Pharma Medical News about Botox Products

Your Article Summary

(Click the title below to leave the MDLinx Network and go to the Journal's Website)

FDA Warning. Agency Requiring Label Changes for Botox Products
American Family Physician, 05/11/09

The FDA is requiring safety label changes - including a boxed warning - and a risk evaluation and mitigation strategy for all botulinum toxin products. The agency said it took the action because of reports that the effects of the products may spread from an injection site to other parts of the body. This distant spread can cause symptoms such as muscle weakness, hoarseness or trouble talking, trouble speaking clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision, and drooping eyelids. The agency urged physicians who provide botulinum toxins to follow these steps:

understand that dosage strength expressed in units is different among the products, and clinical doses expressed in units are not interchangeable from one product to another;
be alert to and educate patients and caregivers about the potential for adverse effects;
understand that these effects have been reported as early as several hours and as late as several weeks after treatment; and
advise patients to seek immediate medical attention if they develop any of these symptoms.

<< Previous
HDM Wins 2 Journalism Awards

Next >>
Open Doorway to Truth: Legacy of the Minnesota Tobacco Trial

Proinflammatory cytokines synergistically enhance the production of chemokine ligand 20 (CCL20) from rheumatoid fibroblast-like synovial cells in vitro and serum CCL20 is reduced in vivo by biologic disease-modifying antirheumatic drugs
Journal of Rheumatology, 10/05/09 Relevance Score: 47%

Colloidal silver - science or fraud?
The Clinical Advisor, 11/09/09 Relevance Score: 46%

Covidien Introduces First FDA-Approved Spine Sealant
Covidien, 11/13/09 Relevance Score: 45%

Covidien Receives FDA Approval for Oral Transmucosal Fentanyl Citrate Product
Covidien, 11/05/09 Relevance Score: 45%

A brave new beef: The US food and drug administrations review of the safety of cloned animal products
Gender Medicine, 10/26/09 Relevance Score: 45%