Tag Archives: identification

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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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Cancer Groups Call for E-cigarettes Regulation/Research

Two Leading Cancer Groups Issue Call for Regulation of E-cigarettes and Research on Health Risks

In a joint statement, the American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects. These leading research and treatment organizations asked the Food and Drug Administration (FDA) to make ...

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Federal DePuy ASR Hip Implant Trials Likely to Start This Year

It looks as though the first trials in the DePuy ASR hip implant multidistrict litigation could begin sometime later this year. According to a report from Bloomberg News, during a status conference held yesterday in Florida, attorneys for both plaintiffs and the defense told U.S. District Judge David Katz that ...

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Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Cancer Groups Call for E-cigarettes Regulation/Research

Two-Leading-Cancer-Groups-Issue-Call-for-Regulation-of-E-cigarettes-and-Research-on-Health-Risks

The American Society of Clinical Oncology & the American Association for Cancer Research called for government regulation & research of e-cigarettes on health effects.

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects ...

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Google Searches Could Help FDA Identify Drug Side Effects

Google Searches Could Help FDA Identify Drug Side Effects

The Food and Drug Administration (FDA) has asked for Google’s help in identifying previously unknown side effects of medications. Last month, in a conference call, FDA officials spoke with a senior Google researcher who co-authored a 2013 paper about using search query … Continue reading

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