FDA pressures Endo to take opioid off market amid public health crisis: 6 things to know

The Food and Drug Administration on Thursday requested drugmaker Endo International to remove its opioid painkiller Opana ER from the market due to public health concerns regarding the nationwide rise in opioid epidemic, reports The New York Times.

Here are five things to know.

  1. Opana ER — first approved in 2006 — is heavily misused by individuals who crush the pills into powder and then snort or inject it. The drug is also linked to outbreaks of HIV, hepatitis C and a serious blood disorder, according to the report.

  1. In 2012, Endo released an FDA-approved reformulation of the drug designed to be harder to crush to deter illicit use. However, individuals developed workarounds to get the drug into an injectable form.

  1. An FDA advisory panel in March agreed the benefits of the long-lasting opioid no longer outweighed the health risks attributable to its misuse, according to the report.

  1. The FDA's request marks the first time the agency called on a drugmaker to withdraw an opioid painkiller for public health reasons.

  1. Endo's intent to comply with the agency's request is unclear. The drugmaker said it is "evaluating the full range of potential options as we determine the appropriate path forward," according to a prepared statement.

  1. If Endo refuses to remove Opana ER from the market, the FDA could hold a hearing where the drugmaker may argue why the drug should be kept on the market, reports Reuters. Following the hearing, the FDA could withdraw approval of Opana ER, according to the report.

More articles on opioids:

Fentanyl linked to majority of drug overdoses in Rhode Island
New bill seeks harsher penalties for synthetic opioids
Dayton mayor files suit against physicians, drugmakers and drug distributers for role in Ohio opioid crisis

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