Calling themselves a “niche” pharmaceutical company, Akorn Pharmaceuticals develops, markets, and manufactures both branded and generic prescription pharmaceuticals, over-the-counter (OTC), consumer health, and animal healthcare products. Akorn’s specialty is in sterile, nonsterile, and difficult-to-manufacture dosage forms, such as injectables.
The pharmaceutical company Akorn markets and manufactures several branded prescription ophthalmic solutions and gels, including Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution), Akten (lidocaine HCL ophthalmic gel), AzaSite (azithromycin ophthalmic solution), Betimol (timolol ophthalmic solution), Paremyd (hydroxyamphetamine hydrobromide tropicamide ophthalmic solution), phenylephrine hydrochloride ophthalmic solution, USP, and Zioptan (tafluprost ophthalmic solution) as well as Ak-Fluor (fluorescein injection) and IC Green (indocyanine green for injection), which are used as intravenous diagnostic aids. Akorn also markets Xopenex (levalbuterol HCL) in an inhalation solution for the treatment of bronchial spasms and Amicar as the only aminocaproic acid (for the treatment of fibrinolytic bleeding) available in oral form on the market today.
Since the foundation of Taylor Pharmaceuticals in 1948, then Akorn Ophthalmics in 1971, and the merger of the two in 1992, Akorn Pharmaceuticals has made large strides in the healthcare industry in eye care and beyond. Akorn has developed new and innovative pharmaceutical solutions as well as acquired the rights to manufacture and market several more throughout the years.
They have also had their share of legal issues. In 2014, Akorn was hit with several lawsuits from shareholders after misrepresenting earnings following a merger, and FiercePharma reports that stock prices crashed as a result of the associated class-action lawsuits. In late 2016, the U.S. Food and Drug Administration (FDA) sent a precursor to a warning letter to Akorn after several quality control issues at the Illinois sterile drug-making facilities were noticed during an inspection, the Regulatory Affairs Professionals Society (RAPS) publishes. This came after a warning letter from the FDA in 2007 for a failure to adhere to procedures that ensure sterility.
Overall, Akorn remains a top pharmaceutical company marketing several prescription and brand-name medications.
In addition to its veterinary, eye care, and OTC pharmaceutical products, Akorn also manufactures and markets several controlled substances. Drugs that are classified as controlled substances by the Drug Enforcement Administration (DEA) are considered to have at least some risk for diversion, abuse, and potentially addiction. Schedule I drugs are the highest classification, and these substances have no accepted medical uses in the United States; they are therefore considered illegal and include drugs like heroin, LSD, ecstasy, PCP, etc. Schedule II controlled substances have the tightest regulation for drugs that do have accepted medical uses, and these substances are considered to have a high potential for diversion, abuse, and addiction. Akorn manufactures several Schedule II controlled substances, including Nembutal Sodium Solution (pentobarbital sodium injection, USP), Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution), and Sublimaze (fentanyl citrate injection, USP).
NembutalNembutal is a barbiturate drug that has both sedative and anticonvulsant properties. It may be abused, as it can have intoxicating effects similar to those associated with alcohol. It is extremely dangerous when used for nonmedical purposes and without the supervision of a medical professional for medical reasons.
As a central nervous system (CNS) depressant, Nembutal can slow down some autonomic and life-sustaining functions like heart rate, body temperature, respiration, and blood pressure. An overdose can be life-threatening, especially when Nembutal is mixed with other CNS depressant drugs like opioids, benzodiazepines, or alcohol. Nembutal is extremely habit-forming and can lead to drug dependence, difficult withdrawal symptoms, and addiction with regular abuse.
Lortab and SublimazeBoth Lortab and Sublimaze contain opioid drugs (hydrocodone and fentanyl respectively), which are also widely abused and highly addictive. Lortab also contains the OTC analgesic acetaminophen. The National Institute on Drug Abuse (NIDA) reports that between 26.4 million and 36 million people around the world abuse opioid drugs, including both the illegal drug heroin and prescription opioids.
Prescription opioids are pain medications designed to treat moderate to acute pain. They bind to opioid receptors in the brain, which blocks pain sensations. They are also CNS depressants and slow respiration, blood pressure, and heart rate while reducing anxiety and promoting relaxation and sedation. They can be habit-forming, and drug dependence can form quickly even when the drugs are used as directed with a legitimate and necessary prescription. Individuals can build up a tolerance to opioid drugs that will require them to increase their dosage to keep feeling the effects. Drug dependence forms as brain chemistry is altered and adjusts to the interaction of the opioid with neurotransmitters like dopamine. Dopamine is one of the brain’s chemical messengers that signals pleasure and helps to regulate moods.
Drugs like Lortab and Sublimaze may be commonly diverted from licit channels. The DEA reports that fentanyl (the active ingredient in Sublimaze) is often stolen or diverted through illegal distribution or fraudulent prescriptions. When opioids are used for nonmedical purposes or recreationally, dopamine levels spike in the brain, causing a burst of euphoria, or a “high.” This high can be very desirable, leading individuals to keep abusing the drugs to repeat the good feelings.
When opioid drugs wear off, it can leave individuals feeling depressed, restless, irritable, and anxious. After dependence forms, withdrawal effects include flu-like symptoms and intense drug cravings as well. The American Society of Addiction Medicine (ASAM) publishes that around 2 million people struggled with addiction involving a prescription opioid drug in 2014 within the United States. Both Lortab and Sublimaze have a high risk for abuse and subsequent addiction.
Dangers of Sublimaze
Sublimaze is generally only used in a hospital setting for the short-term relief of pain, often the kind associated with surgeries or medical procedures. Its active chemical, fentanyl, is extremely potent; it is between 50 and 100 times more potent than morphine, for example, NIDA warns. This high level of potency makes it a very dangerous drug to abuse.
The risk for fentanyl overdose is very high. Fentanyl can be lethal in as small as a 2 milligram dose, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) warns. Since Sublimaze is injected, the drug rapidly enters the bloodstream and begins working almost immediately. The following are potential signs of a fentanyl overdose:
- Bluish color to the skin, nails, and lips
- Cold and clammy skin
- Mental disorientation and confusion
- Dilated pupils
- Trouble breathing or shallow breaths
- Weak pulse and slow heart rate
- Extreme drowsiness and trouble staying awake
- Uncoordinated movements
- Loss of consciousness
Sublimaze is even more dangerous if it is taken with other drugs or alcohol, which increases the odds for a potentially life-threatening overdose. The Centers for Disease Control and Prevention (CDC) reports that the United States is in the throes of an opioid overdose epidemic, and overdoses related to synthetic opioids such as fentanyl close to doubled between 2013 and 2014. The CDC further publishes that 91 people die from an opioid overdose in the United States every day, including deaths from both prescription opioids and the illegal drug heroin. In addition to overdose, Sublimaze has a high risk for the formation of drug dependence, difficult emotional and physical withdrawal symptoms, and addiction. Sublimaze dependence and addiction require specialized treatment which generally begins with a medical detox program in order to safely process the drug out of the body while managing possible withdrawal symptoms and helping to minimize relapse. Medications, therapeutic measures, and supportive care are all beneficial in the treatment of opioid addiction.
Since Akorn produces these drugs that have a high potential for abuse and dependency, they include disclaimers regarding this potential in each drug’s packaging information.