FDA issues adverse reaction warning about Botox
WASHINGTON The Food and Drug Administration has notified the public that Botox, Botox Cosmetic and Myobloc (botulinum toxin type b) have been linked to adverse reactions in patients including respiratory failure and death.
The agency has stated that early indications, based on review of materials, links the reactions to overdosing of the medications and not defects in the products.
The adverse effects were found in FDA-approved and nonapproved products. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of Botox products in children or adults.
The adverse reactions appear to be related to the spread of the drug to areas distant from the site of injection, and copy symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.
The FDA is not advising health care professionals to discontinue prescribing these—Allergan and Solstice Neurosciences—products and stated that it is currently reviewing safety information from clinical studies performed by the manufacturers of the drugs.
HealthPort receives SureScripts’ certified approval
COLUMBIA, S.C. HealthPort’s Electronic Medical Record application is now certified to connect to The Pharmacy Health Information Exchange operated by SureScripts.
HealthPort’s e-prescribing module replaces old error-prone approaches to prescribing such as handwritten prescriptions, computer-printed prescriptions, and computer-faxed prescriptions. It also reduces the risk of medication errors associated with poor handwriting, illegible faxes, similar sounding/named drugs, and manual data entry.
As a SureScripts Certified Solution Provider, HealthPort’s physician clients who use its electronic medical record product can now connect to the Pharmacy Health Information Exchange, operated by SureScripts. The Pharmacy Health Information Exchange allows physicians and pharmacists to electronically exchange prescription information and electronically transmit new prescriptions and refill requests during routine and emergency care.
Today, more than 95 percent of all pharmacies are certified on the Pharmacy Health Information Exchange and approximately two-thirds are processing prescriptions electronically.
FDA is not ready to pursue authority to approve follow-on biologics
WASHINGTON Food and Drug Administration spokesperson Christopher Kelly recently said that, despite comments from an agency official on Monday, the agency will not submit to Congress a legislative proposal to seek authority to approve generic versions of biotechnology medications, CongressDaily reports.
FDA chief operating officer John Dyer had said on Monday that the agency had begun to draft language for such a proposal. In addition, a congressional aide said that the FDA informed the House Energy and Commerce Committee about plans to submit such a proposal but did not disclose a timeline.
Kelly said that the comments from Dyer resulted from a misunderstanding. Fiscal year 2009 budget documents refer to a legislative proposal that will provide recommendations on an FDA approval process for generic versions of biotech medications. Kelly said that the reference to such a proposal was an “expression by FDA of our interest in moving this forward, not an actual proposal.”