Many experts say pills may work long after expiration date

[Guest guest]

Many experts say pills may work long after expiration date

By Bob LaMendola

South Florida Sun-Sentinel Health Writer

December 17, 2006

If Jane Kreimer's medicines were library books, she'd be fined for

late returns. Her sleeping pills expired in 2000. Her pain pills and

excess-fluid pills expired in 2004.

But the Fort Lauderdale retiree said she hasn't replaced them, because

a doctor told her to save the money and take the out-of-date drugs as

long as they did the job. " They're still working, " Kreimer said. " What

a terrible waste it is for people to throw drugs away. I bet they're

making millions, if not billions, from people throwing out perfectly

good medication. "

A growing body of studies and experts back her, asserting that many

medicines remain safe, effective and stable for years beyond

government-approved expiration dates set by drugmakers and pharmacists.

The leading evidence comes from a U.S. Food and Drug Administration

program that tests drugs for the military. The results through July

2006: 88 percent of tested medicines remained potent for at least a

year past expiration, some for up to 14 years.

Many officials from the FDA, drug industry and research community

agree that certain medications, such as aspirin, may remain good well

past expiration.

Even so, some of those experts discourage taking expired drugs, saying

they are not a sure thing. The military stores drugs under ideal cool

and dry conditions, these experts say, but consumers may not, creating

a risk that old drugs will lose potency.

" After the manufacturer's expiration, don't use it, no matter what the

government says, " said Skip Lenz, owner of Skip's Pharmacy in Boca

Raton. " Beyond that, it's a crapshoot. "

The controversy has waged for more than a decade, dragging Florida

drug chains into court and pushing the state to alter its pharmacy rules.

Expiration dates are set by the manufacturer and approved by the FDA

based on company tests of a drug. The company guarantees the product

will be at least 90 percent potent until the expiration date. Most

drugs get a one- or two-year life.

Drugmakers can ask to extend the expiration if they test the drug

further. But companies seldom do, industry officials said, because the

tests take money and time, and do not lead to extra sales.

So, while aspirin is marked to expire in two or three years, Bayer has

found its pills to be 100 percent potent after four years, said Dr.

Jens Carstensen, a retired pharmacy professor in Wisconsin who wrote

textbooks on drug shelf life. He tested five-year-old aspirin and

found it to be " excellent. "

Ormond Beach pharmacist Gerald , who has made the issue a

crusade, said companies lowball expiration dates so consumers buy new

drugs.

" We should tell people to throw away a $300 bottle of pills because of

a marketing scheme? " said. " Even the manufacturers don't know

when their drugs expire. Here's the government sanctioning a big lie. "

A spokesman for the pharmaceutical industry denied that drugmakers set

expirations to boost sales. The dates must be conservative to ensure

drugs work no matter how they are stored, said Alan Goldhammer, vice

president for the trade group Pharmaceutical Research and

Manufacturers of America.

Many consumers keep their drugs in the bathroom, exposed to heat and

humidity that degrade drugs, Goldhammer said.

" I don't think money is the consideration at all, " he said. " [Drugs]

could still be good after the date but there's no guarantee. "

The FDA does not make manufacturers test drugs for a longer time to

find the true life span, because its priority is safety and

effectiveness, not saving money for consumers, an agency spokeswoman said.

Certain drugs -- nitroglycerin for heart disease, liquid antibiotics

and others -- are prone to degrade fast and must be watched, experts said.

Yet research shows many last for years:

The FDA Shelf Life Extension Program has tested hundreds of drugs for

the U.S. military since 1985 and found that, on average, they were

good for 51/2 years after expiration. The program saved $296 million

on drug replacements in 2005 alone, the FDA said.

Anesthetic lidocaine was found to be good past the expiration despite

being stored for two years in an Oman warehouse at up to 135 degrees.

Antibiotic ciprofloxacin marked to expire in three years was still

good after 13. Cyanide antidote sodium thiosulfate was still good

after 16 years.

The findings are clouded, the FDA says, because a few batches of

long-lived drugs degraded before expiration.

Flu drugs amantadine and rimantadine stored for 25 years under

household conditions proved to be fully effective, doctors said in a

1998 study in Antiviral Research.

The asthma drug theophylline proved to be 90 percent potent after 35

years, doctors said in a 2002 study in Human & Experimental Toxicology.

A Massachussetts Institute of Technology researcher, Moshe Alamaro,

insists expiration dates are inaccurate, and is lobbying for state

approval to collect unopened, expired medicine for the uninsured.

Alamaro said supporters may follow suit in other states, including

Florida.

In general, pharmacy experts consider a medicine good at 90 percent

potency, but author Carstensen said some drugs -- such as painkillers,

cold remedies and others that simply relieve symptoms -- work fine at

85 percent or less. He said he eased a migraine with a drug six years old.

Yet he and others urge caution, saying consumers cannot tell which

drugs were stored well enough to be good after expiration.

Some pharmacy specialists call for the FDA or drug companies to test

drugs for longer periods, to possibly set longer expirations to

benefit consumers, insurers and tax-supported Medicare and Medicaid.

" With medicines being so high, it would be nice if the government

would pay for a study. It could save millions or billions, " said Dr.

Jay Pomerantz, a Harvard professor who favors recycling expired drugs.

The industry calls the idea a non-starter. Why would a company spend

time and money testing a drug's shelf life when its patent expires

after a number of years, Goldhammer said. Most medicines, he added,

are given in quantities that should be taken fully to treat the

illness, with no leftovers.

Some drug experts argue that aged drugs can break down into harmful

byproducts, citing a 1963 study on a death from old tetracycline. But

the editor of Harvard Health Letter wrote in 2003 that the old study

is in dispute and that cases of old drugs causing harm are " virtually

unknown. "

Manufacturer expirations are not the only source of controversy. About

17 states require pharmacists to put a one-year date on a prescription

if the pills were removed from a factory container -- even if the

official expiration is later -- on the theory that medicine may

degrade in drugstore vials. The one-year date is backed by influential

U.S. Pharmacopeia, which sets standards for the drug industry.

Florida's pharmacy board had imposed the one-year rule for years until

critics complained. In 2004, the board let pharmacists decide between

one year and the factory date. Yet many of Florida's 22,500

pharmacists don't know of the change or use computers still programmed

for one-year labels, said Elias, owner of the Prescription Pad

and president of the Broward Pharmacy Association.

The state pharmacy board doesn't track pharmacists' labeling and takes

no position on expiration dates, board Director Poston said.

Florida's biggest drug chains, Walgreens and CVS, follow the one-year

rule unless pills are in a factory package, company spokespersons said

-- and they have been sued.

A 2004 class-action suit in Chicago's Cook County calls Walgreens'

policy deceptive, said Ben Barnow, an attorney who filed it. A similar

suit against CVS was dismissed but another is pending.

Clearly, the issue of expiration dates is far from settled.

" Each drug has to be looked at individually, " said Larry Sasich, a

pharmacy professor and consultant for Public Citizen Health Research

Group. " It sounds like it should be simple, but it's not. "

http://www.sun-sentinel.com/features/health/sfl-rxexpire17dec17,0,62392.story

[Guest guest]

Thanks for this, Lee. J Tamarin

From: Flu [mailto:Flu ] On Behalf Of Lee

Sent: Sunday, December 17, 2006

6:03 AM

Flu

Subject: [Flu] Many

experts say pills may work long after expiration date

Many experts say pills may work long after expiration

date

By Bob LaMendola

South Florida Sun-Sentinel Health Writer

December 17, 2006

If Jane Kreimer's medicines were library books, she'd be fined for

late returns. Her sleeping pills expired in 2000. Her pain pills and

excess-fluid pills expired in 2004.

But the Fort Lauderdale

retiree said she hasn't replaced them, because

a doctor told her to save the money and take the out-of-date drugs as

long as they did the job. " They're still working, " Kreimer said.

" What

a terrible waste it is for people to throw drugs away. I bet they're

making millions, if not billions, from people throwing out perfectly

good medication. "

A growing body of studies and experts back her, asserting that many

medicines remain safe, effective and stable for years beyond

government-approved expiration dates set by drugmakers and pharmacists.

The leading evidence comes from a U.S. Food and Drug Administration

program that tests drugs for the military. The results through July

2006: 88 percent of tested medicines remained potent for at least a

year past expiration, some for up to 14 years.

Many officials from the FDA, drug industry and research community

agree that certain medications, such as aspirin, may remain good well

past expiration.

Even so, some of those experts discourage taking expired drugs, saying

they are not a sure thing. The military stores drugs under ideal cool

and dry conditions, these experts say, but consumers may not, creating

a risk that old drugs will lose potency.

" After the manufacturer's expiration, don't use it, no matter what

the

government says, " said Skip Lenz, owner of Skip's Pharmacy in Boca

Raton. " Beyond that, it's a crapshoot. "

The controversy has waged for more than a decade, dragging Florida

drug chains into court and pushing the state to alter its pharmacy rules.

Expiration dates are set by the manufacturer and approved by the FDA

based on company tests of a drug. The company guarantees the product

will be at least 90 percent potent until the expiration date. Most

drugs get a one- or two-year life.

Drugmakers can ask to extend the expiration if they test the drug

further. But companies seldom do, industry officials said, because the

tests take money and time, and do not lead to extra sales.

So, while aspirin is marked to expire in two or three years, Bayer has

found its pills to be 100 percent potent after four years, said Dr.

Jens Carstensen, a retired pharmacy professor in Wisconsin who wrote

textbooks on drug shelf life. He tested five-year-old aspirin and

found it to be " excellent. "

Ormond Beach

pharmacist Gerald , who has made the issue a

crusade, said companies lowball expiration dates so consumers buy new

drugs.

" We should tell people to throw away a $300 bottle of pills because of

a marketing scheme? " said. " Even the manufacturers don't know

when their drugs expire. Here's the government sanctioning a big lie. "

A spokesman for the pharmaceutical industry denied that drugmakers set

expirations to boost sales. The dates must be conservative to ensure

drugs work no matter how they are stored, said Alan Goldhammer, vice

president for the trade group Pharmaceutical Research and

Manufacturers of America.

Many consumers keep their drugs in the bathroom, exposed to heat and

humidity that degrade drugs, Goldhammer said.

" I don't think money is the consideration at all, " he said.

" [Drugs]

could still be good after the date but there's no guarantee. "

The FDA does not make manufacturers test drugs for a longer time to

find the true life span, because its priority is safety and

effectiveness, not saving money for consumers, an agency spokeswoman said.

Certain drugs -- nitroglycerin for heart disease, liquid antibiotics

and others -- are prone to degrade fast and must be watched, experts said.

Yet research shows many last for years:

The FDA Shelf Life Extension Program has tested hundreds of drugs for

the U.S.

military since 1985 and found that, on average, they were

good for 51/2 years after expiration. The program saved $296 million

on drug replacements in 2005 alone, the FDA said.

Anesthetic lidocaine was found to be good past the expiration despite

being stored for two years in an Oman warehouse at up to 135

degrees.

Antibiotic ciprofloxacin marked to expire in three years was still

good after 13. Cyanide antidote sodium thiosulfate was still good

after 16 years.

The findings are clouded, the FDA says, because a few batches of

long-lived drugs degraded before expiration.

Flu drugs amantadine and rimantadine stored for 25 years under

household conditions proved to be fully effective, doctors said in a

1998 study in Antiviral Research.

The asthma drug theophylline proved to be 90 percent potent after 35

years, doctors said in a 2002 study in Human & Experimental Toxicology.

A Massachussetts Institute of Technology researcher, Moshe Alamaro,

insists expiration dates are inaccurate, and is lobbying for state

approval to collect unopened, expired medicine for the uninsured.

Alamaro said supporters may follow suit in other states, including

Florida.

In general, pharmacy experts consider a medicine good at 90 percent

potency, but author Carstensen said some drugs -- such as painkillers,

cold remedies and others that simply relieve symptoms -- work fine at

85 percent or less. He said he eased a migraine with a drug six years old.

Yet he and others urge caution, saying consumers cannot tell which

drugs were stored well enough to be good after expiration.

Some pharmacy specialists call for the FDA or drug companies to test

drugs for longer periods, to possibly set longer expirations to

benefit consumers, insurers and tax-supported Medicare and Medicaid.

" With medicines being so high, it would be nice if the government

would pay for a study. It could save millions or billions, " said Dr.

Jay Pomerantz, a Harvard professor who favors recycling expired drugs.

The industry calls the idea a non-starter. Why would a company spend

time and money testing a drug's shelf life when its patent expires

after a number of years, Goldhammer said. Most medicines, he added,

are given in quantities that should be taken fully to treat the

illness, with no leftovers.

Some drug experts argue that aged drugs can break down into harmful

byproducts, citing a 1963 study on a death from old tetracycline. But

the editor of Harvard Health Letter wrote in 2003 that the old study

is in dispute and that cases of old drugs causing harm are " virtually

unknown. "

Manufacturer expirations are not the only source of controversy. About

17 states require pharmacists to put a one-year date on a prescription

if the pills were removed from a factory container -- even if the

official expiration is later -- on the theory that medicine may

degrade in drugstore vials. The one-year date is backed by influential

U.S. Pharmacopeia, which sets standards for the drug industry.

Florida's

pharmacy board had imposed the one-year rule for years until

critics complained. In 2004, the board let pharmacists decide between

one year and the factory date. Yet many of Florida's 22,500

pharmacists don't know of the change or use computers still programmed

for one-year labels, said Elias, owner of the Prescription Pad

and president of the Broward Pharmacy Association.

The state pharmacy board doesn't track pharmacists' labeling and takes

no position on expiration dates, board Director Poston said.

Florida's

biggest drug chains, Walgreens and CVS, follow the one-year

rule unless pills are in a factory package, company spokespersons said

-- and they have been sued.

A 2004 class-action suit in Chicago's Cook County

calls Walgreens'

policy deceptive, said Ben Barnow, an attorney who filed it. A similar

suit against CVS was dismissed but another is pending.

Clearly, the issue of expiration dates is far from settled.

" Each drug has to be looked at individually, " said Larry Sasich,

a

pharmacy professor and consultant for Public Citizen Health Research

Group. " It sounds like it should be simple, but it's not. "

http://www.sun-sentinel.com/features/health/sfl-rxexpire17dec17,0,62392.story