Events

Safety Alert for WariActiv Vapo Coolant Anesthesia Aerosol Spray, Ethyl Chloride

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2017-086
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/420134-fda-advisory-no-2017-086-public-health-warning-against-misuse-of-wariactiv-vapo-coolant-anesthesia-aerosol-spray-ethyl-chloride
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2017-086 public health warning against misuse of wariactiv® vapo coolant anesthesia aerosol spray, ethyl chloride the food and drug administration (fda) advises the public against the misuse of wariactiv® vapo coolant anesthesia aerosol spray, ethyl chloride (please see picture below). the said product is a registered medical device and was approved as local skin anesthesia. however, the fda received reports that the product is being indiscriminately used by some individuals. the product is being misused by inhaling it to feel “high” or happy. the abuse and misuse of the product’s active ingredient, ethyl chloride, could lead to the following adverse effects: acute (short-term) inhalation exposure to high levels of ethyl chloride in humans has resulted in temporary feelings of drunkenness, dizziness, lack of muscle coordination and unconsciousness.* chronic (long-term) effects include ataxia (uncoordinated movements), tremors, speech difficulties, slowed reflexes, involuntary eye movement, and hallucinations, and liver effects were reported in individuals who purposely inhaled very high concentrations of ethyl chloride for a few months.* sudden sniffing death syndrome**                                                               in the interest of protecting public health and safety from adverse health effects brought about by the abuse and misuse of the product, the public is hereby advised to use the product only in accordance with its approved use. likewise, advertisement of the product in all forms of media other than its approved use is prohibited. retailers are also advised to avoid indiscriminate selling of the product to customers. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. references: 1. united states environmental protection agency website*                          (https://www.Epa.Gov/sites/production/files/2016-09/documents/ethyl-chloride.Pdf)                   2. dr. lynn crisanta r. panganiban, professor, department of pharmacology & toxicology, up college of medicine/consultant, national poison management & control center, up college of medicine – philippine general hospital** attachments: fda advisory no. 2017-086.Pdf.

Device

WariActiv Vapo Coolant Anesthesia Aerosol Spray, Ethyl Chloride
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP