Drugs

NY Reaches Agreement with Endo over Opana ER Marketing

New York has reached an agreement with Endo Pharmaceuticals over its marketing of long-acting opioid, Opana ER. The agreement requires Endo to “cease all misrepresentations regarding the properties of Opana ER, to describe accurately the risk of addiction to Opana ER, and to summarize studies regarding Opana ER on its Web site,” according to a release from NY Attorney General Eric T. Schneiderman. “Endo must also create a program that will prevent its sales staff from promoting this powerful narcotic painkiller to health care providers who may be involved in the abuse and illegal diversion of opioids. My office is committed to ensuring that prescription drugs are marketed and prescribed responsibly – and that consumers get the information they need about the serious risks associated with painkillers, such as addiction.”

Schneiderman says that between 2008 and 2011, the annual number of opioid painkiller prescriptions filled by New York City residents increased by 31%, from 1.6 million to 2.2 million. The resulting increase in the prescribing of opioids is associated with a sharp increase in opioid addiction, which in turn has been associated with a rise in overdose deaths and heroin use, he says.

Based on concerns about the role Opana ER has played in the larger opioid abuse epidemic and Endo’s marketing practices, Schneiderman launched an investigation. It found that Endo improperly marketed the drug as designed to be crush resistant, when apparently the company’s own studies showed that the pill could be crushed and ground. “This may have bolstered Opana ER sales, but provided a false sense of security to health care providers and their patients,” he says. His investigation also found that Endo improperly instructed its sales representatives to distort risks associated with Opana ER, including serious dangers involving addiction.

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