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FDA Alerts

New Data Will Help Guide Prescribing of Celecoxib

  • Written by News Author: Lisa Nainggolan CME Author: Désirée Lie, MD, MSEd
  • Category: FDA Alerts
A new meta-analysis of six randomized trials involving the cyclooxygenase-2 (COX-2) inhibitor celecoxib (Celebrex, Pfizer) should help direct physicians who still want to prescribe this drug [1]. Dr Scott D Solomon (Brigham and Women's Hospital, Boston, MA) presented the findings of the cross-trial safety analysis at a late-breaking trials session here at the American College of Cardiology 57th Annual Scientific Session, and they were published simultaneously in Circulation.

Read more: New Data Will Help Guide Prescribing of Celecoxib

Blood Substitutes Linked to Deaths, MI; FDA Should Have Acted Sooner to Stop Trials, Researchers Say

  • Written by News Author: Shelley Wood CME Author: Laurie Barclay, MD
  • Category: FDA Alerts
People treated with blood substitutes in clinical trials over the past two decades were 30% more likely to die and had almost a threefold higher rate of myocardial infarction (MI) than patients in control groups, a new meta-analysis suggests [1]. Even more damning, the authors of the study say that the US Food and Drug Administration (FDA) had ample evidence eight years ago to put a stop to ongoing studies of hemoglobin-based blood substitutes (HBBS) — some of which were used in cardiac surgery trials — but did not.

Read more: Blood Substitutes Linked to Deaths, MI; FDA Should Have Acted Sooner to Stop Trials, Researchers Say

AHA Statement Takes Aim at Hypertension Resistant to Triple-Drug Therapy

  • Written by Steve Stiles
  • Category: FDA Alerts
News Author: Steve Stiles
CME Author: Charles Vega, MD
A new statement from the American Heart Association zeroes in on a group it says may make up 20% to 30% of patients with hypertension but has received only limited attention in formal guidelines, probably because they have been targeted in few clinical trials [1]. The document defines the group, patients with "resistant" hypertension, as those whose blood pressure (BP) remains above goal despite concurrent therapy with three distinct agents or who need at least four such drugs to achieve control.

Read more: AHA Statement Takes Aim at Hypertension Resistant to Triple-Drug Therapy

All drugs containing PHENYLPROPANOLAMINE are being recalled

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts

All drugs containing PHENYLPROPANOLAMINE are being recalled.

STOP TAKING anything containing this ingredient. It has been linked to increased hemorrhagic stroke (bleeding in brain) among women ages
18-49 in the three days after starting use of medication. Problems were not found in men, but the FDA recommended that everyone (even children) seek alternative medicine.

The following medications contain Phenylpropanolamine:


Read more: All drugs containing PHENYLPROPANOLAMINE are being recalled

FDA Goes After 'Natural' HRT Claims

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
Todd Zwillich
Federal regulators warned several pharmacy companies Wednesday to stop marketing so-called "natural" hormone replacement therapy, calling their sales to women "false and misleading."

The FDA took aim at seven compounding pharmacy companies that it says use a product called estriol in reformulated hormone replacement therapy for women.

Read more: FDA Goes After 'Natural' HRT Claims

FDA Safety Changes: Pexeva, Vfend, Suprane

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
News Author: Yael Waknine
CME Author: Yael Waknine
The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the risk for serotonin syndrome in patients receiving concomitant treatment with paroxetine mesylate and triptans, drug interactions between voriconazole and efavirenz requiring dose adjustments for both drugs when used concomitantly, and the risk for respiratory adverse events associated with use of desflurane in certain pediatric settings.
Concomitant Use of Paroxetine Mesylate (Pexeva) and Triptans Linked to Risk for Serotonin Syndrome

Read more: FDA Safety Changes: Pexeva, Vfend, Suprane

FDA Warns of Counterfeit Prescription Drugs Purchased Online

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
Yael Waknine
The US Food and Drug Administration (FDA) is warning consumers and healthcare professionals of the risk for obtaining counterfeit drugs when purchasing prescription medications online, according to a news release.

Read more: FDA Warns of Counterfeit Prescription Drugs Purchased Online

FDA MedWatch: Welch Allyn AED 10 Automatic External Defibrillators

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
FDA MedWatch: Welch Allyn AED 10 Automatic External Defibrillators manufactured between 3/29/07 and 8/9/07 - Class 1 Recall

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA issued a Class I recall for Welch Allyn AED 10 Automatic External Defibrillators manufactured between March 29, 2007 and August 9, 2007, part numbers 970302E, 970308E, 970310E, and 970311E. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training in cardiopulmonary arrest (heart attack). They analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.

Read more: FDA MedWatch: Welch Allyn AED 10 Automatic External Defibrillators

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