FDA Slaps Bayer for Not Sharing Data on Trasylol Risks
October 2nd 2006ROCKVILLE, Md. -- The FDA said Bayer was not forthcoming with data from a retrospective study that suggested Trasylol (aprotinin injection) may increase the chance for death, serious kidney damage, congestive heart failure, and strokes.
Heart Rhythm Society Urges Tougher Post-Market Device Surveillance
September 28th 2006WASHINGTON -- The Heart Rhythm Society said today that the FDA should tighten up post-market surveillance of pacemakers and implantable cardioverter defibrillators (ICD). It would also ditch the word "recall" as not sufficiently specific.
Drug-Eluting Stent Safety Triggers Special FDA Advisory Panel
September 14th 2006ROCKVILLE, Md. -- The FDA said today that will convene a special meeting of an advisory committee to assess new data about "small but significant" increases in the rate of death and myocardial infarction among patients treated with drug-eluting stents.
Drug-Eluting Coronary Stents: Safety Concerns
September 14th 2006ROCKVILLE, Md. -- The FDA said today that will convene a special meeting of an advisory committee to assess new data about "small but significant" increases in the rate of death and myocardial infarction among patients treated with drug-eluting stents.
Survey: Would You Still Recommend Drug-Eluting Stents?
September 11th 2006Drug-eluting stents essentially eliminated short-term restenosis as a complication of coronary angioplasty, but suddenly the coated devices have come under a cloud for possible late term risks. This Medpage Today survey asks your opinion about the future use of drug-eluting stents. Additional Stent Coverage from ESC: Meta-Analyses Find Increased Death and MI with Cypher Stent Real World Trial Confirms Drug-Eluting Stents Better in Small Vessels Investigational Drug-Eluting Stent Superior to Taxus Drug-Eluting Stent Debate Develops Fever Pitch
ESC/WCC: World Congress of Cardiology Gets Call for Polypill for Secondary Prevention
September 3rd 2006BARCELONA, Spain -- The concept of a single pill packed with the potency of aspirin, statins, and ACE inhibitors-the triad proven to prevent a recurrent heart attack-got a powerful push at the opening of the World Congress of Cardiology here.
FDA May Grant Restricted OTC Approval for PlanB
July 31st 2006ROCKVILLE, Md. -- The FDA has suddenly signaled that it is ready, after three years, to move forward on limited over-the-counter status for Plan B, an emergency contraceptive. The move came the day before Andrew von Eschenbach, M.D., the acting FDA commissioner, is scheduled to testify before a Senate committee on his nomination as permanent FDA chief.
FDA Warns on Mixing Antidepressants with Migraine Drugs
July 20th 2006ROCKVILLE, Md. -- Mixing common migraine drugs such as Imitrex (sumatriptan) with antidepressants like Prozac (fluoxetine) or Cymbalta (duloxetine) can trigger a life-threatening condition called serotonin-syndrome, the FDA has warned.
FDA Approves First Drug for Parkinson's Dementia
June 28th 2006ROCKVILLE, Md. - The FDA has given Exelon (rivastigmine), already approved for treatment of mild-to-moderate Alzheimer's dementia, the added indication of mild-to-moderate Parkinson's dementia. It is the first agent approved for the Parkinson's condition.
Defibrillator Maker Recalls More than 350 Devices Sold in U.S.
June 16th 2006ROCKVILLE, Md. ? The FDA said today that 580 automatic external defibrillators, a model known as AED20, are being voluntarily recalled by MRL, a division of Welch Allyn, because of a malfunction that could result in failure to resuscitate patients.
FDA Approves First Drug for Treatment of Seasonal Affective Disorder
June 12th 2006ROCKVILLE, Md. - The FDA today approved Wellbutrin XL (bupropion extended release) for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). It is the first drug approved for SAD.
FDA Orders Unapproved Cold Remedies Pulled From Shelves
June 9th 2006ROCKVILLE, Md. ? In the opening salvo of an FDA initiative to cleanse the market of unapproved drugs, the agency has ordered some 120 cough and cold medicines that contain carbinomoxamine off store shelves. The two approved carbinomoxamine-containing products can continue to be sold.
FDA Approves Cervical Cancer Vaccine
June 8th 2006ROCKVILLE, Md. - The FDA today approved Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18] recombinant vaccine) for prevention of cervical cancer and for prevention of cervical, vulvar and vaginal pre-cancers caused by HPV types 16 and 18.