Posts Tagged 'FDA'

FDA Issues Safety Announcement for New Liver Disease Drug

fda issues statement on OcalivaBloomberg reports that the FDA has issued a safety announcement for Intercept’s Ocaliva, a drug designed for a rare liver disease known as primary biliary cholangitis. The announcement comes after at least 19 deaths were attributed to the medication, which was only introduced in May of 2016.

Intercept claims to have explicitly warned doctors of the specificity with which they must prescribe Ocaliva and how it must be taken by patients. ...

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Forbes Analysis: Danger Warnings Make Invokana Harder to Sell

investors weary of invokanaThe analysis is in: people are less likely to buy a medication when they’ve been warned that it may increase the odds of them having their leg or foot amputated. And, while this is bad news for Invokana specifically, Forbes would like you to know that Johnson & Johnson – the drug’s manufacturer – will be just fine.

This is the gist of an article that appeared on the Forbes website ...

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Opana ER Pulled from Shelves Over Abuse Concerns

sales of opana halted by FDAEndo Pharmaceuticals has officially withdrawn Opana ER from the market at the FDA’s request.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 in a ...

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Deal Between FDA, Medical Device Makers Could Put Consumers At Risk

FDA and drug makers renegotiate reporting agreementCongress 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 comes in ...

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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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