US Pharm.
2006;11:78.
Gleevec Tablets Associated
with Cardiac Events
Novartis and FDA
announced revisions to the Precautions section of the prescribing information
for Gleevec (imatinib mesylate) that details the occasional occurrence of
severe congestive heart failure and left ventricular dysfunction in patients
taking Gleevec. FDA recommended that patients with heart disease or risk
factors for heart failure be monitored carefully and that any patients with
signs or symptoms consistent with heart failure be evaluated and treated.
Guidance Issued on
Cell-Based Viral Vaccines
FDA has issued new
guidance to aid manufacturers in the development of safe and effective
cell-based viral vaccines. The guidance provides manufacturers with updated
recommendations to the 1993 document "Points to Consider in the
Characterization of Cell Lines Used to Produce Biologics." It also provides
information on determining the suitability of a cell culture for manufacturing
and testing and validating the safety and purity of the cells used in the
development and production of vaccines. A copy of the guidance is available at
www.fda.gov/cder/gdlns/vaccsubstrates.pdf.
Updated Alert on
Meningococcal Conjugate Vaccine
FDA and CDC have
updated an October 2005 alert regarding reports of Guillain-Barré syndrome
following administration of meningococcal conjugate vaccines A, C, Y, or W135
(Menactra). To date, a total of 15 confirmed cases of Guillain-Barré syndrome
occurring within six weeks of vaccination with Menactra have been reported in
individuals ages 11 to 19. An additional two cases have been reported in
adults 20 and older.
Office of Generic Drugs Adopts
New File System
FDA's Office of
Generic Drugs has begun using the Division File System (DFS), a new
information technology system for reviewing and archiving ANDAs
electronically. The DFS improves the efficiency of the generic review process
by enabling better tracking and search capabilities of archived ANDA documents
and allowing the Office of Generic Drugs and the Office of New Drugs--which
have been using the DFS since 2000--to have full access to reviews completed in
either office.
FDA Issues Final Quality
Systems Guidance
Final guidance on
quality systems has been issued by the FDA to help ensure the manufacturing
quality of human and veterinary drugs and biological drug products. The
guidance contained in the document "Quality Systems Approaches to
Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations"
demonstrates the benefits of incorporating modern quality principles to better
ensure the safety and efficacy of drugs, which should help lower costs and
prevent shortages of medicines due to manufacturing failures. A copy of the
guidance is available at www.fda.gov/cder/guidance/7260fnl.htm.
CoaguChek PT Test Strips
Recalled
Roche Diagnostics
and FDA have announced the recall of CoaguChek PT test strips, which are used
to determine blood-clotting time of patients taking anticoagulant medication.
FDA advised health care professionals who use CoaguChek PT test strips to
institute "duplicate testing" or to use two strips with different lot numbers
for each patient to reduce the risk of bias. It advised home users of the test
strips to immediately discontinue use of the product and contact a health care
provider.
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