FDA Reclassifies Surgical Mesh for Pelvic Organ Prolapse as ‘High Risk’

The FDA has reclassified surgical mesh used to repair pelvic organ prolapse as “high risk,” citing thousands of reports of complications involving its use. The classification requires manufacturers to complete a rigorous application process demonstrating the safety and effectiveness of the implant. Companies with products already on the market have 30 months...
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Olympus played down early report of superbug infections linked to duodenoscope devices

Earlier this year, Olympus came under fire after its duodenoscope devices were implicated in superbug outbreaks at medical centers in the U.S. But the company's questionable practices regarding the products date further back, as Olympus played down an early report of a superbug outbreak linked to its device overseas.

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F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs

WASHINGTON — Inaccurate and unreliable medical tests are prompting abortions, promoting unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs, the Food and Drug Administration has concluded.

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Risk of Off-Label Uses for Prescription Drugs

About 12% of drugs doctors prescribe are for uses other than those approved by regulators, a recent study found. So-called off-label prescribing significantly raises the rate of negative side effects, the research showed.

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Makers of Nutritional Supplements Charged in Federal Sweep

A yearlong federal investigation into the dietary supplement industry has resulted in a widespread crackdown on the sale of tainted or misleading products.

The Justice Department said on Tuesday that it filed criminal and civil enforcement actions against 117 companies and individuals.

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AbbVie’s Hepatitis C Drugs Label Changed After Patient Deaths

Seven patients on AbbVie Inc.’s drugs for hepatitis C died after liver failure, prompting U.S. regulators to change their advice on how the medicine should be administered.

Doctors should monitor patients using Viekira Pak or Technivie for signs of worsening liver disease, the U.S. Food and Drug Administration said in a statement Thursday. The medication...

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FDA staff reviewers question safety of AstraZeneca’s gout drug

(Reuters) - Staff reviewers of the U.S. Food and Drug Administration have raised questions about the safety of AstraZeneca Plc's gout treatment.

Reviewers pointed to higher death rates, cardiovascular issues and kidney-related side effects in patients who took the drug, lesinurad, a preliminary review published on Wednesday showed.

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Lawmakers push ban on herbal Viagra after Odom’s overdose

ALBANY — Lamar Odom’s near-deadly binge on drugs, hookers and herbal sex supplements has moved two state lawmakers to take a hard look at stopping so-called herbal Viagra.

“This incident raises serious concerns about FDA enforcement of prescription drugs,” said state Sen. Jeff Klein (D-Bronx).

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