Propecia - How Long Is It Valid For?

[repo-man]

I stopped using Propecia about a year ago, but am interested in starting up on it again. I still have a full bottle from a year ago, is it usable? Should I just toss it and get an updated scipt? Also, might be thinking about stepping up to Duta...thoughts?

[repo-man]

I stopped using Propecia about a year ago, but am interested in starting up on it again. I still have a full bottle from a year ago, is it usable? Should I just toss it and get an updated scipt? Also, might be thinking about stepping up to Duta...thoughts?

[Bill - Seemiller]

Repo-man,

 

If Propecia is/was working for you, it may be better to stick with that. Dutasteride will block more DHT, but has the greater potential for side effects.

 

I'm not sure what the shelf life of Propecia is. Is there an indication on the bottle?

 

Best wishes,

 

Bill

[mmhce]

My finasteride tablets have expirary dates of up to 2 years from manufacture dates.

[Flavio]

[...] Also, might be thinking about stepping up to Duta...thoughts?

 

Well, that's the big question. Dutasteride is still a great mystery: it seems to be more effective than finasteride but it hasn't been approved as a hair loss treatment yet and side effects could be serious and permanent. I would advise you to take finasteride and wait until there's more info available.

[repo-man]

Just checked the bottle and the only date I see on there is 7/24/07...so I'm assuming that's the fill date. Do you think its safe to use for the next few months?

 

Yea, going to skip the duta for now and see how the fin works out. What should I expect with the current hair loss pattern I have based on my blog?

[Old Baldy]

IMHO, medications and vitamins, etc., last FAR LONGER than the expiration date. Especially if you store them a a cool, dark place.

[lanthanos]

http://www.essentialdrugs.org/.../200003/msg00076.php

 

March 28, 2000

 

Page One Feature

 

Many Medicines Are Potent Years Past Expiration Dates

 

By LAURIE P. COHEN

Staff Reporter of THE WALL STREET JOURNAL

 

Do drugs really stop working after the date stamped on

the bottle?

 

Fifteen years ago, the U.S. military decided to find

out. Sitting on a $1 billion stockpile of drugs and

facing the daunting process of destroying and

replacing its supply every two to three years, the

military began a testing program to see if it could

extend the life of its inventory.

 

The testing, conducted by the U.S. Food and Drug

Administration, ultimately covered more than 100

drugs, prescription and over-the-counter. The results,

never before reported, show that about 90% of them

were safe and effective far past their original

expiration date, at least one for 15 years past it.

 

In light of these results, a former director of the

testing program, Francis Flaherty, says he has

concluded that expiration dates put on by

manufacturers typically have no bearing on whether a

drug is usable for longer.

 

Mr. Flaherty notes that a drug maker is required to

prove only that a drug is still good on whatever

expiration date the company chooses to set. The

expiration date doesn't mean, or even suggest, that

the drug will stop being effective after that, nor

that it will become harmful.

 

Marketing Issue

 

"Manufacturers put expiration dates on for marketing,

rather than scientific, reasons," says Mr. Flaherty, a

pharmacist at the FDA until his retirement last year.

"It's not profitable for them to have products on a

shelf for 10 years. They want turnover."

 

The FDA cautions that there isn't enough evidence from

the program, which is weighted toward drugs needed

during combat and which tests only individual

manufacturing batches, to conclude that most drugs in

people's medicine cabinets are potent beyond the

expiration date. Still, Joel Davis, a former FDA

expiration-date compliance chief, says that with a

handful of exceptions -- notably nitroglycerin,

insulin and some liquid antibiotics -- most drugs are

probably as durable as those the agency has tested for

the military. "Most drugs degrade very slowly," he

says. "In all likelihood, you can take a product you

have at home and keep it for many years, especially if

it's in the refrigerator."

 

Manufacturers' View

 

Drug-industry officials don't dispute the results of

the FDA's testing, within what is called the Shelf

Life Extension Program. And they acknowledge that

expiration dates have a commercial dimension. But they

say relatively short shelf lives make sense from a

public-safety standpoint, as well.

 

New, more-beneficial drugs can be brought on the

market more easily if the old ones are discarded

within a couple of years, they say. Label redesigns

work better when consumers don't have earlier versions

on hand to create confusion. From the companies'

perspective, any liability or safety risk is

diminished by limiting the period during which a

consumer might misuse or improperly store a drug.

 

"Two to three years is a very comfortable point of

commercial convenience," says Mark van Arandonk,

senior director for pharmaceutical development at

Pharmacia & Upjohn Inc. "It gives us enough time to

put the inventory in warehouses, ship it and ensure it

will stay on shelves long enough to get used." But

companies uniformly deny any effort to spur sales

through planned obsolescence.

 

Why Not Longer?

 

Now that the FDA has found that many drugs are still

good long after they have supposedly expired, why

doesn't it advocate later expiration dates for

consumer drugs? One reason is that the consumer market

lacks the military's logistical reasons to keep drugs

around longer.

 

Frank Holcombe, associate director of the FDA's office

of generic drugs, says that in many cases a

manufacturer could extend expiration periods again and

again, but to support those extensions, it would have

to keep doing stability studies, and keep more in

storage than it would like.

 

Mr. Davis adds: "It's not the job of the FDA to be

concerned about a consumer's economic interest." It

would be up to Congress to impose changes, he says.

 

As things stand now, expiration dates get a lot of

emphasis. For instance, there is a campaign,

co-sponsored by some drug retailers, that urges people

to discard pills when they reach the date on the

label.

 

And that date often is even earlier than the one the

maker set. That's because when pharmacists dispense a

drug in any container other than what it came to them

in, they routinely cut the expiration date to just one

year after dispensing. Some states even require

pharmacists to do this.

 

Meanwhile, poor countries -- under urging from the

World Health Organization -- often reject drug-company

donations of much-needed medicines if they are within

a year of their expiration dates.

 

It isn't known how much of the $120 billion-plus spent

annually in the U.S. on prescription and

over-the-counter medicines goes to replace expired

ones. But in a poll done for The Wall Street Journal

by NPD Group Inc. of Port Washington, N.Y., 70% of

1,000 respondents said they probably wouldn't take a

prescription drug after its expiration date; 72% said

the same of an over-the-counter remedy.

 

"People think that, upon expiration, drugs suddenly

turn toxic or lose all their potency," says Philip

Alper, professor of medicine at University of

California at San Francisco. In his own practice, Dr.

Alper says, "I frequently hear -- from patients who

can't afford medicine -- that they have thrown away

expired drugs." He says companies should be required

to test drugs for longer periods and set later

expiration dates when results warrant.

 

Some manufacturers first began putting expiration

dates on drugs in the 1960s, although they didn't have

to. When the FDA began requiring such dating in 1979,

the main effect was to set uniform testing and

reporting guidelines. As now required by the FDA,

so-called stability testing analyzes the capacity of a

drug to maintain its identity, strength, quality and

purity for whatever period the manufacturer picks. If

the company picks a two-year expiration date, it

needn't test beyond that.

 

Testing for a two-year expiration doesn't initially

entail holding a drug for two years. Rather, the drug

is tested by subjecting it to extreme heat and

humidity for several months, then chemically analyzing

each ingredient's identity and strength. (After the

date is set and the drug is marketed, testing

continues for the full two years.)

 

The FDA also uses chemical analysis in testing for

possible shelf-life extension; it doesn't test on

human subjects. Testing conditions are such that any

medicine that meets, say, the standards for a two-year

expiration date probably lasts longer, the FDA and

drug companies agree.

 

Still Good

 

Consider aspirin. Bayer AG puts two-year or three-year

dates on aspirin and says that it should be discarded

after that. Chris Allen, a vice president at the Bayer

unit that makes aspirin, says the dating is "pretty

conservative"; when Bayer has tested four-year-old

aspirin, it remained 100% effective, he says.

 

So why doesn't Bayer set a four-year expiration date?

Because the company often changes packaging, and it

undertakes "continuous improvement programs," Mr.

Allen says. Each change triggers a need for more

expiration-date testing, he says, and testing each

time for a four-year life would be impractical.

 

Bayer has never tested aspirin beyond four years, Mr.

Allen says. But Jens Carstensen has. Dr. Carstensen,

professor emeritus at the University of Wisconsin's

pharmacy school, who wrote what is considered the main

text on drug stability, says, "I did a study of

different aspirins, and after five years, Bayer was

still excellent. Aspirin, if made correctly, is very

stable."

 

Only one report known to the medical community linked

an old drug to human toxicity. A 1963 Journal of the

American Medical Association article said degraded

tetracycline caused kidney damage. Even this study,

though, has been challenged by other scientists. Mr.

Flaherty says the Shelf Life program encountered no

toxicity with tetracycline and typically found batches

effective for more than two years beyond their

expiration dates.

 

Plea From the Air Force

 

The program dates to a U.S. effort begun in 1981 to

increase military readiness by buying large quantities

of drugs and medical devices for the armed forces.

Four years later, more than $1 billion of supplies had

been stockpiled. The General Accounting Office audited

Air Force troop hospitals in Europe and found many

supplies at or near expiration. It warned that by the

1990s, more than $100 million would have to be spent

yearly on replacements.

 

The Air Force Surgeon General's office asked the FDA

if it could possibly extend the shelf life of these

drugs. The FDA had the equipment for stability

testing. And because it had approved the drugs' sale

in the first place, it also had manufacturers' data on

the testing protocols.

 

Testing for the Air Force began in late 1985. In the

first year, 58 medicines from 137 different

manufacturing lots were shipped to the FDA from

overseas storage, among them penicillin, lidocaine and

Lactated Ringers, an intravenous solution for

dehydration. After testing, the FDA extended more than

80% of the expired lots, by an average of 33 months.

 

In 1992, according to the FDA, more than half of the

expired drugs that had been retested in 1985 were

still fine. Even now, at least one still is.

 

Such results came as a revelation for Army Col. George

Crawford when he took over military oversight of the

program in 1997. He is a pharmacist, but "nobody tells

you in pharmacy school that shelf life is about

marketing, turnover and profits," he says. (The drug

makers don't agree that it is, however.)

 

How It Works

 

The military's base for the program is a dingy

barracks room in Fort Detrick, Md. There, a group

headed by Air Force Lt. Col. Greg Russie, who recently

took over from Col. Crawford, tracks drugs that are

near expiration at defense facilities all over the

world, selecting many for retesting. They are shipped

to the FDA, which sends them to its laboratories.

 

The FDA's lab in Philadelphia recently tested five

automatic injectors containing an antidote to chemical

poisoning, which were purposely held for three months

in conditions even hotter and more humid than the FDA

requires in consumer testing of drugs. The FDA tested

the drug contained in the injectors, pralidoxime

chloride, by separating its ingredients and measuring

the strength and quality of each, then applying a

computer model to determine whether a shelf-life

extension was warranted.

 

The injectors' original expiration date was November

1985. The FDA had retested them periodically ever

since, each time approving their continued use. The

batch, made by Ayerst Laboratories, now part of

American Home Products Corp.'s Wyeth-Ayerst unit, is

18 years old. It is 15 years beyond the expiration

date applied by Ayerst. The FDA found it is still

good.

 

A spokesman for Wyeth-Ayerst says it "uses scientific

data to establish expiration dates" and "tries to have

the longest possible dating on products that

scientific data supports." The company is aware of the

FDA retesting program. It says it can't comment

specifically on the injectors tested by the FDA.

 

A Few Fail

 

Shelf-life extensions are "intentionally

conservative," the FDA's Mr. Flaherty told military

brass in a 1992 speech. He says that if the agency

extended an expiration date by 36 months, it had

concluded the lot would retain all of its safety and

efficacy for at least 72 months.

 

A very few drugs aren't retested. The military has

found that water-purification tablets and mefloquine

hydrochloride, for malaria, routinely fail stability

testing beyond their expiration dates, so it has

removed them from the program.

 

Also excluded are large-volume intravenous solutions,

such as saline. "We don't like to test those," says

Col. Crawford. "Not because we can't, but because it

would be politically sensitive if G.I. Joe was lying

in bed and saw it had originally expired three years

ago."

 

Mr. Flaherty has said that while he tested a handful

of drug batches that didn't even make it to their

expiration dates, most drugs were "surprisingly

durable." In one instance, he says, drugs labeled for

room-temperature storage had been kept for two years

in a warehouse in Oman that averaged 135 degrees

Fahrenheit in the daytime. Upon expiration, the drugs,

which included the local anesthetic lidocaine and

atropine, a nerve-gas antidote also used by eye

doctors to dilate pupils, "were well within the

standards for potency and other quality

characteristics," he says.

 

Stable Molecule

 

One medicine the FDA has endorsed for extensions is

ciprofloxacin hydrochloride tablets, an antibiotic

marketed by Bayer as Cipro. One batch had an

expiration date of March 1989. More than 9 1/2 years

later, the FDA found the tablets still good; it then

extended some of them for 18 more months and others

for 24 more months.

 

Albert Poirier, quality-assurance director for Bayer's

pharmaceutical division, says he isn't surprised

because Cipro "is a stable drug molecule" in tablet

form. "We go for a shelf life that will be safest for

patients," he says. "We want the drug to be used up

within three years. We wouldn't want a patient to have

it for 10 years because they'd have an old package

insert" that might omit new information or

contra-indications and because "we'd have no control

over how they'd store the drug during this time."

 

Another extended drug is Thorazine, a tranquilizer

chemically known as chlorpromazine tablets. Batches

bearing December 1996 expiration dates -- unused and

unopened, as is the case with all drugs evaluated in

the Shelf Life program -- were tested in July 1998 and

extended for two years. A spokesman for the maker,

SmithKline Beecham PLC, says it applies an expiration

date 24 months after manufacture. "We think that is

the appropriate expiration date," he says. "We don't

benefit from short expiration dates."

 

Some other drugs the FDA has extended at least two

years beyond their expiration dates are diazepam, sold

as Valium; cimetidine, sold as Tagamet; phenytoin,

sold as Dilantin; and the antibiotics tetracycline and

penicillin.

 

Big Savings

 

On a cost-benefit basis, the program's returns have

been huge. The first year, the Air Force paid the FDA

$78,000 for testing and saved 59 times that sum by not

needing to replace the drugs. After other services

joined, the military from 1993 through 1998 spent

about $3.9 million on testing and saved $263.4 million

on drug expense, according to Lt. Col. Russie.

 

Says Mr. Flaherty: "We've cost the pharmaceutical

companies hundreds of millions of dollars in sales of

new stuff to the Department of Defense."

 

More than 12 years ago, Messrs. Flaherty and Davis

explained the program to drug-company chemists at a

meeting of the American Association of Pharmaceutical

Scientists in Woodbridge, N.J., going into detail

about how the FDA decided whether to extend a given

expiration date. Mr. Davis concluded by noting how

much the U.S. had saved by extending shelf lives

instead of "destroying large quantities of

still-useful medical products... ."

 

Mr. Flaherty says the FDA was keenly aware that if its

methodology was flawed, or its results incorrect even

once, its credibility would be attacked. Yet FDA

officials say that during the program's 15 years, drug

makers have never objected to any of its procedures or

findings. "They may not have liked what we were doing,

but they weren't able to challenge it," he says.

 

The Message to Civilians

 

While the military is finding it can keep most drugs

longer, civilians hear quite a different message. For

instance, a campaign called the National Expired and

Unused Medication Drive has collected and destroyed 36

tons of drugs since 1991, says its founder, Kathilee

Champlin. Ms. Champlin, of Colorado Springs, Colo.,

says her interest derives from experience working with

the elderly and seeing how hard it was for them to

keep track of all their medications. She says she

wasn't aware of any FDA program to extend drugs' shelf

lives.

 

Her group has gained sponsorship from the some big

drug retailers, including Wal-Mart Stores Inc. It

sponsors the campaign to be "a good corporate

citizen," says Frank Seagrave, vice president of

pharmacy merchandising. "We believe that people should

dispose of unused prescription medicines a year after

they get them," he says, adding that Wal-Mart

sometimes gives people a free bottle of vitamins if

they bring in expired drugs.

 

Johnson & Johnson's Janssen Pharmaceutica unit, a drug

maker, also sponsors Ms. Champlin's campaign. "We

think it's important to educate the public about the

risk of taking drugs that are expired and to raise

public awareness," says a spokesman for Janssen. Both

Wal-Mart and J&J say that supporting the campaign to

discard expired drugs has nothing to do with their

sales efforts.

 

Many pharmacists also play a role in shelf lives. The

U.S. Pharmacopeia, a not-for-profit scientific group

that develops standards for the drug industry, urged

in 1985 that pharmacists set expiration dates at no

more than one year if they were dispensing drugs in a

bottle other than the manufacturer's original

packaging. "New containers may let in more moisture

and heat than the container the manufacturer used for

the stability study," accelerating the drug's

degradation, says the USP General Counsel Joseph

Valentino.

 

The recommendation became a USP requirement in 1997.

As a result, "the majority of pharmacists shorten the

manufacturers' expiration dates" on prescription drugs

to one year or less, says Susan Winckler, an official

of the American Pharmaceutical Association. In fact,

in 17 states, pharmacists now are legally required to

do so. Ms. Winckler says shortening the dates makes

sense because many people store drugs in moist

bathrooms. She says the one-year rule is "motivated by

product integrity and not by profit."

 

Even the FDA has sometimes pushed for throwing out

drugs at their expiration date. Last October it

co-sponsored, with the National Association of Chain

Drugstores and others, a campaign that urged women not

to use medications beyond the expiration dates

because, as the brochure put it, "they may not work."

Mr. Davis says this shows just how obscure the

military Shelf Life Extension Program is. "Many people

at the FDA have absolutely no idea this program

exists," he says.

 

Write to Laurie P. Cohen at laurie.cohen@wsj.com