Drugs

FDA Wants Opana ER Pulled from Market

FDA is asking Endo Pharmaceuticals to remove its Opana ER (oxymorphone hydrochloride) opioid pain medication from the market based on a concern that the drug’s benefits may no longer outweigh its risks. An agency news release says it is the first time FDA has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

The agency says its decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. It says that injection abuse of Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy.

At a 3/2017 FDA advisory committee meeting, members voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.

The drug was approved in 2006 to manage moderate-to-severe pain when a continuous, 24-hour opioid analgesic is needed for an extended period of time. Endo reformulated it in 2012 to make it resistant to physical and chemical manipulation for abuse by snorting or injecting. The release says that while the product met the regulatory standards for approval, FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse, and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER.

If Endo chooses not to withdraw the product, FDA says it will take steps to formally require its removal by withdrawing approval. In the interim, it says it is making healthcare professionals and others aware of the particularly serious risks associated with abusing this drug.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome