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?

Side Effects

“America is the country where you buy a lifetime supply of aspirin for one dollar and use it up in two weeks”
-John Barrymore

All medicines can cause side effects. And sometimes one medicine is prescribed over another because of the side effects. For example, I recently saw a doctor about back pain and she recommended an odd (to me) schedule of medicine. Advil at breakfast, Tylenol at lunch, Advil at dinner, and Tylenol before sleeping. Why the two different pain killers I asked? She explained:

Advil and similar Ibuprofen products can upset the stomach, and according to Drugs.com, cause constipation, diarrhea, dizziness, gas, headache, heartburn, and nausea. Since I have GERD (acid reflux) I have to go easy on the Advil.

Tylenol is easy on the stomach but there are strict limits on its usage. This is not a drug you want to overdose on, it can be fatal. USA Today reports a study that claims even small overdoses of Tylenol repeated over time can damage the liver.  Many people I know will take extra aspirin or Ibuprofen when the regular dosage did not kill the pain. But few are aware that they should NEVER exceed the recommended dosage Tylenol, no matter how bad the pain is.

Bottom Line

Never just assume that if a little medicine is good than more must be better. Always check with a doctor if the recommended dose is not doing the job you want.

What a Pill

One pill makes you larger
And one pill makes you small
And the ones that mother gives you
Don't do anything at all
Go ask Alice
When she's ten feet tall
-"White Rabbit" by Jefferson Airplane

In contrast to the lyrics above, the pills that mother takes can be quite dangerous when eaten by a small child. A study in the Journal of Pediatrics looked at data from the American Association of Poison Control Centers, and found that child poisoning from prescription drugs was up 30% between 2001 and 2008. The likely source of the problem is that “there are more medications in households with small children”. Doctors are prescribing pills to everyone for everything and at increasing younger ages. Young parents are now taking opioid painkillers, sedative-hypnotics like muscle relaxants and sleep aids, and cardiovascular medicines. And while one, large pill a day is great for the adult, that large pill means a massive overdose when swallowed by a toddler.

Keep drugs out of reach. Preferable behind a locked cabinet.

Bottom Line

Many years ago as a teen-aged babysitter I was reading a book while the toddler slept (or so I thought). When the parents came home and checked the child, they found his mouth covered in white. It seems he had left his crib, found some aspirin, and decided to eat them. I had no clue this was happening. (I was not hired by that family again.)

Smuggling Drugs in Unwitting People's Car Trunks

Woh, down in Mexico, I never really been so I don't really know.
And oh, Mexico, I guess I'll have to go.
-James Taylor, lyrics from Mexico

Schneier on Security has this is clever but scary story:

A few miles away across the Rio Grande, the FBI determined that Chavez and Gomez were using lookouts to monitor the SENTRI Express Lane at the border. The lookouts identified "targets" -- people with regular commutes who primarily drove Ford vehicles. According to the FBI affidavit, the smugglers would follow their targets and get the vehicle identification number off the car's dashboard. Then a corrupt locksmith with access to Ford's vehicle database would make a duplicate key. Keys in hand, the gang would put drugs in a car at night in Mexico and then pick up their shipment from the parked vehicle the next morning in Texas, authorities say.

A reader made an interesting comment at Schneier's site; with the duplicate key the smugglers could have easily stolen the cars. Apparently there is more money to be made in drug shipments than in selling a stolen car.

Bottom Line

People who smuggle goods are called mules and not every mule is aware that they are smuggling. Hence the questions at airports - did you pack your own bag? Did anyone give you something to carry on board? Etc.

Never leave your bags out of sight when traveling. A clever crook could slip something into your bag. They won't get caught when the illegal item is found on you. And if you do manage to get through the boarder, the crook or his/her accomplice will steal your bag on the other side.

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! 

Caffeine

Way too much coffee. But if it weren't for the coffee, I'd have no identifiable personality whatsoever. ~David Letterman

How much caffeine do you consume a day? It may be more than you think. Some sweets and over-the-counter medications have caffeine (note Excedrin at the top of the chart below.) Sunkist Orange soda has more caffeine than Pepsi or Coke.

The MayoClinc says most people can handle 200-300 milligrams a day although there are individuals that are affected by as little as one cup of coffee, 100 mg. At levels of 500-600 mg/day you may see the following side effects:

· Headaches
· Irritability
· Anxiety
· Nervousness
· Restlessness
· Insomnia
· Nausea or other gastrointestinal problems
· Muscle tremors
· Fast or irregular heartbeat

Caffeine can be addictive. As the brain gets used to the drug, it takes ever more caffeine for the same energy “boost”. Caffeine withdrawal results once a person stops consuming caffeine. Withdrawal symptoms are consistent with other drugs, but without the life-threatening severity of alcohol or Valium withdrawal. Caffeine withdrawal typically begins within 24 hours and can last for a week or more with these symptoms:

· Headaches
· Irritability
· Anxiety
· Fatigue

Ironic huh – the top three symptoms can result from too much caffeine or too little.

Product	Size in Oz.	Total Caffeine in mg
Excedrin, Extra Str,	2 tablets	130
Mountain Dew Game Fuel	20	120
Brewed coffee	8	60-120
Double espresso	2	45-100
Snapple Elements	18	108
Ben & Jerry's Coffee Fudge Frozen Yogurt	8	85
Red Bull	8.5	80
Instant coffee	8	70
Tea - black	8	45-60
Mountain Dew	12	55
Lipton Iced Teas	20	50
TaB	12	47
Diet Coca Cola	12	45
RC Cola	12	43
Sunkist Orange Soda	12	41-42
Dr. Pepper	12	41
Pepsi	12	38
Coke Classic	12	35
Dark Chocolate bar	1.45	31
A&W Cream Soda	12	29
Barq's Root Beer	12	22
Tea - green	8	20
Tea - white	8	15
Chocolate Bar	1.55	9
Chocolate milk	8	5
Hot Chocolate	8	5
Decaf coffee	8	1-5
Herbal Tea	8	0
7-up, Fanta, Fresca, Sprite	12	0
Yoo-Hoo Chocolate	8	0

Bottom Line

Use the chart above get a perspective on the caffeine strength of common items. Suppose you want to set a limit of 100mg per day. That would mean a limit of 1 coffee, 3 Cokes, 4 Root Beers, 11 Milk Chocolate bars or 20 glasses of chocolate milk.

Resources

http://coffeetea.about.com/library/blcaffeine.htm
http://www.energyfiend.com/the-caffeine-database
http://www.mayoclinic.com/health/caffeine/AN01211
http://www.mayoclinic.com/health/caffeine/NU00600
http://www.myaddiction.com/education/articles/caffeine_addiction.html

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.