Injectable Safety News & Consumer Alerts

Clarity for Consumers On Botox Complication and Death Reports

January 25, 2008. The Physicians Coalition for Injectable Safety offers consumers clarity on the safety of Botox® injections for cosmetic indications following reports that Public Citizen has requested the FDA require a stronger black box warning for the drug. Consumer should not be alarmed by the request of Public Citizen, but must put this report into perspective:

Botox® has 6 FDA label approvals including cosmetic indications to treat facial expression lines caused by the contraction of facial muscles. Clinical applications of Botox® to treat serious neuromuscular disorders such as cervical dystonia and cerebral palsy are the source of data for the petition request to the FDA for Black Box warnings.
The brands Botox® and Myobloc® used for the treatment of medical disorders are the subject of the petition. The Botox® Cosmetic brand is specifically labeled and approved for cosmetic indications. Myobloc® is not approved for cosmetic indications.
The Public Citizen report is focused on cases where botulinum (Botox® or Myobloc®) was injected to treat very serious neuromuscular disorders and serious medical illness. The reported 180 cases of serious complications and reported 16 deaths are collected from 9 full years of data. Comparatively, it is estimated that nearly 17 million Botox® injections have been safely administered for cosmetic purposes alone (Botox® Cosmetic received FDA approval for cosmetic indications in April, 2002).
The dosing of Botox® to treat the medical disorders cited in the Public Citizen report is often ten-fold the number of intramuscular units (i.u.'s) injected to treat the cosmetic patient. In perspective, a typical dose to treat the glabella, or furrows between the brows consists of 20 to 35 i.u.'s (intramuscular units), whereas a patient treated for a neuromuscular disorder may receive 200 or more units.
The Black Box warning petitioned to the FDA by Public Citizen emphasizes the Coalition's position that consumers should always see the packaging of cosmetic injectables to verify brand authenticity.
The Coalition offers consumers these prevailing cautions: Choose a physician carefully, question the authenticity of the injectable, and pay close attention to the potential complications which should always be thoroughly defined by the doctor during the informed consent process.
Consumers who have questions about the safety of Botox® for cosmetic indications should discuss their concerns with a properly trained and qualified physician who regularly treats patients' cosmetic concerns with Botox®. Download this alert [PDF]

Coalition Responds to Consumer Concerns on Lipodissolve

December 12, 2007. The Physicians Coalition for Injectable Safety today issued an advisory for consumers with questions or concerns about fat dissolving, fat melting, injection lipolysis or other injectable treatments touted to reduce localized body fat. The proliferation of advertising of such treatments and the abrupt closing of Fig lipodissolve centers nationwide has evoked many questions from both patients considering treatment, and those who have already been injected with the unproven medical treatments touted to reduce localized fat. To date, injection lipolysis, lipodissolve or any fat-melting injection has not gone through FDA sanctioned clinical trials or the research necessary to document the results claimed, or to clearly identify the potential underlying complications.

Consumers with questions, or who have endured complications from any of these injections should seek out the advice of a board-certified plastic surgeon specializing in accepted aesthetic procedures such as liposuction. Anyone experiencing serious complications that affect personal health should immediately seek out the advice of a qualified medical doctor.
There is presently no valid research on fat-melting injections that demonstrate reproducible, safe outcomes. There is much more unknown and unproven about these injections than there is proven.
Injection lipolysis by any name, is not a beauty treatment. This is a medical treatment that involves hundreds of injections into the body of a compounded mixture of drugs. This mixture is not FDA approved nor has it been formally tested for predictable results or safety . Download this alert [PDF]

Recent “Pumping Party” Bust A Safety Reminder
July 2008

Can Nurses Inject Botox?
May 2008

Botox and Restylane Not A Destination or Spa Treatment
May 2008

Consumers are naive to the risks of Botox parties [PDF]
May 2008

Physicians Coalition Partner to FDA Counterfeit Alert Network
April 2008

Cosmetic Injectables No Contest or Party
March 2008

Clarity for Consumers On Botox Complication and Death Reports
February 2008

Holiday Self-Improvement Trends
December 2007

Consumer Safety Alert on Fat Dissolving Injections
October 2007

Consumer Safety Alert on Cosmetic Injectable Complications
October 2007

Patients Seeking Injectables Should Weigh Training and Qualifications Over Convenience
September 2007

Physicians Coalition For Injectable Safety Responds To Kansas Actions On Lipodissolve
September 2007