours (P=.006), and 3 hours (P=.02); and lower summed intensity differences for ketorolac at 3 hours (P=.014) and 4 hours (P=.019); and better total pain relief for ketorolac at 3 hours (P=.014) and 4 hours (P=.013). Moreover, ketorolac tromethamine was no more likely to cause digestive complaints than hydrocodone and acetaminophen. No bleeding problems were observed in either group. Comparison of oral ketorolac and hydrocodone for pain relief after anterior cruciate ligament reconstruction. Barber FA, Gladu DE. Plano Orthopedic and Sports Medicine Center, Texas. Arthroscopy. 1998 Sep;14(6):605-12.

Orthopedic Surgery: Celecoxib (Celebrex) Clearly Better than Hydrocodone/Acetaminophen: In 5-day DB PC studies of 418 patients with acute pain after orthopedic surgery, celecoxib 200 mg, was compared to hydrocodone 10 mg/acetaminophen 1000 mg, or placebo. Mean pain intensity difference (PID) favored the active treatments over placebo from 1 to 6 hours (P < or = 0.016) and favored celecoxib over the other treatments at 7 and 8 hours after dosing (P < 0.001). Over the full 5 days with each medicine given up to 3 times a day, more hydrocodone/acetaminophen patients (20%) than celecoxib patients (12%) required rescue medication (P < 0.05), and the celecoxib group had significantly lower maximum pain intensity scores (P < 0.001, days 2-5), required fewer doses of study medication (P < or = 0.01, days 3-5), and had superior scores on a modified American Pain Society Patient Outcome Questionnaire (P < or = 0.013). Celecoxib patients had many fewer adverse events (43%) compared with hydrocodone/acetaminophen (89%; P < 0.001). Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. Gimbel JS, Brugger A, Zhao W, Verberg KM, Geis GS. Arizona Research Center LLC, Phoenix. . Clin Ther. 2001 Feb;23(2):228-41.

Abdominal Surgery: Hydrocodone/Ibuprofen Helped 25% More Patients than Ibuprofen Alone: In a 6-hour DB PC study of 120 patients after abdominal surgery with moderate to severe postop pain, the combination of 15 mg hydrocodone bitartrate with 400 mg ibuprofen was significantly superior to ibuprofen alone for all hourly analgesic evaluations, weighted sum of pain intensity differences (SPID), total pain relief (TOTPAR), and global rating of study medication. No patients in the hydrocodone with ibuprofen group required analgesic remedication during the 6-hour study period, compared with 25% with ibuprofen and 82% with placebo. Analgesic efficacy of a hydrocodone with ibuprofen combination compared with ibuprofen alone for the treatment of acute postoperative pain. Sunshine A, et al. NYU Medical Center. J Clin Pharmacol. 1997 Oct;37(10):908-15. Ed: Three quarters of ibuprofen patients appear to have been needlessly given a powerfully addictive narcotic.  Ibuprofen 400 mg by itself appears to work well for 75% of all patients. 

Vicodin-induced fulminant hepatic failure. Anesthesiology. 1993 Oct;79(4):857-60.

Profound hearing loss associated with hydrocodone/acetaminophen overuse: 12 cases. Am J Otol. 2000 Mar;21(2):188-91.

Psychosis after ultrarapid opiate detoxification. Am J Psychiatry. 2001 Jun;158(6):970.

Palladone Pulled From Market by FDA: After acquiring new information that serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol, the U.S. Food and Drug Administration asked Purdue Pharma L.P. to withdraw it from the market.  Palladone is a once-a-day pain drug. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping. Dose-dumping is a term that describes the rapid release of the active ingredient from an extended release product into the blood stream. The consequences of dose dumping at the lowest marketed dose (12 mg.) of Palladone could lead to serious, or even fatal, adverse events in some patients and the risk is even greater for the higher strengths of the product. As a result of this potential serious safety risk, the FDA has asked Purdue Pharma, and they have agreed, to suspend all sales and marketing of Palladone in the U.S. pending further discussions with the agency.  Dr. Steven Galson, FDA Acting Director of the Center for Drug Evaluation and Research. 7/13/05