FDA & Prescription Drugs

• Subpoenas Issued Over Ketek

  Shannon Weidemann | January 31, 2008 10:02 AM | 0 CommentsMontgomery, AL

  The Congressional subcommitte Oversight and Investigations will be issuing subpoenas to FDA investigators over the antibiotic Ketek. They are looking for more information into fraudulant clinical data that was used to gain approval for the drug. Last year the FDA issued a black box warning label for Ketek, the highest safety warning. The subcommittee is investigating drug safety and whether...

• Vytorin No Better than Older Drug

  Shannon Weidemann | January 18, 2008 10:27 AM | 0 CommentsMontgomery, AL

  A study performed by Merck & Co. over two years ago showed that Vytorin, a cholesterol lowering and statin drug did not effectively reduce the amount of fatty deposits in arteries. Vytorin is a combination of Zetia, a cholesterol lowering drug, and Zocor, a statin. The study concluded that Zocor and Vytorin had the same affect on fatty deposits. There has been confusion over what that means...

• FDA Approves Update to Ortho Evra Patch Label

  Chrissie Cole | January 18, 2008 12:39 AM | 0 CommentsMobile, AL

  The U.S. Food and Drug Administration (FDA) has approved revisions to the current Ortho Evra Contraceptive Patch label. The updated labels will reflect results from a new study that found users of the patch were at an increased risk of developing serious blood clots (also known as (VTE - venous thromboembolism), than those women who use birth control pills.The study was conducted by Boston...

• FDA Warns About False Claims for Some Menopause Therapy Drugs

  Chrissie Cole | January 09, 2008 11:00 PM | 0 CommentsMobile, AL

  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...

• Blood Sugar Test Strips Recalled

  Shannon Weidemann | December 28, 2007 7:39 PM | 0 CommentsMontgomery, AL

  Test strips used by diabetics to test their blood sugar levels have been recalled after it was discovered they were giving false readings. The recalled test strips were manufactured by Bayer and are used with the Contour TS blood glucose meter. The test strips in question are sold predominately through mail order to be used only with the Contour TS meter. The recall covers seven countries --...

• Merck Recalls 1 Million Doses Of Childhood Vaccine

  Chrissie Cole | December 13, 2007 12:30 AM | 0 CommentsMobile, AL

  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...

• Merck Recalls HIB Vaccine

  Shannon Weidemann | December 12, 2007 7:38 PM | 0 CommentsMontgomery, AL

  It was announced today that Merck is recalling 1.2 Million doses of its HIB and Comvax vaccine. The recalled vaccines are used to prevent pnuemonia, meningitis, and hepatitis B and are generally injected into children under the age of five. The plant were the vaccines are manufactured is contaminated, although Merck has not said with what. The recall involves 11 lots of a Hib vaccine,...

• 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...