U.S. Food and Drug Administration

Women More Prone To Hip Implant Failure, Says Study

A new study suggests that women who underwent a hip replacement were 29 percent more likely than men to need a repeat surgery within the first three years.

Women More Prone To Hip Implant Failure, Says Study

A new study suggests that women who underwent a hip replacement were 29 percent more likely than men to need a repeat surgery within the first three years.

Zoloft Lawsuit Claims Drug is Ineffective

A lawsuit filed against drug giant Pfizer Inc. has claimed that its antidepressant drug Zoloft has no benefit for patients and that the company should refund patients for the costs of buying the drug.

Approvazione dell'FDA per lo scanner degli arti Planmed Verity®

Il 1° febbraio 2013 la U.S. Food and Drug Administration (FDA) ha pubblicato la lettera di approvazione 510(k) per lo scanner degli arti Planmed Verity®. Planmed Verity è destinato a essere utilizzato per la tomografia computerizzata radiografica e anatomica degli arti superiori e inferiori.

FDA clearance for Planmed Verity® Extremity Scanner

On February 1, 2013 the U.S. Food and Drug Administration (FDA) issued 510(k) approval letter for the Planmed Verity® Extremity Scanner. Planmed Verity is intended to be used for X-ray computed tomography of anatomies within upper and lower extremities.

Pradaxa Has Risks—Should You Take It?

Millions of Americans with an abnormal heart rhythm use the drug Pradaxa (dabigatran) daily to help prevent stroke and blood clotting. Since its approval in 2010, Pradaxa has been linked with numerous problems, including serious and potentially fatal bleeding. Pradaxa is not recommended for patients with mechanical heart valves or who are undergoing active bleeding.

Additionally, the Mayo Clinic provides warnings about the use of Pradaxa in other groups, including:

Feds Approve Pradaxa-like Drug

The U.S. Food and Drug Administration (FDA) gave the green light to a new blood thinner called Eliquis, which will be used to treat some patients with atrial fibrillation, an irregular heartbeat condition.

How Safe is Pradaxa?

In October 2010, the U.S. Food and Drug Administration (FDA) approved Pradaxa capsules (dabigatran etexilate) to prevent stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). Pradaxa replaced warfarin, an anti-coagulant drug that heart patients have used for decades.

Certainly, Pradaxa has saved lives—patients taking it suffered fewer life-threatening or major bleeds (including intracranial bleeds) than patients using warfarin. But does this mean taking Pradaxa is safe for all patients? Unfortunately, no.

How Safe is Pradaxa?

In October 2010, the U.S. Food and Drug Administration (FDA) approved Pradaxa capsules (dabigatran etexilate) to prevent stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation). Pradaxa replaced warfarin, an anti-coagulant drug that heart patients have used for decades.

Certainly, Pradaxa has saved lives—patients taking it suffered fewer life-threatening or major bleeds (including intracranial bleeds) than patients using warfarin. But does this mean taking Pradaxa is safe for all patients? Unfortunately, no.

Study Finds Incorrect Safety Labeling on Generic Drugs

A recent study found that most generic medications do not carry warnings identical to those on their brand-name equivalents despite a requirement that they do so from the U.S. Food and Drug Administration (FDA).

The study conducted by the Regenstrief Institute, which is affiliated with Indiana University, reveals that more than two-thirds of generic drugs have safety-warning labels that are not similar to the ones on the brand-name product.

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