PHARMACY

FDA warns against combined use of opioids and benzodiazepines

BY Michael Johnsen

SILVER SPRING, Md. – The U.S. Food and Drug Administration announced Wednesday that it is requiring class-wide changes to drug labeling, including patient information, for almost 400 products to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system depressant drugs called benzodiazepines.

“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” stated FDA Commissioner Robert Califf. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks.”

Among the changes, the FDA is requiring boxed warnings – the FDA’s strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products and benzodiazepines with information about the serious risks associated with using these medications at the same time.

Risks include extreme sleepiness, respiratory depression, coma and death. Today’s actions are one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.

Given the importance of reaching health care professionals and the public with information about the risks of using these products together, today the FDA also issued a Drug Safety Communication. Through the Drug Safety Communication and by requiring patient Medication Guides, the agency also provides information for anyone who is taking, or who knows someone taking, either of these types of medications and encourages them to better understand the risks of taking them together; and, when it is medically necessary, for health care providers to be careful to prescribe them as directed, without increasing the dose or dosing frequency for either drug.

Opioid analgesics are pain-reducing medications that include prescription oxycodone, hydrocodone, and morphine, among other drugs, under both brand and generic names. Certain other opioid medications are also approved to treat cough.

Benzodiazepines are drugs typically prescribed for the treatment of neurological and/or psychological conditions, including anxiety, insomnia and seizure disorders. Both classes of drugs depress the central nervous system (“CNS depressants”); however, each has unique pharmacology, safety risks, and labeling information related to its use.

Therefore, the FDA is requiring opioid analgesics, prescription opioid cough products and benzodiazepines to have slightly different labeling. Additionally, due to the unique medical needs and benefit/risk considerations for patients undergoing medication-assisted therapy treatment to treat opioid addiction and dependence, the FDA is continuing to examine available evidence regarding the use of benzodiazepines and opioids used as part of MAT.

The FDA’s data review showed that physicians have been increasingly prescribing them together, and this has been associated with adverse outcomes. The number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41% between 2002 and 2014, which translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.
 

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WSJ: FDA inspection scuttles Theranos’ Zika-virus emergency clearance request

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FDA approves Erelzi, a biosimilar to Enbrel

BY Gina Acosta

WASHINGTON — The U.S. Food and Drug Administration has approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases.

Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
Erelzi is administered by injection for the treatment of:

  • moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
  • moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older
  • active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone
  • active ankylosing spondylitis (an arthritis that affects the spine)
  • chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

The FDA says its approval of Erelzi is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel. Erelzi has been approved as a biosimilar, not as an interchangeable product. Erelzi should not be administered to patients with sepsis.

The most serious known side effects with Erelzi are infections, neurologic events, congestive heart failure and hematologic events. The most common expected adverse reactions with Erelzi are infections and injection site reactions.
 

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