Posts Tagged 'Food and Drug Administration'

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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A Black Box Warning for Essure? Finally.

essure finally gets black box warningIn what many would consider a long overdue move, the FDA has recommended a black box warning for Bayer’s Essure contraceptive device. The move comes after an ongoing public outcry and an FDA hearing last fall. The black box warning, if it does indeed make it to the Essure label, is the strongest warning that can be placed by the FDA and is designed to call attention ...

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Manufacturers May Have Under-Reported Duodenoscope Infection Rates

duodenoscope infection rates may have been under-reportedThe bacterial infections attributed to non-sterile duodenoscopes that sickened and killed patients in hospitals in California and Washington last year may have represented just a small fraction of the total number of cases.

A report issued by the United States Senate accuses device manufacturers of failing to report infections within the required 30-day guideline. Such a failure would lead to artificially low numbers.

Washington Senator Patty Murray launched ...

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FDA Warns Hepatitis C Drugs Can Cause Serious Liver Injury

hepatitis c drugs may cause liver damageThe U.S. Food and Drug Administration (FDA) recently issued a safety communication warning that the hepatitis C treatments Viekira Pak and Technivie may cause serious liver injury, especially in patients with advanced liver disease. Accordingly, the agency has requested that the drugs’ manufacturers add information about this risk to their products’ safety labels.

Viekira Pak and Technivie, both produced by pharmaceutical giant AbbVie, are used to treat ...

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FDA: DPP-4 Inhibitors Like Januvia May Cause Severe Joint Pain

fda issues warning on DPP-4 inhibitorsThe U.S. Food and Drug Administration (FDA) has issued a safety communication warning that certain type 2 diabetes drugs, called dipeptidyl peptidase-4 (DPP-4) inhibitors, may lead to severe joint pain in patients taking them. Among the diabetes drugs named in the announcement are Merck’s Januvia (sitagliptin) and AstraZeneca and Bristol-Myers Squibb’s Onglyza (saxagliptin); as well as Incretin mimetic drugs containing linagliptin or alogliptin.

Januvia was approved by the FDA ...

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FDA Suggests Black Box Warnings for Victoza and Bydureon

victoza and bydureon may get black box warningsA pair of letters sent out in March by the FDA suggest that Novo Nordisk and AstraZeneca include black box warnings on the labels of their diabetes drugs, Victoza and Bydureon. The letters refer to previous notices sent by the FDA suggesting that the pharmaceutical companies include information about “the risk of medullary thyroid carcinoma” posed by the drugs. Accordingly, both Victoza and Bydureon now ...

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