***FDA Uncovers More Fake Lipitor (Check with your pharmacist!!!)

Kansas City Star ^ | June 3, 2003 | LAURAN NEERGAARD

[FairOpinion]

WASHINGTON - Federal investigators discovered more than 30,000 additional bottles of fake Lipitor, a top-selling anti-cholesterol pill, as they worked Tuesday to crack a huge case of medical counterfeiting.

Also Tuesday, the manufacturer of real Lipitor, Pfizer Inc., filed suit to stop a pharmaceutical repackaging company and distributor from selling any more fake pills - and to get more information to track the counterfeit's source.

Repackager Med-Pro Inc. and Albers Medical Distributors both denied involvement in the counterfeiting.

The Food and Drug Administration first uncovered three batches of fake Lipitor almost two weeks ago, and ordered Kansas City-based Albers to recall 100,000 bottles. Tuesday, the FDA announced it had turned up three more batches containing counterfeit pills.

The FDA warned Lipitor users and pharmacists Tuesday to carefully check their bottles before using Lipitor. To spot the fake version, look for the words "Repackaged by MED-PRO Inc., Lexington, NE 68850" on 90-tablet bottles that bear any of the following lot numbers:

_20842V, expiration 09-2004

_16092V, expiration 07-2004

_20722V, expiration 09-2004

_04132V, expiration 01-2004

_16942V, expiration 09-2004

_D270481, expiration not available.

All but that last batch are 10-milligram tablets; the last one includes 20-milligram tablets.

Many patients taking Lipitor buy it in smaller quantities dispensed in different bottles by their local drugstore. So patients not sure if they have the counterfeit version should call their pharmacist, who can check the pills' source, the FDA advised.

"We want consumers, if there's any doubt at all, to call their pharmacist," said FDA Associate Commissioner John Taylor.

Pfizer says the fake Lipitor pills bear a close resemblance to real Lipitor, although they may be slightly thicker. Consumers have reported that the fake pills dissolve faster and have a slightly bitter taste. In fact, a handful of consumer complaints about the taste prompted the FDA's probe.

Drug manufacturers typically sell their products to a wholesaler that can in turn send tablets directly to pharmacies, or to a distributor and repackager before they arrive at drugstores.

Pfizer sued Med-Pro and Albers on Tuesday, saying it has no relationship with either of the companies so far identified as handling the fake pills.

"We're suing to get the product off the market and to identify the source," said Pfizer spokeswoman Vanessa McGowan.

Both Med-Pro and Albers denied involvement.

"Med-Pro acted at all times in good faith and was never knowingly involved in counterfeit Lipitor," said company attorney J.R. Hobbs.

Albers attorney Kathy Dean said the fake pills never came to the distributor's warehouse but were directly shipped from Med-Pro to a small number of wholesalers.

"We are cooperating fully with the FDA and are willing to work with Pfizer to identify the true source of the counterfeit product," she said.

Counterfeit medicine is increasingly turning up in the United States. In the last year, the FDA has investigated more than half a dozen cases. Just last month, three men were charged in Miami with a counterfeiting scheme that sold bacteria-tainted water in the guise of the anti-anemia medicine Procrit.

[FairOpinion]

Earlier they found 3-4 lots, now apparently many more. I don't take it, but happened to have a doctor's visit today and I asked my doctor, whether the fake pills have been manufactured elsewhere, i.e. patent infringement and still contained the right ingredient, or whether they were just placebos.

He said the pills contain NO medication whatsoever. I would suggest that those who depend on Lipitor to keep their cholesterol down should check with your pharmacist and if you are in "high risk" category, even get a blood test to check your cholesterol is to make sure you have been taking real Lipitor, especially if your pharmacist has been getting them from Medpro. If it's up from where it should be, maybe you need a new batch. As new lots are discovered, anyone could be taking fake Lipitor, without knowing it.

PS. I hope the Admin Moderator will leave this in Breaking News,it could be very important for people taking Lipitor and it actually was in "Breaking News" in the source paper.

[FairOpinion]

Here is the alert from the FDA website:

http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01227.html

June 3, 2003
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA's Continuing Investigation Implicates Additional Lots
of Counterfeit Lipitor
The Food and Drug Administration (FDA) today announced that its continuing investigation of counterfeit Lipitor has turned up additional counterfeit quantities of the cholesterol-lowering pharmaceutical product. Two additional lots of 10 mg tablets in 90-tablet bottles, coded 20842V and 16092V, and one lot of 20 mg tablets in 90-tablet bottles, coded D270481, are involved. The labeling on each of these bottles states, “Repackaged by: MED-PRO, INC., Lexington, NE 68850.”

Since learning of problems with this product late last month, FDA investigators have aggressively pursued a variety of leads all along the supply and distribution chain. Evidence of the new lots of implicated Lipitor arose in the context of FDA’s investigation.

FDA’s advice to healthcare providers and consumers remains the same as when the agency issued its original alert on counterfeit Lipitor May 23, 2003. They should check the packaging very carefully before using Lipitor. Patients who have any of the product (labeled as “Repackaged by: MED-PRO, INC. Lexington, NE 68850”) with any of the following lot numbers should not take it, and they should return the product to their pharmacies:

20722V – 90-tablet bottles, 10 mg., Expiration 09-2004
04132V – 90-tablet bottles, 10 mg., Expiration 01-2004
16942V – 90-tablet bottles, 10 mg., Expiration 09-2004
20842V – 90-tablet bottles, 10 mg., Expiration 09-2004
16092V – 90-tablet bottles, 10 mg., Expiration 07-2004
D270481 – 90 tablet bottles, 20 mg.,Expiration not available.
FDA is working closely with the individual states and with health professionals, especially with pharmacists and pharmacy associations, to alert them to this counterfeit product. Many patients taking Lipitor do not receive it in the 90-tablet bottles being recalled, but in smaller quantities from their pharmacists. Patients who are not sure whether they have the implicated product should check with their pharmacist.

FDA is also working closely with the manufacturer of Lipitor, Pfizer, Inc., on this counterfeiting problem. FDA supports the activities of legitimate manufacturers to inform the public about counterfeit products and how to identify them. Last month, FDA entered into an agreement with a major pharmaceutical trade association to cooperate more closely on cases of suspected counterfeit products.

FDA’s investigation into this matter is continuing.

[lelio]

Just so I can get this straight the chain of getting the drug to your home is:
1 Pfizer (or someone else with a plant) makes the drug
2 Its shipped to Med-Pro in large lots, they put it in smaller bottles
3 Albers then ships it from there to your local pharmacist
4 You go to him and pick up the drugs

[bluefish]

Counterfeiting medication should be punishable by death. It is the ultimate greed, and is morrally on par with shooting a bank teller while holding up a bank, just for the hell of it.

I recall a pharmacist in CA here that was caught diluting a drug. I can't recall what the drug was for but I seem to recall it was something for a much more serious or urgent medical problem than high cholesterol levels.

[FairOpinion]

Does all of Pfizer's Lipitor goes to Med-Pro. I thought some does and some goes through other distributors, but I could be wrong, that was just my impression.

[lelio]

You're right, Med-Pro (and Albers) is just one of the players involved in each stage.
I just find it interesting that there's all these middlemen involved. Why doesn't Pfizer just ship it directly to your local drug store, or a distributor there?

[FairOpinion]

"I recall a pharmacist in CA here that was caught diluting a drug. I can't recall what the drug was"
--

It was a cancer drug and you are right, those people really didn't have much time.

While lack of cholesterol drug may not kill instantly, but people may have been taking fake Lipitor for months, or even longer, thinking their cholesterol is under control, and they could have a heart attack, because it isn't under control.

Also note at the end of the article they mention that there are other drugs that may be counterfeited, and how many they don't even know about?

[bluefish]

Ah yes.. Cancer. Thanks. For some reason, that story just irks me to no end. I think it is the extreme callousness. The crime is worse than stealing, counterfeiting Levis, or commiting some type of fraud.

It is comparable to murder, plain and simple. The callous disregard for the life of another required to do that, in order to make a buck, is beyond my comprehension.

Serial murderers you can write off as just nuts. A bank robber who shoots a security guard may have had every intention not to shoot somebody when he started his stupid criminal plan. The drug counterfeiter engaged in the activity with knowledge that he was not just taking money, but that he was killing people. Perhaps it would be more appropriate to compare these people with hitmen, or a kidnapper that kills his victim after collecting the ransom, to reduce his chances of getting caught.

[nutmeg]

bump

[Kerberos]

"Why doesn't Pfizer just ship it directly to your local drug store, or a distributor there?"

I believe this chain of resellers is to deal with the smaller drug store operations. I checked with my drug store, as I take Lipitor, and they informed me that they do not buy from any resellers, but buy direct from the manufacture and ship to their warehouse. However, they are a large chain operation and have enough buying power that they can deal directly with Pfizer.

[NotJustAnotherPrettyFace]

I just e-mailed this story to my father-in-law who takes Lipitor to be sure that he checks out his own supply with the pharmacist. Thanks for posting this heads-up!

[NotJustAnotherPrettyFace]

Why doesn't Pfizer just ship it directly to your local drug store, or a distributor there?

No fooling. That would help keep prices down.

[Dianna]

My husband just refilled his Lipitor. I called the pharmacy and the guy on the phone told me, "We don't carry the brand that was counterfeited."

Lord save me from stupid people. If he doesn't understand what I'm talking about how can I trust anything he says? I specifically asked him if they receive their Lipitor repackaged from Med-Pro and he said no. Shrug.

[Brad’s Gramma]

bttt