A leading health advocacy group has called for a “black box” warning for Botox injections, saying the drug known best as a wrinkle reducer has been associated with the deaths of at least 16 people – and perhaps many more.
Public Citizen petitioned the government in January 2008 to force the makers of Botox and Myobloc, another botulinum toxin, to also send letters to patients and doctors warning about possible adverse effects including partial paralysis that can lead to trouble swallowing and possible aspiration pneumonia.
More recently, the U.S. Food and Drug Administration (FDA) announced that it would undertake a safety review of Botox and Myobloc after receiving reports of serious systemic reactions that led to hospitalizations and deaths.
An agency official said those reactions involved Botox injections in a variety of uses. Some of those uses were “off-label” – not the intended use for the drug, though not prohibited or necessarily inappropriate -- including injections to treat limb spasticity in children with cerebral palsy.
If you or a loved one suffered a serious injury or death as a possible result of using Botox or Myobloc, you may want to contact a Botox or Myobloc injury attorney.
Public Citizen cited 658 cases of adverse effects from 1997 through 2006, with 87 people requiring hospitalization and 16 fatalities. It noted that these were only cases voluntarily reported and estimated they accounted for only 10 percent of all actual cases.
The most serious incidents occurred when the drug was used not as a wrinkle remover but to treat ailments such as cervical dystonia, a painful knotting of neck muscles. Botox and Myobloc also are used to relieve shoulder muscle contractions and to treat crossed eyes, spasmodic eye blinking and excessive underarm sweating.
Included in the reported 16 deaths associated with the drugs, neurotoxins which block nerve impulses and relax muscles, four were people younger than 18. Only one fatality was associated with a cosmetic procedure.
During some treatments, Botox and Myobloc are administered close to the esophagus or can spread to other parts of the body and cause severe side effects. Among these is paralysis of respiratory muscles that can cause difficulty swallowing or cause food or liquids to enter the respiratory tract and lungs, causing aspiration.
In petitioning the FDA, Public Citizen said that with mandated warnings of potential side effects there would be an increased likelihood of earlier medical intervention when such problems occur. It said lives could be saved. (Read the petition)
Several other countries, including England and Germany, already require makers of the drugs to send letters to doctors warning of their possible dangers, while the drugs’ labels in Europe also bear a prominent warning on the hazards of the possible spread of the toxins. Early signs of Botox or Myobloc side effects are difficulty breathing or swallowing, and dry mouth.
Botox is manufactured by Allergan, Inc. Myobloc is made by Solstice Neurosciences.
Kline & Specter, PC, is a Philadelphia-based law firm with more than 40 attorneys, several of whom are also doctors. The firm is a leader in pharmaceutical litigation in Pennsylvania , New Jersey and nationwide. Click here to contact a Botox lawyer or a Myobloc lawyer today.