Posts Tagged 'FDA'

In Wake of Crisis, FDA Targets Single Opioid for Removal

fda targets one of many opioids for removal due to abuseThe FDA has begun the process of removing a powerful opioid from the market over concerns of the potential for abuse. Endo Pharmaceuticals was recently informed by the agency that it would like to see Opana ER pulled from the nation’s shelves.

Citing concerns over the “public health consequences of abuse,” the agency is giving Endo Pharmaceuticals the opportunity to voluntarily remove Opana ER on its own. ...

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Study Discovers Safety Risk in One-third of FDA-approved Drugs

one-third of FDA approved drugs not safeA recent study published in the Journal of the American Medical Association has identified that one-third of FDA-approved drugs carry a safety risk that is found after the medications have already gone to market. It’s a rate that’s both alarming and unexpected from an agency that is supposedly charged with protecting the public’s health.

Joseph Ross, an associate professor of medicine and public health at Yale University and ...

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FDA Issues New Warning for Opioid Painkillers for Children

FDA strengthens warnings on opioids for childrenThe New York Times reports that the FDA has strengthened its warnings for opioid medications for children. Specifically, they advise that those 12 and younger are not to take codeine, while those 18 and younger should not take tramadol after certain types of surgery. In addition, nursing mothers are advised to avoid both drugs because they could impact breastfeeding.

As the strongest type of warning levied by ...

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Recent FDA Warnings For 11 Anesthesia Drugs May Be “Disservice to the Population”

questions over fda advice on anesthetics in childrenSome doctors feel that new warnings now required by the FDA on 11 anesthetic and sedation drugs may cause parents and guardians to needlessly put off life-altering or even life-saving procedures for their children. The warnings detail how extended use of the drugs might lead to brain damage. They apply to children aged three and younger, as well as pregnant women in their third trimester. The FDA has ...

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Tarceva Settlement Highlights Flaws in FDA Drug Approval Process

tarceva shows flaws in FDA approvalsIn June of 2016 Genentech, Inc issued a letter to doctors telling them to stop prescribing Tarceva, a lung cancer drug, to patients unless those patients presented with a specific gene mutation. A recent story in the Los Angeles Times details how the drug was showing only a 10 percent effectiveness rate in patients taking it, while simultaneously causing rashes all over those patient’s bodies.

Tarceva was designed to block ...

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FDA Cautions Against Excessive Anesthesia for Young Children

fda warns on anesthetics in childrenThe FDA is now requiring 11 anesthetic and sedation drugs to carry additional warnings on their labels because their extended use in young children might lead to brain damage. The warnings will apply to children aged three years and younger, as well as pregnant women in their third trimester.

Concern has slowly grown over using anesthetics during critical periods of brain development. Repeated use, as well as single sessions lasting longer than ...

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