Top Drugs in the US: #10 Norco

*Disclaimer: This is not intended to be fear mongering. However, people need to be informed of any risk associated with a medication. Sometimes, benefits outweigh the risks and therefore the medication is worth taking. Many times Pharmaceutical companies and doctors rely on the general population to just blindly take medication. FDA inserts are available to anyone, this post serves as an easy breakdown of its contents. Use this information to make an educated decision that is best for you.

Starting off strong today with the tenth most commonly prescribed drug in America: a cocktail of Hydrocodone (an opiate) and Acetaminophen (an analgesic and antipyretic). Commonly known by the brand name of “Norco“, this drug is frequently prescribed for post-operative pain management, cancer patients, and other moderate to severe trauma cases. It is classified as a Schedule II controlled substance. The majority of today’s information is directly from the FDA insert which can be found here. Other sources used for greater understanding will be linked throughout the post.

Definitions for today:

  • Opiate: a drug containing opium or its derivatives, used in medicine for inducing sleep and relieving pain, relaxes the body.
  • Analgesic: pain relievers, don’t turn off nerves, change the ability to sense your surroundings or alter consciousness. 
  • Antipyretic: reduces or prevents fever.
  • Black box warning: the highest safety-related warning that medications can have assigned by the Food and Drug Administration. These warnings bring the consumer’s attention to the major risks of the drug.
  • Schedule II Drug: drugs that have a high potential for abuse. However, there are some circumstances where they can be used by medical professionals.
  • Carcinogenesis: the initiation of cancer formation.
  • Mutagenesis: origin and development of a mutation.

Warnings and Side Effects: As described by the FDA

  • BLACK BOX Warning-Hepatotoxicity: This is common in many pain medications and usually associated with high doses for a long period of time. “Hepato” refers to the liver, so in this case, “toxicity of the liver.” This occurs because our liver acts as a filter for our blood. Once medication has been broken down/used, then it must be excreted. Depending on the medication, it can cause a lot of strain on the liver. This is especially true when used long term. According to the FDA insert, this side affect is seen when 4000mg or more are taken per day.
  • Serious skin reactions: Noted as rare.
    • Acute generalized exanthematous pustulosis (AGEP), which typically resolves after discontinuing the causative medication. AGEP is a hypersensitivity disorder.
    • Stevens-Johnson syndrome (SJS), a reaction to medication that starts with flu-like symptoms, followed by a painful rash that spreads and blisters. After, the top layer of affected skin dies, sheds and begins to heal after several days.
    • Toxic epidermal necrolysis (TEN), a life-threatening skin disorder characterized by a blistering and peeling of the skin.
  • Hypersensitivity/Anaphylaxis: Typically a reaction to the acetaminophen, and characterized by the usual anaphylactic symptoms.
  • Respiratory depression: High doses may cause this reaction. Hydrocodone can act directly upon the on the brain stem/respiratory center and cause irregular breathing.
  • Increased inter-cranial pressure: Due to the respiratory depressant tendencies and capacity to elevate inter-cranial pressure of narcotics, these effects can be elevated by the presence of a head injury. The adverse reactions of narcotics can obscure clinical presentations in head injury patients.
  • Acute abdominal conditions: Narcotic component can cause clinical diagnosis of abdominal conditions to be obscured.

Other Reactions:

  • Most common reactions: lightheadedness, dizziness, nausea, vomiting, and sedation.
  • Other Central Nervous System effects: mental clouding, lethargy, anxiety, fear, dysphoria, psychic dependence, and mood changes.
  • Other important notes:
    • No adequate studies have determined if Norco has any effect on fertility or potential for carcinogenesis and mutagenesis.
    • No adequate or well controlled studies in pregnant women.
    • It is known however, that babies born to women regularly taking opiates prior to delivery will be physically dependent.

Mechanism of Action

According to the FDA insert, the exact mechanism of action of this drug is not know. It is believed that the hydrocodone portion affects opiate receptors in the central nervous system.

The analgesic action of the acetaminophen is unknown. It is known that acetaminophen inhibits prostaglandin synthase, which is a regulator for vascular function. This likely contributes to the anti-pyretic effects.

Ingredients

Aside from the hydrocodone and acetaminophen, this medicaition contains the following “inactive ingredients”:

  • Colloidal silicon dioxide – typically used to prevent caking
  • Croscarmallose sodium – allows for disintegration of the pill
  • Crospovidone – an insoluble polymer that is used as a disintegrate in pharmaceutical tablets. It can potentially embolus to the lung when aqueous tablet suspensions are injected intravenously.
  • Microcrystalline cellulose – refined wood pulp and is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production. The most common form is used in vitamin supplements or tablets.
  • Providone – used in the pharmaceutical industry as a synthetic polymer vehicle for dispersing and suspending drugs.
  • Pregelatinized starch – used as a filler/binder
  • Stearic acid – emulsifying agent, solubilizing agent, tablet and capsule lubricant.
  • Sugar spheres composed of corn, sucrose, and FD&C yellow#6
    • Sucrose is a form of sugar
    • FD&C yellow#6 is also known as Sunset yellow FCF. It is a petroleum-derived orange azo dye.

Manufacturer/Profitability

Norco is manufactured by Mikart Inc. and distributed by Actavis Pharmaceuticals Inc.

Mikart: This company specializes in both solid and liquid oral dosage forms. They have received a few warning letters from the FDA and recently had FDA approval pulled from 25 of their medications. According to Zippia, they gross $40.8 million.

Actavis: Owned by Teva. According to their website, they are the largest generic medication producer in the world. They have been involved in multiple lawsuites, mainly in relation to their opiate drugs. This included accusation of illegal marketing which increased the number of addicts. An article with more in depth discussion of some of their lawsuits can be found here. As of November 2023, the 2023 yearly revenue for Teva Pharmaceuticals (which owns Actavis) was expected to finish around $15 billion.

Cost of Norco:

Based on prices on Drugs.com, Norco is not really a “break the bank” drug. The average cost for 30 Norco tablets is $18 if paying in cash. Insurance coverages vary and could change out of pocket cost. I have been unable to find the manufacturing cost for Norco, but will definitely update this post once I do.

Final Thoughts:

In my opinion, Norco is a drug that has a valuable time and place for use. However, I think the problem stems from the addiction it can create. Often times, the amount of pill prescribed by doctors for post-op pain are enough to create an addiction. Most people likely take the pain meds until they finish the bottle, rather than weaning off as they heal.

In regards to it being one of the top prescribed drugs, I think it makes sense. Many people undergo painful surgical procedures and cancer is on the rise. More people in pain = more pain med usage. I do think there should be better monitoring of when opiate drugs are given out. Doctors should consider providing enough for just the first couple days post-op or post-treatment, rather than enough to last the whole recovery period. Patients should be encouraged to wean themselves onto a non-narcotic medication for management.

Finally, up front, Norco does not scream “money maker” to me. It is relatively affordable out of pocket. However it could be argued that dependency on the drug creates long-term customers. This provides a guaranteed income stream for the pharmaceutical companies.

What are your thoughts on Norco? Let me know in the comments! Next week we’ll cover Drug #9: Albuterol.


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