January 9, 2020

Three Drug Approvals and a Safety Warning

FDA Approves Avsola – Biosimilar for Remicade

The FDA approved Avsola (infliximab-axxq) injections, a biosimilar to Remicade (infliximab). This drug is indicated for the treatment of:

  • Crohn’s Disease
  • Ulcerative colitis
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Plaque psoriasis

Dosing guidelines vary significantly per indication. Adverse reactions include infections, infusion-related reactions, headache, and abdominal pain.

In various industries, workers may develop various forms of arthritis due to cumulative or acute trauma, resulting in the prescription of osteoarthritis drugs. This has led to certain specialty medications for inflammatory conditions appearing in workers' comp claims, with drugs for other arthritis conditions being prescribed off-label. Furthermore, it is possible for occupational injury to aggravate pre-existing inflammatory joint disease that may have been previously mild.

FDA Approves Dayvigo for Insomnia

The FDA has approved Dayvigo (lemborexant) tablets for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

In workers’ comp populations, insomnia is a common side effect from opioid therapy. In the event patients are prescribed medication to treat insomnia, Dayvigo could make its way into workers’ comp claims.

Please work with your pharmacy team to ensure appropriate insomnia treatment options are selected.

Dayvigo should not be used by patients with narcolepsy. Adverse reactions include drowsiness. For further information, read the FDA-approved drug label.

FDA Approves Ubrelvy for Migraine

The FDA approved Ubrelvy (ubrogepant) tablets for the treatment of migraine with or without aura. Ubrelvy is not indicated for the preventive treatment of migraine, and will be available in 50 mg or 100 mg doses.

In workers’ comp, migraines can arise as a result of traumatic head injury, or certain injuries can exacerbate preexisting migraine disorders.

Adverse reactions of Ubrelvy include nausea and somnolence.

FDA Warns About Breathing Problems for Pregabalin and Gabapentin

The FDA issued a warning that serious breathing difficulties may occur for individuals taking gabapentin or pregabalin who have respiratory risk factors. These risk factors can include the use of opioid pain medications and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function.

Gabapentin (Neurontin®, Gralise®, and Horizant®) and pregabalin (Lyrica®, and Lyrica® CR) are used for a variety of conditions, including seizures and nerve pain, conditions which are common in workers’ compensation. It is therefore possible that injured workers could be taking gabapentinoids along with opioids, leading to potential breathing difficulties.

Furthermore, as prescribers shift away from opioid pain medications, the prescribing of gabapentin and pregabalin has increased, meaning that a larger pool of patients and injured workers could be at risk of these breathing difficulties if they are predisposed to respiratory risk.

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