Posts Tagged 'FDA warning'

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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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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FDA Requires Benicar To Carry Enteropathy Warning

Benicar shown to cause diarrhea and weight lossThe U.S. Food and Drug Administration is investigating whether olmesartan-based blood pressure drugs Benicar, Azor, and Tribenzor increase the risk of enteropathy.

Benicar, known as olmesartan, an angiotensin II receptor blocker, was approved by the FDA on April 25, 2002, to treat high blood pressure. It is manufactured under the brand names Benicar, Benicar HCT, Azor, and Tribenzor.

Recently, the FDA issued a safety warning that Benicar, Azor, and Tribenzor can cause ...

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First Federal Transvaginal Mesh Claim Going to Trial

woman in pain due to transvaginal meshAn article from the Daily Report Online describes a woman in Georgia who filed the first federal claim against one of the Transvaginal mesh manufacturers. The claim against C.R. Bard detailed the health problems she’s endured as a result of receiving a vaginal mesh implant. She explains the Transvaginal mesh device was implanted to solve prior bladder problems, but it only made matters worse. She immediately sought medical help for ...

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FDA warns Samsca linked to liver injury

The U.S. Food and Drug Administration has issued a warning that the kidney drug tolvaptan, sold under the brand name “Samsca,” carries a risk of liver injuries, “potentially leading to liver transplant or death.”

According to a story on MedPage Today, the drug is used to treat low serum sodium levels.

Last January, the company that markets the drug, Otsuka American Pharmaceutical, notified physicians that it was linked to liver injury.

In a letter ...

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