Posts Tagged 'FDA'

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 ...

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The FDA’s New Year Resolution

fda to take active role in device error pattern predictionAs New Year’s Day came and went, millions of people across the country considered their resolutions for 2016. Statistically, most probably resolved to lose a few pounds. Others thought about reading more, taking a class or two, becoming more patient, or bettering themselves in some other way.

It looks like the FDA might have made a resolution or two of their own. And, among them, the federal ...

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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 ...

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As Benicar Lawsuits Top 1,000, Plaintiffs Ask: What Took So Long?

victims wonder why FDA action on Benicar took so longBenicar lawsuits consolidated in the New Jersey multidistrict litigation now exceed 1,000, and as more pour in, Benicar plaintiffs continue to ask: What took the U.S. Food and Drug Administration (FDA) so long to warn patients about the drug’s severe gastrointestinal side effects?

Daiichi Sankyo’s Benicar was approved by the FDA in 2002 to help treat patients with high blood pressure. It quickly became one of ...

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FDA Responds to Criticism Over OxyContin Decision for Children

fda responds to oxycontin criticismIn a decision that drew the ire of everyone from leaders in the medical community to members of Congress, the FDA recently approved the use of OxyContin for use in children as young as eleven years old.

An incredibly powerful opioid, OxyContin is highly addictive and can be lethal at high doses. And, when the nation is already in the throes of a prescription drug abuse and overdose crisis, the thought ...

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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 ...

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