Posted by: Salvatore J. Zambri, founding member and senior trial attorney.
According to a recent alert issued by the
U.S. Food and Drug Administration (FDA), health care professionals are being cautioned as a result of recent serious
eye infections resulting from
Avastin injections. Several recent incidents of patients losing all remaining
vision after Avastin injections prompted the FDA alert. Although Avastin
is approved for treatment of some cancers, it has not been approved, but
is frequently-prescribed treatment for wet age-related macular degeneration
(AMD). Regulators and manufacturers warn against unapproved use of Avastin,
citing infection and loss of vision as examples of the risks associated
with doing so. It is believed that the tainted injections were from a
pharmacy that repackaged the preservative-free vials into smaller single-use
syringes. The investigation continues.
The FDA alert states: "Health care professionals should be aware that
repacking sterile drugs without proper aseptic technique can compromise
product sterility, potentially putting the patient at risk for microbial
infections. Healthcare professionals should ensure that drug products
are obtained from appropriate, reliable sources and properly administered.
Avastin solution for intravenous infusion is approved for the treatment
of various types of cancers. Some physicians also prescribe Avastin off-label
for the treatment of wet age-related macular degeneration, although Avastin
is not currently approved for this indication."
Genentech, the division of Roche that manufactures Avastin, maintains that
caution against unapproved use was always advised. According to a Genentech
spokesman, "Avastin is not manufactured or approved and to date has
not been proven safe for use in the eye." Many ophthalmologists argue
that Avastin is a much cheaper alternative treatment of wet AMD and that
the infection and vision-loss incidents are due to carelessness instead.
The safety debate regarding off-label use continues.
Please check with your doctor if you have been prescribed any off-label
medications. Although some off-label prescribing of medication has existed
for an extended period of time, the fact that serious infections and even
blindness can occur when a cancer medication to treat eye disease reveals
that it is a risky practice.
Do you have questions about this post?
About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial
Lawyers Association of Metropolitan Washington, D.C. The association has
recently named him the
" 2011 Trial Lawyer of the Year". He has also been acknowledged by Washingtonian magazine as a "Big
Gun" and among the "top 1%" of all of the more than 80,000
lawyers in the Washington metropolitan area. The magazine also acknowledged
him as "one of Washington’s best–most honest and effective
lawyers" who specializes in medical malpractice matters, product
liability claims, and serious automobile accident claims. Mr. Zambri was
recently (2011 edition) acknowledged as one of the
"Best Lawyers in America" by
Best Lawyers, and has also been repeatedly named a
"Super Lawyer" by
Law and Politics magazine (2011)–a national publication that honors the top lawyers
in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors,
as well as both medical and law students concerning defective drugs, medication
errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at
firstname.lastname@example.org. You may also reach him at 202-822-1899.