FDA & Prescription Drugs

• FDA Issues Early Communication to Pfizer for the Drug Chantix

  Chrissie Cole | November 22, 2007 12:30 AM | 0 CommentsMobile, AL

  Chantix, a prescription drug aide to help adults quit smoking, is being evaluated by the FDA for adverse health effects.Pfizer Inc., the manufacturer, recently submitted reports to the FDA describing suicidal ideation (thoughts). In the aftermath of a recent case that reported erratic behavior while taking Chantix, the FDA also requested any additonal information on cases with any...

• GSK Agrees to "Black Box" Warning for Avandia Heart Attack Risk

  Chrissie Cole | November 14, 2007 11:49 PM | 0 CommentsMobile, AL

  Today, the U.S. Food and Drug Administration announced - GlaxoSmithKline (GSK), manufacturer of the popular type 2 diabetes drug, Avandia, has agreed to add new warning information to the existing boxed warning about the potential risk for heart attacks.People who suffer from type 2 diabetes that have heart disease or who are at high risk of heart attack should talk with their medical doctor...

• Revision of PDE5 Inhibitors to Include Risk of Hearing Loss

  Jenny Albano | October 20, 2007 3:09 PM | 0 CommentsMobile, AL

  The FDA has announced that it is going to add a label to include the risk of hearing loss for the erectile dysfunction (ED) drugs Cialis, Levitra, and Viagra and to Revatio, which is used to treat pulmonary arterial hypertension (PAH). The new labeling will display more prominently the potential risk of sudden hearing loss, and a guide for consumers on what to do if they experience sudden...

• Ultrasound Contrast Agents To Get FDA Warnings

  Courtney Mills | October 09, 2007 12:37 PM | 0 CommentsMobile, AL

  The federal government is planning on requiring warnings for certain contrast agents used with ultrasound technology. These contrast agents are used to improve diagnoses of heart problems in patients evaluated with ultrasound imaging equipment.The contrast agents are sold under the brand name Definity, by Bristol-Myers Squibb, and Optison, of General Electric. Physicians inject the imaging...

• MRI Gadolinium Contrast Agents Get Black Box Warning

  Courtney Mills | October 02, 2007 9:45 AM | 0 CommentsMobile, AL

  The U.S. FDA indicated that it would start adding its strongest 'black box' warnings to gadolinium based contrast agents used in MRIs by May of next year. There are five different types of gadolinium based contrast agents, and the FDA has evidence enough to suggest a causal connection between the agents and a skin condition called nephrogenic systemic fibrosis (NSF) in patients with impaired...

• FDA Issues Warnings on Schizophrenia Drug Haldol

  Courtney Mills | September 18, 2007 10:34 AM | 0 CommentsMobile, AL

  The FDA issued serious new warnings about Johnson and Johnson's schizophrenia drug Haldol, generically known as haloperidol. The drug was reported to have caused several life-threatening heart conditions in patients using the medication at higher than recommended dosages or taking the drug intravenously, which is not an FDA recommended use for haloperidol.Haldol is reported to have caused...

• Study shows increase in drug deaths reported to FDA

  Staff Writer | September 17, 2007 12:24 PM | 0 CommentsMobile, AL

  The Chicago Tribune reported that a new study published in the Archives of Internal Medicine showed a big increase in the number of drug deaths and injuries reported to the FDA between the years of 1998 and 2005. This may shed some light on recent problems that have arisen with the government agency that monitors prescription and over-the-counter drugs.The sudden increase in "adverse events"...

• Study Suggests Actos Protects Heart, But Avandia Does Not

  Jenny Albano | September 11, 2007 11:37 PM | 0 CommentsMobile, AL

  A study published on Tuesday, September 11, found that Actos, a type 2 diabetes drug, reduces the risk of heart attack, stroke and death, but may raise the risk of heart failure. According to another study, Avandia, another diabetes drug, increases the risk of heart attack and heart failure significantly.Actos lowered the risk of heart attack, stroke and overall death by 18 percent, while...

• FDA Issues Warnings on Warfarin

  Courtney Mills | August 17, 2007 1:50 PM | 0 CommentsMobile, AL

  The FDA has issued health warnings on the use of blood thinners in certain individuals. Warfarin, an anticoagulant agent, is prescribed by doctors in the United States to patients who have heart trouble or irregular heartbeats.Warfarin is popularly marketed under the prescription brand name Coumadin, and has demonstrated severe complications in patients of certain genetic make-up. These...

• Vioxx Heart Attack Risk Begins Earlier

  Jenny Albano | July 03, 2007 11:17 AM | 0 CommentsMobile, AL

  A new study, approved for publication in the New England Journal of Medicine found that heart risks from the drug Vioxx began much sooner than Merck & Co. stated. The FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.Vioxx was pulled from the market after an FDA-funded study found that the drug doubled the risk of heart attack after 18 months of...