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Chrissie Cole

FDA Warns About False Claims for Some Menopause Therapy Drugs

The FDA has sent warning letters to seven pharmacies ,within the last week regarding false or misleading claims about their made-to-order products, commonly marketed as bio-identical hormone replacement therapy (BHRT).The FDA has also agreed to create public-awareness campaigns designed to dispel myths about “bio-identicals.”Some pharmacies that make “bio-identicals” say they are all-natural and…

Chrissie Cole

Merck Recalls 1 Million Doses Of Childhood Vaccine

Merck & Co., a popular drug manufacturer, announced a recall of more than one million vaccines due to a contamination risk. U.S. Health officials say the recall is not a health threat. Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference.The recalled vaccine, HIB, is used to protect babies and children from meningitis and pneumonia. Merck…

Chrissie Cole

FDA Issues Early Communication to Pfizer for the Drug Chantix

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…

Chrissie Cole

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

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…

Jenny Albano

Revision of PDE5 Inhibitors to Include Risk of Hearing Loss

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…

Courtney Mills

Ultrasound Contrast Agents To Get FDA Warnings

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…

Courtney Mills

MRI Gadolinium Contrast Agents Get Black Box Warning

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…

Courtney Mills

FDA Issues Warnings on Schizophrenia Drug Haldol

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…

Staff Writer

Study shows increase in drug deaths reported to FDA

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”…

Jenny Albano

Study Suggests Actos Protects Heart, But Avandia Does Not

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…