FDA & Prescription Drugs

• Regranex Use May Increase Risk of Cancer

  Chrissie Cole | March 30, 2008 8:44 PM | 0 CommentsNew York City, NY

  The U.S. Food and Drug Administration (FDA) is researching data that shows an increased risk of cancer, in diabetic patients who use Regranex Topical Gel (becaplermin) for the treatment of foot and leg ulcers.The FDA received information from a study that was performed to investigate the possibility of increased cancer risk in connection with use of Regranex.The study was based on diabetic...

• FDA Issues Alert on Tussionex

  Chrissie Cole | March 11, 2008 12:37 AM | 0 CommentsNew York City, NY

  The FDA has issued a safety alert regarding the proper use of Tussionex Extended-Release Suspension, a potent long acting prescription cough medication, following several reports of adverse events - including death - associated with inappropriate use.The medication contains hydrocodone (a narcotic) and chlorpheniramine (an antihistamine) and is prescribed for use in adults and children six years...

• FDA Warns of Contaminated Syringes

  Chrissie Cole | January 25, 2008 12:38 AM | 0 CommentsNew York City, NY

  The U.S. Food and Drug Administration (FDA) announced a nationwide drug recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc. under the brand name(s) Sierra Pre-filled, Inc. and B. Braun. The recall was announced after samples tested positive for Serratia marcescens, a bacterium that can cause death and serious injury. Serratia marcescens has been...

• Antidepressants Have Little Effect

  Shannon Weidemann | January 20, 2008 10:23 AM | 0 CommentsNew York City, NY

  A study in the New England Journal of Medicine is reporting that many antidepressants do not work. The antidepressant study was performed by researchers at Oregon Health and Science University. They based their data on 74 studies that had been submitted to the FDA. The study shows that of the 74 studies registered with the Food and Drug Administration from 1987 through 2004, 38 were deemed...

• Trasylol License Suspended

  Shannon Weidemann | December 21, 2007 12:01 PM | 0 CommentsNew York City, NY

  The anti-bleeding drug Trasylol was recalled in early November after a study revealed the risk of death was 50 percent higher than on other drugs. The BART study examined results on over 3,000 patients that had been given Trasylol and two similar drugs. The Commission on Human Medicine decided this week to suspend Trasylol's license. The CHM decision to suspend the licence was made on the...

• Sierra Heparin Syringes Recalled

  Shannon Weidemann | December 19, 2007 9:54 PM | 0 CommentsNew York City, NY

  Pre-filled syringes manufactured by Sierra Pre-Filled have been recalled after being contaminated with Serratia marcescens. The recalled syringes had sicked approximately 40 people in two states. It is not known if the contaminated item was the syringe or the Heparin contained in them. Syringes from that batch also were sent to Colorado, Florida and Pennsylvania but infections so far have...

• HPV Vaccine Linked to Paralysis

  Shannon Weidemann | November 14, 2007 9:48 PM | 0 CommentsNew York City, NY

  The vaccine Gardasil was introduced last year as a way to combat cervical cancer in women. It works by preventing an infection with Human Papilloma Virus (HPV). Now there are reports of girls having adverse affects after receiving the vaccine. One such report is from the family of a 12-year-old girl in Florida that had paralysis in one leg two weeks after receiving the first injection. The...

• Bayer Stops Selling Trasylol

  Shannon Weidemann | November 05, 2007 8:51 PM | 0 CommentsNew York City, NY

  The blood clotting drug Trasylol will no longer be sold by Bayer AG after studies have shown there is an increased risk of death from using the drug. The recalled drug increases the risk of kidney damage when used during heart bypass surgery. The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA's...

• Dialysis Cartridge Recalled Due to Leakage

  Shannon Weidemann | August 29, 2007 3:10 PM | 0 CommentsNew York City, NY

  Dialysis cartridges used in the NxStage's System One portable dialysis machine have been recalled due to potential dialysate leaks. The dialysis machines are used in 265 clinics around the country. After discussing the leakage issue with the U.S. Food and Drug Administration, NxStage said in the SEC filing that it decided on August 24 to physically recall the affected lots of cartridge...

• FDA Letter May be Evidence in Zyprexa Lawsuits

  Shannon Weidemann | July 12, 2007 1:54 PM | 0 CommentsNew York City, NY

  The FDA issued a letter to Eli Lilly requesting more information about their drug Symbyax before approving it for a new use. Symbyax is a combination of Prozac and Zyprexa. Zyprexa is currently the subject of several state-led class action lawsuits due to underreported side effects and marketing of the drug for uses not approved by the FDA. The FDA made its request for more information on...