FDA & Prescription Drugs

• 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...

• Cases of Fusarium keratitis associated with ReNu with MoistureLoc

  Staff Writer | May 11, 2006 10:21 PM | 0 CommentsDenver, CO

  Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in November 2005. See http://www.aoa.org/x5161.xml. In February 2006, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions both in Singapore and Hong Kong. On March 8, 2006, The Centers for Disease Control and Prevention ("CDC") received a report from an ophthalmologist in New...

• 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 --...

• What is Fusarium Keratitis?

  Staff Writer | May 09, 2006 10:19 PM | 0 CommentsDenver, CO

  Fungal keratitis is an extremely serious eye infection that can develop through the whole depth of the cornea. The infection can require prolonged drug therapy with antifungals such as natamycin or nystatin. If drugs do not work and the eye is damaged, surgery may be necessary to remove fungal ulcers and/or lesions, or to implant a shell to preserve the shape and structure of the eye. Symptoms...

• ReNu with MoistureLoc products and fungal keratitis infections caused by Fusarium fungus

  Staff Writer | May 08, 2006 10:17 PM | 0 CommentsDenver, CO

  What is ReNu with MoistureLoc?ReNu with MoistureLoc first became commercially available in the United States in 2004. It is a daily use contact lens solution that according to the package insert is used in "the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses." Users are directed to soak their contact lenses...

• Tequin Exiting Market

  Staff Writer | May 05, 2006 8:06 PM | 0 CommentsDenver, CO

  Bristol-Myers Squibb Co. will stop making and selling its antibiotic Tequin, but existing supplies will remain in place and will not be recalled. Tequin's safety has been in question, and the FDA increased warnings on the drug's label in February. The drug is suspected of causing both high and low blood sugar in some patients; and the manufacturer has warned that diabetics shouldn't use it,...

• Vioxx Risks Can Occur within Two Weeks, Says New Study

  Staff Writer | May 04, 2006 8:00 PM | 0 CommentsDenver, CO

  A new Canadian study shows that one-quarter of patients who suffered a heart attack while taking Vioxx did so within two weeks of taking their first prescription, much earlier than suggested by previous studies. The study was undertaken by McGill University Health Center in Canada, and involved analyzing the medical records of 239 elderly patients who had heart attacks while on Vioxx. "For...

• Ketek Safety Data Questioned

  Staff Writer | May 03, 2006 8:29 PM | 0 CommentsDenver, CO

  The Wall Street Journal recently investigated a clinical study involving 24,000 patients, referred to as 3014, which analyzed the safety of Ketek, a popular antibiotic sold by Sanofi-Aventis SA. Reports of severe liver damage, including death, have surfaced among patients taking Ketek, and the WSJ's investigation reveals serious flaws in the study, principally due to questionable practices by...

• Former FDA Commissioner under Investigation for Financial Ties to Drug Developers

  Staff Writer | May 02, 2006 8:25 PM | 0 CommentsDenver, CO

  FierceBiotech reports that former FDA commissioner Lester Crawford is under criminal investigation for possible financial ties to the drug developers he regulated at the FDA. The investigation is focusing on investments he or his wife had in companies that depended on the FDA for regulatory approvals. As John Carroll of FierceBiotech notes, "The FDA needs to set ethical standards, it needs to...

• Neutragard Anticavity Rinse Recalled

  Staff Writer | May 02, 2006 8:14 PM | 0 CommentsDenver, CO

  Pascal Company, Inc., the maker of NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse, has recalled all lots and flavors of its oral rinse due to possible contamination by Burkholderia cepacia (B. cepacia) and Pseudomonas aeruginosa bacteria. Although B. cepacia poses little medical risk to healthy people, individuals with weakened immune systems or...