Posts Tagged 'FDA'

Essure Faces New U.S. Restrictions

essure facing new sales restrictions in U.S.The sale and implantation of Essure in the United States is facing a new set of federally-mandated restrictions, and the government has left the enforcement of that mandate to the company that manufactures the device being restricted.

In response to a decline in demand for its female sterilization solution that quite literally spans the globe, Bayer ceased sales of Essure in every market on the planet except the United States late ...

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In the Absence of Safety Warnings, Actemra May Have Killed Hundreds

rheumatoid arthritis drug actemra may be responsible for hundreds of deathsAs horrible as it can be to endure a life with rheumatoid arthritis, the side effects of the drugs most commonly associated with the treatment of the condition are equally, if not more terrible. In an analysis of more than half a million side effect reports from these medications, clear patterns emerged that indicate strong links to heart attacks, strokes, and heart failure.

Actemra was marketed with ...

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sales of opana halted by FDAEndo Pharmaceuticals has officially withdrawn Opana ER from the market at the FDA’s request.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