Posts Tagged ‘FDA’

FDA Approves Painkiller Overdose Field Treatment

April 14th, 2014

EIt’s no secret that misuse and abuse of opiate painkillers like OxyContin and Vicodin are a large and growing public health threat in Arizona-  misuse and abuse of these medicines are now killing more Arizonans than car crashes.

Last week the FDA approved a prescription treatment called Evzio that can be used in medical emergencies caused by prescription opiates or heroin.  It’s approved to approved to rapidly deliver a single dose of the drug naloxone using a hand-held auto-injector.  The goal is to put this in the hands of non-medical folks who might encounter overdose patients.  Our EMS agencies and hospitals have used naloxone for decades- but this new approval potentially opens administration opportunities to other first-responders as well.

There’s some concern in the medical community about using naloxone in the field because it can cause some pretty bad side effects in folks that have been using opiates for a long time…  but given the increase in deaths related to overdoses, the FDA has taken a pretty bold move.

Ocean Predators & Pregnancy

December 3rd, 2013

There was good news this week about preconception health.  A report just out from the EPA found that more women of childbearing age have been avoiding eating the kinds of ocean predators that typically contain mercury (Hg).  This is important because mercury can affect the baby’s brain being developed during pregnancy.  

Mercury is found in the environment, like the air and water, and turns into methyl mercury in fish- especially the fish at the top of the food chain (because the Hg bioaccumulates).  Methyl mercury is linked to many health problems especially for a developing fetus and nursing baby.   Because of this…  women who might become pregnant should avoid shark, swordfish, marlin, king mackerel, and tilefish (ocean predators).  They should also limit albacore or “white” tuna to only 6 ounces per week.  Fish that are low in mercury include shrimp, salmon, pollock & catfish. 

Women of childbearing age are realizing that their decisions today can help them have a healthier baby tomorrow.  We have some information about preconception health at our Women’s Health page or you can go to Womenshealth.gov. For more information about mercury while you are pregnant you can go to the March of Dimes or FDA websites.

Trans Fats on the Way Out?

November 18th, 2013

The FDA made a preliminary determination that partially hydrogenated oils (the primary dietary source of trans fat in processed foods) are not “generally recognized as safe” for use in food.  Their review of the research has led them to conclude that consuming trans fat raises LDL, or “bad” cholesterol, and increases the risk of coronary heart disease. The FDA opened a 60-day comment period this week.  Folks can submit electronic comments and scientific data and information until January 7.

Hydrocodone Combination Products Moving to Schedule II?

November 7th, 2013

Poisoning (including alcohol and prescription drugs) causes more deaths than car crashes in AZ.  Committed folks across the state are taking action on this issue.  We’re part of the Arizona Prescription Drug Misuse and Abuse Initiative, a multi-agency, multi-systemic approach to addressing the epidemic.  As part of this initiative, new guidelines have been issued for prescribing controlled substances in Emergency Departments and dispensing of controlled substances by pharmacists.  We are also one of four states that will be working with the Association of State and Territorial Health Officials over the next year to receive technical assistance to bolster our efforts to prevent and reduce prescription drug misuse in Arizona.  Now, a new tool may be on the horizon 

Last week the FDA announced that they’ll recommend to the US Department of health and Human Services that  hydrocodone combination products (like Vicodin) be reclassified from “Schedule III” to a the more restrictive “Schedule II” category.  The FDA will submit their formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II in December  They believe the National Institute on Drug Abuse will concur with their recommendation- which would begin a process that will lead to a final decision by the DEA on the scheduling change- which would better ensure that these products are properly prescribed and appropriately used by the patients who need them most.

Fungi in Medicine

October 9th, 2012

You’ve no doubt heard about the multi-state outbreak of fungal meningitis among patients who received an epidural steroid injections recently.  Here’s what we know right now:  Starting sometime in September some shipments of a steroid sometimes used to relieve back pain were contaminated with a fungus called Aspergillus fumigatus. Shortly thereafter patients in 23 states (not in Arizona at least so far) became ill with a form of fungal meningitis.  The only manufacturer that’s implicated in the outbreak is the New England Compounding Center.

The CDC, FDA, and all of the state (and some local) health departments are coordinating efforts to get to the bottom of the outbreak, identify who might be at risk, and providing information to clinicians to help them manage patients that may have been exposed but aren’t symptomatic yet.  The CDC has dedicated a special webpage about the investigation- including recommendations for clinicians and the public. Here’s the FDA’s list of recalled products (which includes more than the implicated product in case there were bigger problems at the plant.)

The contaminated product is called “preservative-free methylprednisolone acetate (80mg/ml)” and was prepared by the New England Compounding Center in Framingham, Mass. So far there have been over 100 cases and several deaths.  Initial symptoms seem to start 1 to 4 weeks after the injection and include fever, a worsening headache, nausea, and neurological deficit (like a stroke).  Fortunately, the records suggest that the steroid wasn’t shipped to Arizona- but we’re working with the county health departments to make sure that clinicians are on the lookout for symptoms in case the sales records aren’t correct.

STAND

September 19th, 2012

Our chronic disease prevention team and the county health departments, community partners, and Pima Prevention Partnership, officially launched STAND last week.  It’s a coalition of local youth groups that have banded together in a common cause against tobacco use.  It’s the culmination of a three-year effort to engage more youth in the actual planning and implementation of tobacco control.  Through adult and youth trainings, an annual celebratory conference, and an increased online presence via STAND Facebook and www.Standaz.com, local coalitions retain their identities while maximizing their impact on a statewide basis. 

Trainings for adult coalition leaders, as well as youth coalition members, have been held regionally during both the fall and spring in Phoenix, Flagstaff and Tucson.  Adult coalition leaders learn how to effectively foster youth coalition development, assist the coalition members where needed and provide additional logistical support. Individual technical assistance is provided where needed to both youth and adults.  Trainings for the youth include education on advocacy, public speaking, social media and message development. A winter summit is in the works that will bring together youth to start planning for the end of the year youth tobacco coalition conference. 

Building on the momentum and outcomes of the highly-successful Venomocity campaign, this represents an expansion of our youth prevention efforts that now includes youth coalition activities, prevention outreach, point-of-sale efforts including the Attorney General’s sting operations, and the FDA program.  As the centralized hub of activity STAND will provide information and resources for youth and adult leaders.  Facebook and YouTube sites have also been created to tap into the social media opportunity that presents itself when working with youth. 

While overall use of tobacco among Arizona youth has mirrored the national trend of leveling off, Arizona has seen the single largest decrease in overall consumption (measured by teens who report smoking more than ten cigarettes per day).  This new launch of intensifying youth-to-youth involvement is the result of our robust formative research in figuring out the how’s and why’s of successful interventions.

Political Convention Food Tested by Our Lab

September 11th, 2012

Our State Lab performed chemical and biological surveillance testing on food samples from the Republican National Convention.  We were selected to participate in the testing because of our reputation and previous experience working with the Food Safety Inspection Service for the detection of biological and chemical agents in food.  The samples arrived at the State Laboratory the week of August 20 and were tested the same week.  Our lab performs this work as part of the national Food Emergency Response Network using funds from cooperative agreements obtained USDA and FDA.  Everything was OK.

Breastfeeding & Cannabis

September 4th, 2012

Some AZ health care providers and parents have asked questions about whether medical marijuana is safe for use while breastfeeding.  The short answer is no, because the active chemical in marijuana is passed to the baby through breast milk. For this reason, most experts, including the American Academy of Pediatrics and the CDC advise moms not to use marijuana (medical or not) while breastfeeding.   

Tetrahydrocannabinol (the psychoactive ingredient in Cannabis) stays in the body for four to six weeks.  It’s found in the urine of breastfeeding babies whose mothers use marijuana. It’s also fat soluble, which means it builds up with chronic use and can be stored in fat tissue for months. We also know that babies are much more vulnerable than adults to illness, infection, chemicals, and so on. That alone is a good reason to avoid marijuana and anything else potentially harmful that can enter your baby’s body through your milk.  

The Academy of Breastfeeding Medicine has a protocol that you can use to make breastfeeding decisions.  For more information about the effects of marijuana and other medications, go to the National Libraries of Medicine’s LactMed database. For answers to this and other breastfeeding questions, call the ADHS 24-hour breastfeeding hotline at 1-800-833-4642. 

Of course- all sorts of prescription and over-the-counter medicines are also transferred to infants in breast milk- but pediatricians are more familiar with which medicines are safe to take while breastfeeding because they’re tested by the FDA- and most medicine labels discuss breastfeeding.

Arizona’s Food Safety Network

October 11th, 2011

The Listeria monocytogenes outbreak has captured the public’s attention these days- so I thought I’d do a piece on Arizona’s food safety network. Let’s start at the farm & ranch.  The Arizona Department of Agriculture is responsible for ensuring that the base of the food safety pyramid is solid in Arizona.  They have several divisions that are responsible for everything from Arizona farm-grown fruits and vegetables to livestock and poultry.  They also work with the USDA & the FDA to ensure that imported foods are safe and from an approved source.  So, basically, the AZ Dept. of Agriculture is responsible for food safety from the farm or ranch until the food hits the wholesaler or “jobber’s” warehouse. 

Once foods hit the middleman- it’s our job to ensure that food is safely handled until it makes it to your plate at a restaurant or leaves the grocery store in your cart. While our environmental health shop has the overall responsibility for ensuring that your food is safe from the warehouse to you- it’s our partnerships with the local health departments and departments of environmental services that make the system work.  We use the framework outlined in state law and our food safety rules to help guide the counties to make effective decisions in the field.  You can see a more detailed summary of the statewide activities in our latest annual food safety report (the new report is due out in a month or so). 

We delegate our food safety authority to the local health departments who use our authority do the actual inspections for restaurants and food retailers.  But, some of the counties actually act on their own- using authority granted from their board of supervisors.  For example, Maricopa County Environmental Services acts under their county authority rather than using our statewide authority.  All the inspections are done by people called Registered Sanitarians, who are required to have at least 30 hours of college credits in the natural sciences and pass a registration test

Of course, no food safety network would be complete without a robust foodborne illness surveillance system including the laboratory capacity to identify and track foodborne illnesses.  This part of the network also includes collaboration with the local health departments.  Physicians and private labs that identify or diagnose foodborne illness infections report that info to their local health department.  By pulling together the statewide data- we’re able to identify trends and sources- and along with the CDC’s resources, the public health system provides the feedback loop to the food safety network- allowing the system to track down and stop sources.

Flu Down Under

August 4th, 2011

This is the time of year that public health folks start watching the flu reports from the southern hemisphere.  We’re watching for a couple of things – the circulating strains and how it’s spreading.  The Australian Government Department of Health is reporting 6 times as many cases as they had at this time last season.  It could be an early season for them or it could be that it will end up being a blockbuster flu season for them.  The good news is that the circulating strains are all covered by the vaccine strains approved by the FDA last week –meaning that there aren’t any surprise strains going around (at least so far).  The H1N1 pandemic strain is dominant in Australia right now.