Will using expired drugs kill you?

Earlier this month, Cecil at StraightDope.com addressed the question, "Will using expired drugs kill you?" The answer was mostly no.

We have to tread carefully here, ... A few drugs don’t age well — for example, nitroglycerin and insulin. But they’re the exception. Most drugs retain their potency for years after they supposedly expire.

In 1978 the FDA started requiring drug companies to place expiration dates on drugs. But no testing was done. Many picked a one year expiration in the hopes that you would throw away old medicine and buy it again.

No everyone liked this. The Pentagon had $1 billion of stockpiled drugs that it didn’t feel like throwing out so it asked for FDA testing in the mid-80's in a program called Shelf Life Extension. The results?

* one year AFTER expiration, every drug tested was still OK
* 88 percent of the drugs were safe and effective five years after expired

Bottom Line

The Consumer Reports recommends throwing out any drug more than a year past its expiration date. So expiration plus one year with a few exceptions:

* epinephrine, used to treat cardiac arrest, steadily loses its potency over time
* Liquid drugs and suspensions are less stable than solids
* Medications custom-made by your local pharmacy are likely to have a short shelf life
* nitroglycerin
* insulin

If you have not used up a medicine before one year past expiration, did you really need it?

P.S. Please don't dump old medicine in a toilet. Did you know that some public drinking water tests positive for common medications?

Drug Shortages

"The global market is starting to show cracks; the world is definitely not a flat billiard table. It's looking more and more like an out-of-balance roulette wheel."
-Edward Tenner, The Atlantic.com

I've seen a lot of buzz lately regarding a Washington Post story about a Shortage of Key Drugs.

A record 211 medications became scarce in 2010 — triple the number in 2006 — and at least 89 new shortages have been recorded through the end of March, putting the nation on track for far more scarcities. The paucities are forcing some medical centers to ration drugs — including one urgently needed by leukemia patients — postpone surgeries and other care, and scramble for substitutes, often resorting to alternatives that may be less effective, have more side effects and boost the risk for overdoses and other sometimes-fatal errors.

The article identifies three factors for the increasing scarcity:

1. Major pharmaceutical companies purchased smaller companies with patents on life-saving drugs. But when the patents expired, the big company abandons production because it will now be less profitable.

2. The pharmaceuticals claim there is tougher regulation of production by the FDA (which the agency denies).

"Shortages of pre-loaded epinephrine syringes and propofol, for example, occurred when suppliers dropped out just as the FDA was demanding additional documentation."

3. Globalization of manufacturing means a storm or natural disaster anywhere in the world can stop production of an item with many components. Globalization also raises concerns about the quality of the ingredients used.

The drug cytarabine has caused the most concern and gotten the most attention because it is highly effective for treating several forms of leukemia and lymphoma. [...] Many hospitals are running low, and some have run out completely. [...] Cytarabine’s scarcity was caused by hitches that two out of the three manufacturers hit in obtaining raw materials, as well as the discovery of crystals in some shipments.

At least 19 patients were sickened and nine died in Alabama this year after being infused with a solution through their feeding tubes that was apparently contaminated with bacteria by a pharmacy using an unfamiliar ingredient because of a shortage

Bottom Line

A common knee-jerk reaction is, "See this is what happens when companies control the heath industry. Government needs to be in control."  But look at Russia, Cuba, England for counter examples of lack of care and resources for the common man when the government runs the show.

The solution is greater competition (not patents). But reform is also needed at the FDA level. When regulation is too strict it becomes a barrier to entry and small companies can not compete. Regulation can also ban foreign companies. But too little regulation is also a problem as we know companies will cheat and defraud the consumer with fake or even dangerous drugs.

So how about this. Every day(?) take one random sample from production. Have a competitor test it for quality control. Perhaps monthly have FDA also test a sample to ensure that competitors are not in collusion and hiding bad test results.

When contamination is found, don't fine the company - that is not really a deterrent; that just pushes the fine to the consumer with higher prices. Instead prosecute the CEO for endangering the health of the public. Having a CEO (and other company officers) go to jail seems more effective than paying a fee from company profits. Prosecute for allowing a dangerous drug to be released. Not for intent or ill will. But negligence for failing to adequately test the quality of inputs and outputs. A company must be responsible for the drug it creates - no excuses.

Snake Antivenom Shortage

Genesis 14 God said to the serpent, "Because you have done this, you are cursed above all livestock, and above every animal of the field. On your belly you shall go, and you shall eat dust all the days of your life.
15 I will put enmity between you and the woman, and between your offspring and her offspring. He will bruise your head, and you will bruise his heel."
- World English Bible

On October 31st of this year, the US was scheduled to run out of antivenom for coral snake bites. The sole US manufacturer of the antivenom, Wyeth (now owned by Pfizer), stopped making the drug back in 2003 since, with fewer than 100 coral bites per year, there was no money to be made with this product. Before they shut down the factory, Wyeth made a five year supply to last through 2008. When no new supplier entered the US market, the FDA tested the drug and extended the expiration date to 2009 and then again extended to Oct 31, 2010.

Now the FDA has authorized a third extension for 2011. BUT there may not be 100 does left to last the next year. Hospitals are keeping mum on how much they have left out of fear that their last few doses will be transferred elsewhere.

Corals are the deadliest snakes native to the U.S. They inject a potent neurotoxin by grabbing hold of their prey and gnawing for 20 to 30 seconds with their little teeth. The bite and the poison cause little pain initially, but within hours victims experience slurred speech, droopy eyelids, and eventually the lungs shutdown. Without antivenom victims usually need to be placed on a ventilator or they die.
Corals can be found across the entire southern US from Kentucky, through the Carolinas, Georgia, Louisiana, all of Florida, Texas, Arkansas, Arizona, and New Mexico. The US varieties are most notable for their red, yellow/white, and black colored banding. There some non-poisonous mimic snakes that look like corals but have a different banding pattern:

If red touches yellow - it kills a fellow 
If red touches black, it is a friend of Jack (or it poison lacks)

Bottom Line

The VIPER institute at the University of Arizona is working with the FDA for approval of an antivenom from a Mexican manufacturer. However this won't be easy and will take time. In the meantime - avoid colorful snakes! 

Hamburger Recall

“What good does it do to sit at the counter when you cannot afford a hamburger?"
- Martin Luther King, Jr

I'm dismayed by the number of recalls I see for unsafe products and food. The latest to catch my eye is tons of hamburger meat processed in Pennsylvania. Consumerist.com has the details:

A few tons of ground beef from a meat processor in Pennsylvania have been recalled over fear of possible E. coli contamination. As of early Monday morning, the only retail outlets identified as possibly having received the ground beef were BJ's Wholesale clubs in Connecticut, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York and Virginia.

Since the recalled beef has been repackaged and rebranded it will be tricky to identify. Hopefully the repackaging included the "use/freeze by" date of "07/01/10," and the product code "W69032." Although the use by date has passed, the USDA is concerned that some customers may still have the tainted meat sitting in their freezer.

Bottom Line

See the Consumerist article for a list of stores impacted.

Questions for your Vet

Me and you and a dog named Boo,
Travellin' and livin' off the land.
Me and you and a dog named Boo,
How I love bein' a free man.
- lyrics by Lobo
(I thought it was a dog named Blue, but Boo is correct!)

The FDA has put together a list of questions to ask your vet when medication is prescribed for your pet.

1. Why has my pet been prescribed this medication?

2. How many days do I need to give it? Should I give all of the medication, even if my pet is back to normal?
Some medications, like antibiotics, should be given for a set length of time, even if your pet is feeling better, to prevent creating “superbugs” that are antibiotic resistant.

3. How do I give the medication to my pet? Should it be given with food?
Some medications are best to give on an empty stomach, others have fewer side effects when taken with food.

4. How many times a day and how much should I give each time?

5. If it is a liquid, should I shake it first?

6. How do I store the medication? A cool, dry place or refrigeration?

7. What should I do if my pet vomits or spits out the medication?

8. If I forget to give the medication, should I give it as soon as I remember or wait until the next scheduled dose?

9. What if I accidentally give too much?
You’ll want to know if giving too much will cause serious side effects and require a trip to the animal emergency room.

10. Could this medication interact with other medications my pet is taking?

11. What reactions should I watch for, and what should I do if I see any side effects?

12. When should I bring my pet back for a recheck? Will you call me to check on my pet’s progress, or should I call you?

Bottom Line

It's vital to know the answers to the questions above. And not just for pets! Ask these same questions of your regular doctor the next time you or your children are prescribed medication. (But substitute "child" for "pet" in the questions or you'll get an odd look from your doctor.)

More Misleading Food Labels

More die in the United States of too much food than of too little. ~John Kenneth Galbraith, The Affluent Society

Here are more misleading food label tricks from the Women’s Health magazine article, the “18 Worst Packaged Food Lies”.

Some products use sneaky serving sizes so they can boast, “100 calories a serving!” But check the number of servings listed on your bag of chips, candy bar, etc. Is it 2.6 or any number other than one? Who doesn’t eat the entire bag, or bar, or “individual” frozen pizza? On many cooked foods the official serving size is very small, usually a 1/2 cup for mashed potatoes, stuffing, pasta and similar carbs. I typically eat two or more of these “servings”. My wife & I laugh at processed foods that say "feeds 6-8".

Watch out for fake foods. When something is "strawberry-flavored" or “cheese-flavored” the flavoring will be 100% artificial; i.e. no strawberries or cheese. I once saw a product labeled “authentic pancake syrup”. What does this mean? It was hoping you would think “100% maple syrup” but that product contained no maple and was all sugar. Another product labels itself as “original pizza” and shows a lovely crust covered in cheese and sauce. But there is a reason this product is “original pizza” instead of “cheese pizza”; the “cheese” is imitation mozzarella made from soybean oil. It contains no cheese at all.

“Zero gram tans fats” does not mean trans fats free! Manufactures are allowed to round off so anything less than 0.50 grams is officially zero. To check if a product has trans fats, look in the ingredient list for the words "partially hydrogenated", "shortening", or "interesterified".

The fat fake-out will claim "25% less fat than regular product X". But since fat gives food flavor and texture, something is needed as a substitute. In some cases fat is replaced with maltodextrin, a cheap, carbohydrate filler with empty carbs. Sometimes extra sugar and/or salt supplies the missing flavor. Check the calorie count. You may find that the substitutes are no healthier than the original fat.

"Lightly sweetened" is another unregulated phrase. The Kellogg's Smart Start Cereal is "lightly sweetened" with more added sugars per serving than Froot Loops, Frosted Flakes, or Apple Jacks.

Organic junk food: organic originally meant produce grown without “non-organic” pesticides, insecticides and herbicides. It was sold as healthier and so the word organic became equated with healthy. But this is carried to extremes with Kraft Original Macaroni and Cheese labeled as "USDA organic". Does it matter that the refined flour and powdered cheese is “organic” and then mixed with chemicals in the box? For more information, see The Truth about Organic Food.

Bottom Line

"Food companies are only as honest as the labeling laws force them to be," says a University student in the Chicago Business story, What is 'Real Kraft Cheese'? It notes that “real Kraft cheese” is processed cheese (made in a laboratory, not on a dairy farm) from natural and synthetic ingredients.

The story mentions several food labeling lawsuits:

A woman in California sued Kraft for a “guacamole dip” that contained less than 2% avocado. Kraft’s response? Change the label to a “guacamole flavor dip”.

Quaker’s Strawberries & Cream and their Peaches & Cream Oatmeal contain neither strawberries nor peaches but instead dried apples and artificial color. When challenged in 2001, the labels were changed to indicate artificial ingredients (but the false names remained.)

Ben & Jerry’s had to drop their “all natural” claim when it was discovered that some ice cream contained hydrogenated oil and artificial flavors.

Aunt Jemima Blueberry Waffles mix contains no real blueberries. In 2005 the company agreed to mention “imitation blueberries” on the front of the package.

In General Mills’ Betty Crocker Stir ‘n Bake Carrot Cake Mix, the carrot powder appears last on the ingredient list AFTER salt, cinnamon, red dye and other additives. The company changed the package to say, “with carrot flavored pieces.”

Misleading Food Labels

Don't dig your grave with your own knife and fork. ~English Proverb

Women’s Health magazine has an excellent article on the “18 Worst Packaged Food Lies”.
Always look at what a product has in it, not what it’s “free” of. For example, “Fat Free” does not mean “non-fattening”. Most "fat free" foods are empty-calorie junk foods with 100 percent sugar and processed carbs. In the cartoon above from http://www.xkcd.com/, a product advertises itself as “asbestos free”. Hopefully ALL products are asbestos free so this is just an empty claim to boost sales.

"100% juice pomegranate blueberry” should be read as 100% juice containing some pomegranate and blueberry. The majority of the “juice” is made from apples or white grapes and is little different from sugar water. (See below) In my family we buy 100% juice made from one fruit (i.e. pure pomegranate) and then dilute it 50/50 with Diet 7-Up or similar low calorie mixer. When I was on a diet in college, one of the restricted foods was fruit juice. Whole fruit is healthy and you get pulp and fiber eating apples, etc. But fruit juice packs a lot of calories, can be consumed in bulk, and does not fill you up. Drink it in moderation.

Beware of any product that calls itself a “food” or “drink”. These are words of last resort to hide the fact that the product as little real content and is mostly chemicals. Beverages labeled "juice drink" or "juice cocktail" are primarily sugar water (corn syrup, etc) with a little juice (18%) for flavor. Yoo-Hoo "Chocolate drink" looks like chocolate milk but is really water, high-fructose corn syrup and hydrogenated soybean oil. Nonfat dry milk is listed as the ninth ingredient. A “cheese food” has very little cheese in it. Likewise Macaroni & Cheese “made with real cheese” must contain some cheese but there is no law saying how much or how little. Most of the cheese flavor and texture will be artificial.

The phrase "All Natural Flavors" is not defined by the FDA and means very little. High-fructose corn syrup is a “natural” super sweetener made from corn via some serious chemistry and lab processes. Just because a chemical is extracted from a “natural” source does not make it safe or desirable.

Another unregulated term is “Healthy”. The product line "Healthy Choice" did not pass any tests to earn this title. There is no guarantee that a "Healthy Choice" meal is actually healthy.

Bottom Line

Never trust the product labeling on food; it’s designed to sell you. Look instead at the ingredients list and the calories/fat/etc. The ingredients are listed in order of most content to least and will give you a clue as to whether you are buying “food” or chemicals. But even the ingredient list can be deceiving. Sometimes an ingredient like sugar is broken up into different types to avoid being number 1 on the list. Be worried when you see corn syrup and high-fructose corn syrup and glucose and other sugars all listed separately.

Dangerous Diet Pills

“The second day of a diet is always easier than the first. By the second day you're off it.” - Jackie Gleason

I know a friend who thinks anything labeled “natural” or “herbal” must be safe. But there are “natural” mushrooms that will kill you. A drink of “herbal” hemlock killed the philosopher Socrates. Snake venom is “natural”. So is grapefruit that can cause dangerous side effects with some medicines. For some reason people forget these things when shopping for health and diet supplements.

Worse yet, the labels on health store products may be lying about ingredients. The FDA doesn't screen supplements for safety pre-market — let alone effectiveness. So you have only the “reputation” of the supplier from China or India to go by; the same suppliers that killed children and pets with dangerous additives to milk and pet food.

According to recent tests by the Food and Drug Administration, 69 weight-loss supplements manufactured in the U.S. and abroad contain undeclared pharmaceuticals. For example, nearly all the supplements that tested positive contain the appetite suppressant sibutramine (Meridia), which is illegal to distribute without a prescription. Meridia elevates blood pressure and heart rate and can cause stroke and heart attack. In some supplements, the FDA detected Meridia at four times the highest level that doctors are allowed to prescribe. Without knowing it you may be ingesting drugs at potentially deadly doses.

Many dieters are not aware of the side effects and fail to mention diet pills to their doctor when they experience heart palpitations. Other risks that the FDA discovered in diet pills are an appetite suppressant (rimonabant) that was never approved in the U.S. because of a potential link to depression and suicide, and a laxative (phenolphthalein) linked to cancer in 1999.

Bottom Line

"There is, sadly, a business model," says Marc Ullman, a food-and-drug lawyer in New York. "A company will make insane claims, put a pharmaceutical ingredient in their product, and shut down and start another business if they get caught. What's the worst thing that will happen? A warning letter from the FDA?"

UPDATE

Beware also of "natural" medicines to protect you from Swine Flu. The "cure" can be more dangerous than the disease or even make the flu worse.