Guest guest Posted January 8, 2009 Report Share Posted January 8, 2009 A couple months ago I inquired about taking part in a phase 3 clinical trial for the oral MS drug laquinimod. I finally heard back from the study today. It's a two-year double blind study in which one may be assigned laquinimod, placebo or Avonex. I "passed" my initial phone screening this morning. The next step is an in-person meeting in Sacramento. It's too early to know if I'll actually be in the study. And, if I do, I have to stop taking Copaxone for two months before starting in the trial. In any case, I hope we can finally get an oral treatment for RRMS!Dan U dao_nguu@...To: MSersLife From: reikilady@...Date: Thu, 8 Jan 2009 09:54:56 -0600Subject: Fw: FDA MedWatch - January/February 2009 FDA Patient Safety News is now available... FDA MedWatch - January/February 2009 FDA Patient Safety News is now available... FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch e-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions. Stories in the January/February 2009 edition include: Serious Infections and Neurological Events with Raptiva (efalizumab) New boxed warning to highlight the risk of bacterial sepsis, viral meningitis, PML and other opportunistic infections… Recall of ReliOn Syringes In the one recalled lot sold by Wal-Mart and Sam’s Club, some U-40 insulin syringes mistakenly labeled as U-100 insulin syringes… Ethex Corp. Recalls Several Generic Drugs Oversized tablets may contain up to twice the labeled amount of active ingredient… Serious Complications with Surgical Mesh for Gynecologic Surgery Healthcare professionals should be vigilant for adverse events such as erosion and infection… More Mix-ups between Propylthiouracil and Purinethol (mercaptopurine) ISMP’s recommendations to help prevent dangerous mix-ups with between the two drugs… Drug Name Confusion between Kuric (ketoconazole) and Carac (fluorouracil) Helping to prevent mix-ups between these two topical creams with “sound-alike†names… New Labels for Non-prescription Cough and Cold Medications Most makers of these products are changing the labels to say “do not use†for children under 4… You are encouraged to report all serious adverse events and product quality problems for human medical products to MedWatch at: www.fda.gov/medwatch/report.htm. Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact supportgovdelivery. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · Windows Live™ Hotmail®: Chat. Store. Share. Do more with mail. See how it works. Quote Link to comment Share on other sites More sharing options...
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