Posts Tagged 'Food and Drug Administration'

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sales of opana halted by FDAEndo Pharmaceuticals has officially withdrawn Opana ER from the market at the FDA’s request.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

FDA Sued Over Resume Redactions

FDA sued over redacted resumes of committee membersDefense, intelligence, national security; these are all aspects of the federal government where one expects to see redactions in information released to the general public. We are all familiar with images of government documents with words, paragraphs, or even entire pages redacted, or “blacked out.”

Most of these documents are obtained through what are called FOIA requests, or Freedom of Information Act requests. In 1966, the ...

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