Posts Tagged ‘FDA’

Are E-cigarettes an Important Tool in the Tobacco Fight?

May 21st, 2014

E-CigThere’s no substitute for evidence when it comes to public health decision-making.  Over the last couple of years the public health community has been asking itself whether electronic cigarettes can play an important role in getting folks to kick their tobacco habit.  We haven’t had much evidence to answer that question so far… but a study published today in the Journal Addiction suggests that e-cigarettes may be a very effective cessation tool (if used properly).

The study basically examined the success rate for quitting tobacco among people that used e-cigarettes as a smoking cessation tool and compared their success rate with people that used classic over the counter nicotine replacement therapy and people that tried to quit cold-turkey.   They found that people that used e-cigarettes to quit their tobacco habit were more likely to be successful than people that used over-the-counter nicotine replacement tools (e.g. lozenges, gum etc.) or that tried to quit cold-turkey.

In epidemiological-speak- the study found that: “The adjusted odds of non-smoking in users of e-cigarettes were 1.63 (95% confidence interval 1.17 to 2.27) times higher compared with users of NRT bought over-the-counter and 1.61 (95% confidence interval 1.19 to 2.18) times higher compared with those using no aid.”

Of course, this doesn’t close the book when it comes to whether e-cigarettes do more harm than good when you consider that some of the e-cigarette companies appear to be marketing to non-smokers and kids- but it’s probably the most important piece of evidence that we have so far when it comes to determining whether e-cigarettes are an important cessation tool if managed properly.

P.S.:  The FDA’s proposed new regulations for e-cigarettes are still out for public comment.  Here’s a link to a  previous blog post on that subject.

FDA Study Committee Recommends Disapproval of New Opiate Painkiller

April 29th, 2014

prescriptionLast week an FDA panel unanimously recommended rejecting a new drug that’s a combination of morphine and oxycodone – two very strong painkillers.  The panel, Anesthetic and Analgesic Drug Products Advisory Committee, said the company didn’t provide data to prove that Moxduo is more effective or safer than using one of the already available drugs.

 

FDA Bites the E-cigarette Regulation Bullet

April 24th, 2014

E-CigIt’s no public health secret that tobacco use continues to be a dominant cause of preventable disease and death in the US.  While the trend has been encouraging (Arizona’s smoking rate is down to 17%), there’s still much work to be done- and continued efforts to provide creative and effective ways to help adult smokers kick the habit are a key public health intervention strategy.

The flurry of electronic cigarettes that have come on the market recently have thrown us a tobacco cessation curve ball.  Over the last couple of years the public health community has been asking itself “… do the risks of electronic cigarettes outweigh their potential benefit as a smoking cessation tool?”.   The answer to that question depends on whether and how electronic cigarettes are regulated by the FDA.  Today, we got some information to help answer this key question.

Today the FDA released proposed new regulations that (when finalized) would: 1) ban selling of e-cigarettes to minors (it’s already illegal in AZ); 2) prohibit the distribution of free samples to anyone; 3) ban selling e-cigarettes in vending machines unless they’re in places where kids can’t come; 4) require e-cigarettes to have labels stating that they contain addictive nicotine; 5) require e-cigarette manufacturers to disclose the ingredients in their products; 6) require current e-cigarettes to provide  justification for remaining on the market…  and require new e-cigarettes to get FDA approval before being sold; and 7) only let e-cigarette claim that their product reduces risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health.

The  proposed new regulations wouldn’t restrict or ban the sale of fruit and chocolate flavored e-cigarettes that some believe are designed to attract and hook young people.  They also wouldn’t restrict TV advertising or online sales.

The FDA will begin accepting public comment on the proposed new regulations tomorrow.

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.