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Vioxx (rofecoxib) Questions and Answers | FDA
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/vioxx-rofecoxib-questions-and-answers
FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck & Co., Inc. voluntarily withdrawing Vioxx from the market due to safety concerns. 5.
FDA Tried To Thwart Release Of Vioxx Data - Parker ...
https://www.yourlawyer.com/defective-drugs/fda-defective-drugs/fda-tried-thwart-release-vioxx-data/
FDA Tried To Thwart Release Of Vioxx Data. Posted: January 4, ... shortly before Graham presented the data at a scientific conference in France two months ago. The official wrote Merck “needs to know before it becomes public, so they can be prepared for extensive media attention that this will likely provoke.” ... The committees are looking ...
VIOXX® - Food and Drug Administration
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21647_vioxx_lbl.pdf
VIOXX Tablets 12.5 mg and 25 mg are bioequivalent to VIOXX Oral Suspension 12.5 mg/5 mL and 25 mg/5 mL, respectively. Food and Antacid Effects Food had no significant effect on either the peak plasma concentration (C max) or extent of absorption (AUC) of rofecoxib when VIOXX Tablets were taken with a high fat meal. The time to peak plasma
Drug Approval Package: Vioxx (Rofecoxib) NDA# 021042 & 021052
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021042_52_Vioxx.cfm
Vioxx (Rofecoxib) TabletsCompany: Merck Research LaboratoriesApplication No.: 021042 & 021052Approval Date: 5/20/1999. Approval Letter (s) (PDF) (1 MB) Final Printed Labeling (PDF) (3 MB) Medical Review (s) Part 1 (PDF) (2.4 MB)
FDA Official Admits ‘Lapses’ on Vioxx – FDA Didn’t Heed ...
https://ahrp.org/fda-official-admits-lapses-on-vioxx-fda-didnt-heed-warnings-on-dangers-of-ms-drug/
F.D.A. Official Admits ‘Lapses’ on Vioxx By GARDINER HARRIS WASHINGTON, March 1 – After the Food and Drug Administration insisted for months that it did nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged “lapses” in the agency’s actions before a Senate panel on Tuesday.
Sen Grassley Expands Investigation – Why did FDA …
https://ahrp.org/sen-grassley-expands-investigation-why-did-fda-approve-vioxx-for-children/
The FDA’s own study of the Vioxx safety issue has become mired in controversy. The FDA safety officer in charge of the report, David Graham, concluded that Vioxx posed much greater cardiovascular risk than the other major drug in its class, Celebrex. He presented that information at a French conference this summer.
Timeline: The Rise and Fall of Vioxx : NPR
https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and-fall-of-vioxx
A timeline of Vioxx's rise and fall: November 1998: Merck asks the Food and Drug Administration (FDA) for approval of Vioxx, having tested the drug on 5,400 subjects in eight studies. January 1999 ...
Vioxx Shows: FDA Unable To Protect Public From Deadly ...
http://www.newmediaexplorer.org/sepp/2004/11/23/vioxx_shows_fda_unable_to_protect_public_from_deadly_medical_drugs.htm
22 November 2004. ( see the original here) Several scientists testifying before the Senate Finance Committee on November 17 provided substantial evidence that the drug company Merck and the US Food and Drug Administration (FDA) knew of safety problems years before the drug Vioxx was withdrawn from the market.
Whistleblowers reveal FDA exacerbated Vioxx scandal
https://www.outsourcing-pharma.com/Article/2005/05/30/Whistleblowers-reveal-FDA-exacerbated-Vioxx-scandal
Vioxx (rofecoxib), used by millions worldwide to treat arthritis was withdrawn from the market last September after comprehensive clinical data confirmed long-established concerns that the treatment increased the risk of heart attacks and strokes. Its withdrawal sent a powerful message regarding safety over similar drugs in the same class.
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