Endo Pharmaceuticals has officially withdrawn Opana ER from the market at the FDA’s request. The extended release opioid medication recently became the subject of an inquiry by the agency because of the specific way it was being abused.
Opana ER was designed to slowly and steadily medicate a patient as an extended release medication. However, when crushed, snorted, or injected, an abuser can get the full dose ...
continue reading...Congress is planning to vote on a deal between the medical device industry and the FDA that could come at great risk to consumers, according to the New York Times. The agreement between the two parties is renegotiated every five years and focuses heavily on the fees that medical device companies pay the agency to review their products.
The most concerning part of the proposed agreement ...
continue reading...The 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 ...
continue reading...A 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 ...
continue reading...The 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 ...
continue reading...Some 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 ...
