FDA & Prescription Drugs

• Let the FDA Do Its Job? I Don't Think So.

  Linda Snyder | May 02, 2008 1:49 PM | 0 CommentsDenver, CO

  What planet does Diane Bieri live on? It’s certainly not on the planet earth that I live on. In her commentary, Opposing view: Let FDA do its job, Ms. Bieri goes on and on about how the outcome of a...

• Pharmaceutical Companies Spend Twice as Much on Marketing than on Research and Development

  Linda Snyder | March 11, 2008 7:42 PM | 0 CommentsDenver, CO

  PLOS Medicine, an online medical journal conducted a study using numbers from 2004 and concluded that pharmaceutical companies spent almost twice as much on marketing than on their research and development for their United States markets.As a marketing person, on the one hand I am in awe of these marketing budgets, in excess of $57.5 billion dollars. But as a consumer, I'm a bit dismayed that...

• So what is an MDL?

  Staff Writer | April 19, 2006 9:31 AM | 2 CommentsDenver, CO

  Many folks have recently seen or perhaps heard of the Vioxx, Celebrex, Bextra, Ortho Evra, Guidant and Medtronic "MDLs" in the media. So what is an "MDL"? Well, its shorthand for multidistrict litigation. The first thing you need to know about multidistrict litigation is that its not the same thing as a class action. A class action is a lawsuit where a few people sue on behalf of themselves and...

• What is Alexidine?

  Staff Writer | May 10, 2006 10:20 PM | 0 CommentsDenver, CO

  Alexidine is a disinfectant that traditionally has been used in mouthwash solutions. Its first use in contact lens solutions was in ReNu with MoistureLoc, thus it is a "new" product in this arena. It is believed that Alexidine is the cause or is a partial cause of the problems with this product. The current theory is that ReNu with MoistureLoc does not have sufficient disinfectant efficacy --...

• Fentanyl Patches Made by Actavis Recalled

  Jenny Albano | February 19, 2008 12:11 AM | 0 CommentsDenver, CO

  Actavis Inc., in conjunction with the FDA, is recalling 14 lots of its Fentanyl transdermal system CII patches because the patches have a defect that can cause them to leak. The Fentanyl patches were available from wholesalers and pharmacies throughout the United States. Fentanyl patches sold in Europe are not affected by this recall.The 14 lots of Fentanyl transdermal system patches being...

• The Heparin Debacle Part Four – Baxter International Getting Away with Murder?

  Linda Snyder | May 07, 2008 4:42 PM | 0 CommentsDenver, CO

  Getting away with murder? That’s a pretty harsh question to ask when talking about a drug company. But, I question the policy of drug maker, Baxter International to leave a product on the market for...

• Litigation Update - Zicam/Cold-Eeze Nasal Sprays Cause Loss of Smell/Taste

  Staff Writer | March 09, 2006 7:47 PM | 0 CommentsDenver, CO

  Burg Simpson is currently interviewing potential clients with cases involving two homeopathic remedies that have been shown to injure users. The two drugs are (a) Zicam Cold Remedy Nasal Gel and (b) Cold-Eeze Nasal Spray. Both are cold remedies, that are sprayed directly into the user's nose. The active ingredient in each is zinc (in the form of zinc gluconate). Zinc ions have long been...

• Ortho Evra Heat Precautions

  Staff Writer | January 16, 2007 6:20 PM | 0 CommentsDenver, CO

  It was already know that Ortho Evra can cause blood clots. Now the maker of the patch is saying that overweight women using the patch are at a particularly high risk of developing blood clots. Janssen-Ortho Inc. (subsidiary of Johnson & Johnson) also warns that women should not expose the Ortho Evra patch to sources of heat such as saunas and whirlpools. The company believes there is a...

• New Rules on Prescription Drug Preemption

  Staff Writer | July 04, 2006 8:44 PM | 0 CommentsDenver, CO

  New FDA labeling regulations were effective June 30, 2006. Announced January 18, 2006, these regulations, 21 CFR 201, 314 and 601, have the claimed purpose of providing new labeling guidelines for prescription drugs, to make drug labeling easier to read and understand and to include requirements to highlight certain information and to promote minor changes in graphics and content of drug...

• Recent Activity Relating to ReNu with MoistureLoc

  Staff Writer | May 12, 2006 10:23 PM | 0 CommentsDenver, CO

  On April 10, 2006 (updated: April 21, 2006), Daniel G. Schultz, M.D., Director Center for Devices and Radiological Health (part of the FDA), signed a Dear Healthcare Practitioner letter (Preliminary Public Health Notification-Fungal Keratitis Infections Related to Contact Lens Use, available at http://www.fda.gov/cdrh/safety/041006-keratitis.html). It provided updated information on the recent...