4 More States Broaden Access to Boosters for Adults, Ahead of F.D.A. Public Health Warning – NBC Bay Area / Richmond, VA http://www.nbcbayarea.com/news/the-health-recall/ns-66052076.html?utm_medium=social&utm_campaign=SocialSecurityNews&utm_source=blog&utm_content=nb_blog_blog.
On Monday’s broadcast of the Today Show, the Food and Drug Administration (FDA) issued a public health warning to anyone who has taken a consumer supplement containing the autism booster, DDPY(buprenorphine or naloxone). The FDA is warning of serious and potentially life-threatening side effects and deaths associated with use of these supplements by adults with opioid abuse disorder and/or a history of drug dependence. The FDA took the action after receiving reports of 40 deaths associated with the supplements in the past 10 years.
The FDA said it is issuing its warning after a review of reports filed with the Substance Abuse and Mental Health Services Administration (SAMHSA) for possible side effects, including death, attributed to the products. SAMHSA provides incentives to states that set up monitoring programs for opioid use disorders to allow the reporting of adverse events to the prescription drug monitoring programs (PDMPs). According to the FDA, the currently available information indicates the use of supplements containing naloxone to treat opioid use disorder (UUD) and/or to block withdrawal symptoms of heroin does not appear to be working as intended to help people stop using opioids. When used by adults with opioid use disorder, the supplements cause memory and balance problems, problems swallowing, shortness of breath, mouth ulcers, poor urination, and dizziness and can lead to inadvertent overdoses from any source, including opioid abuse or dependence, the FDA said.
“Consumers need to know there are serious side effects associated with these products,” said Ross Mandell, director of FDA’s Division of Consumer and Market Access. “It’s possible that they could inadvertently overdose or pose a great danger to themselves and others.”
FDA has received reports from 29 states that supplement manufacturers are marketing and marketing the products even though they are not registered with the FDA and do not require a public safety review by the agency. DDPY(buprenorphine or naloxone) was approved by the FDA in January 2017 and is being advertised as being a safer alternative to either buprenorphine or methadone to treat opioid use disorder. However, since January 2017, the FDA has received reports of 19 deaths and two cases of accidental overdose of children under the age of 6. Due to insufficient testing, the supplement has not been approved to treat opioid use disorder in children.
Consumers should avoid using the supplements, and if they already use the products, it is recommended that they stop using them. Supplement providers, pharmacies, doctors and health care professionals should also inform their patients of the risks associated with using these products. Those who are using these products should follow safe handling and use instructions.
Products that contain naloxone are sold across the country in various formulations including pre-mixed powder pills, tinctures, topical salves, nasal sprays, nasal strips, herbal extracts, crushed pills, liquids, personal medication disposal kits, capsules, and “Jointwear” patches.
Anyone who has received a product via a mail or online order order from DDPY(buprenorphine or naloxone) or a distributor and plans to purchase, use, or administer the product are advised to call the FDA’s MedWatch Adverse Event Reporting program at 1-800-FDA-1088 (1-800-332-1088 if you are deaf or hard of hearing) or the abuse reporting hotline at 1-800-831-5464 to report any adverse reactions to the product. Additionally, if a distributor or consumer sells a product using a gram-fed stamp, consumer should obtain a C-38 form, found online at FDA’s website. All forms must be filed electronically with the agency.
For more information about FDA’s approach to drug abuse, visit: https://www.fda.gov/prescriptiondrugs/abuse-prevention/ucm37165.htm.