Saturday, February 5, 2011

Warning Counterfeit Medicine: Ambien, Xanax, Lexapro, and Ativan





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The Food and Drug Administration (FDA) wants to warn consumers about the possible dangers of buying medicines over the Internet. Some websites sell prescription and over-the-counter drugs that may not be safe to use and could put people's health at risk.

So how can you protect yourself?

FDA says that consumers should know how to recognize a legal Internet pharmacy and how to buy medicines online safely.

Don't Be Deceived
Buying prescription and over-the-counter drugs on the Internet from a company you don't know means you may not know exactly what you're getting.

There are many websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines. But there are also many “rogue websites” that offer to sell potentially dangerous drugs that have not been checked for safety or effectiveness. Though a rogue site may look professional and legitimate, it could actually be an illegal operation.

These rogue sites often sell unapproved drugs, drugs that contain the wrong active ingredient, drugs that may contain too much or too little of the active ingredient, or drugs that contain dangerous ingredients.
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For example, FDA purchased and analyzed several products that were represented online as Tamiflu (oseltamivir). One of the orders, which arrived in an unmarked envelope with a postmark from India, consisted of unlabeled, white tablets. When analyzed by FDA, the tablets were found to contain talc and acetaminophen, but none of the active ingredient oseltamivir.

FDA also became aware of a number of people who placed orders over the Internet for one of the following products:

Ambien (zolpidem tartrate)
Xanax (alprazolam)
Lexapro (escitalopram oxalate)
Ativan (lorazepam)

Instead of receiving the drug they ordered, several customers received products containing what was identified as foreign versions of Haldol (haloperidol), a powerful anti-psychotic drug. As a result, these customers needed emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms, and muscle stiffness—all problems that can occur with haloperidol.

Other websites sell counterfeit drugs that may look exactly like real FDA-approved medicines, but their quality and safety are unknown.

Signs of a trustworthy website

It's located in the United States.
It's licensed by the state board of pharmacy where the website is operating. A list of these boards is available at the website of the National Association of Boards of Pharmacy
It has a licensed pharmacist available to answer your questions.
It requires a prescription for prescription medicines from your doctor or another health care professional who is licensed to prescribe medicines.
It provides contact information and allows you to talk to a person if you have problems or questions.
Another way to check on a website is to look for the National Association of Boards of Pharmacy's (NABP) Verified Internet Pharmacy Practice Sites™ Seal, also known as the VIPPS® Seal.

This seal means that the Internet pharmacy is safe to use because it has met state licensure requirements, as well as other NABP criteria. Visit the VIPPS website5 to find legitimate pharmacies that carry the VIPPS® seal.

Signs of an unsafe website

It sends you drugs with unknown quality or origin.
It gives you the wrong drug or another dangerous product for your illness.
It doesn't provide a way to contact the website by phone.
It offers prices that are dramatically lower than the competition.
It may offer to sell prescription drugs without a prescription—this is against the law!
It may not protect your personal information.
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Know Your Medicines
Before you get any new medicine for the first time, talk to a health care professional such as your doctor or pharmacist about any special steps you need to take to fill your prescription.

Any time you get a prescription refilled

check the physical appearance of the medicine (color, texture, shape, and packaging)
check to see if it smells and tastes the same when you use it
alert your pharmacist or whoever is providing treatment to anything that is different
Be aware that some drugs sold online

are too old, too strong, or too weak
aren't FDA-approved
aren't made using safe standards
aren't safe to use with other medicines or products
aren't labeled, stored, or shipped correctly
may be counterfeit
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Counterfeit Drugs
Counterfeit drugs are fake or copycat products that can be difficult to identify.

The deliberate and fraudulent practice of counterfeiting can apply to both brand name and generic products, where the identity of the source is often mislabeled in a way that suggests it is the authentic approved product.

Counterfeit drugs may

be contaminated
not help the condition or disease the medicine is intended to treat
lead to dangerous side effects
contain the wrong active ingredient
be made with the wrong amounts of ingredients
contain no active ingredients at all or contain too much of an active ingredient
be packaged in phony packaging that looks legitimate
For example, counterfeit versions of the FDA-approved weight loss drug Xenical, which contains the active ingredient orlistat, recently were obtained by three consumers from two different websites.

Laboratory analysis showed that the capsules that the consumers received contained the wrong active ingredient, sibutramine.

Sibutramine is the active ingredient of a different medicine called Meridia, a prescription drug also approved by FDA to help obese people lose weight and maintain weight loss. In addition, sibutramine is classified as a controlled substance by the Drug Enforcement Administration because of its potential for abuse and misuse.

Using medicine that contains an active ingredient that wasn't prescribed by your licensed health care provider may be harmful.

FDA continues to proactively protect consumers from counterfeit drugs. The agency is working with drug manufacturers, wholesalers, and retailers to identify and prevent counterfeit drugs. FDA also is exploring the use of modern technologies and other measures that will make it more difficult for counterfeit drugs to get mixed up with, or deliberately substituted for, safe and effective medicines.

For more information on this topic, visit FDA's FDA's Web page on Counterfeit Medicine

How to Protect Yourself

Only buy from state-licensed pharmacy websites located in the U.S.
Don't buy from websites that sell prescription drugs without a prescription.
Don't buy from websites that offer to prescribe a drug for the first time without a physical exam by your doctor or by answering an online questionnaire.

Check with your state board of pharmacy or the National Association of Boards of Pharmacy to see if an online pharmacy has a valid pharmacy license and meets state quality standards.
Look for privacy and security policies that are easy to find and easy to understand.
Don't give any personal information—such as a social security number, credit card information, or medical or health history—unless you are sure the website will keep your information safe and private.

Use legitimate websites that have a licensed pharmacist to answer your question.
Make sure that the website will not sell your personal information, unless you agree.
For information on protecting yourself against a whole range of bogus health products that includes counterfeit drugs, see FDA's Consumer Update, "FDA 101: Health Fraud Awareness."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Updated: January 26, 2011

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