When I was growing up on apple ranches in Central Washington, the word botulism was scary.
We often canned fruits, water-packed in glass jars, but not vegetables. Our gardens abundantly grew green beans, but we seldom canned them. Green beans and other vegetables don’t have acid, and they’re more likely to develop Clostridium botulinum, a severe type of food poisoning.
Occasionally, we’d hear about people dying from botulism.
So how did this bacterium that is so poisonous become the most common cosmetic procedure with the cute name, Botox, that 4.6 million people in the United States chose to have in 2007?
The U.S. Food and Drug Administration first approved Botox in 1989 to treat two eye muscle disorders – uncontrollable blinking and misaligned eyes. In 2000, the toxin was approved to treat a neurological movement disorder that causes severe neck and shoulder contractions.
As an unusual side effect of the eye disorder treatment, doctors observed that Botox softened the vertical frown lines between the eyebrows that tend to make people look tired, angry, or displeased. But until this improvement was actually demonstrated in clinical studies, Allergan Inc., of Irvine, Calif., was prohibited from making this claim for the product.
By April 2002, the FDA was satisfied by its review of studies indicating that Botox reduced the severity of frown lines for up to 120 days. The agency then granted approval to use the drug for this condition.
FDA notifies public about adverse Botox reactions, deaths
On Feb. 8, 2008, FDA notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.
The agency said in a news release the reactions may be related to overdosing. “There is no evidence that these reactions are related to any defect in the products,” the public notice said.
The adverse effects were found in FDA-approved and nonapproved usages. 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 botulism toxins in children or adults.
The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness, and breathing problems.
“The FDA is not advising health care professionals to discontinue prescribing these products,” the public notice indicated.
The agency is reviewing safety data from clinical studies submitted by the drugs' manufacturers, as well as post-marketing adverse event reports and medical literature. After completing the review, the FDA said in its public notice that it will tell the public about its conclusions, recommendations, and any regulatory actions.
For details, see “Early Communication About an Ongoing Safety Review Botox and Botox Cosmetic (Botulinum Toxin Type A) and Myobloc (Botulinum Toxin Type B).”
Public Citizen thinks FDA’s Botox warning falls short
Public Citizen, a citizen’s organization, thinks FDA should do much more than send out a press release about its concerns because Botox and Myoboloc have been linked to adverse reactions, including respiratory failure and death.
Two weeks before the FDA issued its announcement, Public Citizen petitioned the FDA to immediately increase its warnings about the serious risks of using Botox and Myoboloc.
“Adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing, a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia,” said Public Citizen in a news release. “Our analysis of FDA data found that the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections, including 16 deaths.
“Every doctor who is injecting botulinum toxin needs to know about the dangers of the toxin spreading to other parts of the body,” Public Citizen said. “The only way this is going to happen is by requiring the makers of the drug to send warning letters to all doctors who use Botox and Myoboloc.”
Every patient needs to know about these risks, the group believes. “The only way this is going to happen is if doctors are required to hand patients a written warning every time they receive an injection.”
It’s not enough that the FDA publicly acknowledges the risks of using botulinum toxin, said Public Citizen, adding, the agency did this in a published article three years ago. “The FDA must immediately force the drug makers to send out warning letters to doctors, similar to what drug regulatory agencies in Europe already require.”
The FDA also should label the products with a “black box” warning, the strongest warning the agency can make and require doctors to hand out medication guides to patients, warning them of the early symptoms of an adverse reaction, the group said.
“The FDA needs to move quickly to educate physicians and patients,” according to Public Citizen. “Nobody should be dying from injected botulinum toxin.”
Possible reactions to Botox
The side effects of Botox, according to the FDA, may include:
- Droopy eyelids, which can last for a few weeks.
- Feeling like you have the flu.
- Headache and upset stomach.
- Risk of botulism (a life or death illness that makes it hard for a person to move the arms and legs or to breathe). The risk of botulism is low with Botox, if it is used the right way.
What boomer consumers should know
If you choose to have Botox injections, be an informed consumer. Be aware that the American Academy of Dermatology warns consumers that a casual social setting like a Botox party is an inappropriate and a potentially dangerous setting for performing medical procedures of any kind.
Here are resources to help you in your research:
“Risks of Erasing Wrinkles: Buyer Beware!” – American Academy of Neurology
“Botox™” – Food and Drug Administration
“Botox” – MedlinePlus
“Is Botox Bad For You?” – WIFR.COM
“Botox Rat Study Shows Toxins Migrate to the Brain” – Cosmetics design-europe.com
“Botox: Is This Wrinkle Treatment for You?” – MayoClinic.com
“Bad Botox Shot Contained Raw Botulism” – Natural News
"U. of Calif. Study: Botox Spreads into Neighboring Tissue” – LawyersandSettlements.com
“FDA Warns of Children’s Deaths Linked to Botox” – Bio-Medicine
FDA Issues Botox Warning” – consumeraffairs.com
“FDA Reviewing Safety of Botox” – ConsumerReports.org
"Botox Feels Like You've Had a Stroke" – LawyersandSettlements.com
Why You Should Think Twice Before Having Plastic Surgery will be the next topic on The Survive and Thrive Boomer Guide.