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Fake Drugs FAQ

Consumers have lots of choices for buying prescription drugs these days. But as you search for the best price or most convenience, be careful about the source of your medications. Counterfeit drugs are on the rise. Getting fooled by one could mean throwing your money away on ineffective drugs, or even worse, getting sick by taking drugs that aren’t what they pretend to be. The government and companies that manufacture and distribute drugs are working to keep counterfeit drugs out of the U.S. supply, but you can also play a role in making sure your drugs are what they’re supposed to be. These commonly asked questions about counterfeit drugs are a good start. You can also see our tips about avoiding fake drugs and buying prescriptions online.

What are counterfeit drugs? 

Counterfeit drugs are not what they say they are. Counterfeit drugs may not have the same active ingredients as the real thing, or they may contain the wrong active ingredients, not enough of the active ingredients, too much of the active ingredients, or no active ingredients at all. Counterfeit drugs may be falsely sold under brand names. Since the packaging may not provide truthful information about the ingredients or who made the drug, you can’t be certain what you’re getting.

Are counterfeit drugs really dangerous?

They can be. If you take counterfeit drugs, you are at risk for serious health problems, including unexplained side effects or allergic reactions. And your health could worsen if the “drug” you’re taking is ineffective.

For example, Procrit, a drug used by cancer and AIDS patients to fight fatigue and anemia, was counterfeited in 2002. Counterfeiters watered-down the medicine with non-sterile tap water to one-twentieth of the strength listed on the label. The tap water posed a risk of infection in already weak patients. Another recently counterfeited drug was Epogen, a drug used to treat severe anemia. Counterfeiters also watered-down this medication and reduced its effectiveness in patients’ bodies. These watered-down medications failed to help those patients when they needed them most. And in the summer of 2003, nearly 200,000 tablets of the cholesterol reducing medication Lipitor were found to be fake and recalled.

Are counterfeit drugs a big problem in the United States?

While U.S. drug supplies are generally considered safe, incidents of counterfeit drugs have been increasing. In the 1990s, the Food and Drug Administration (FDA) investigated an average of 5 cases a year; there have been more than 20 investigations per year since 2000. Counterfeiters are becoming more sophisticated in their technologies and methods of introducing counterfeit drugs into the US system.

Why the increase in counterfeit drugs in the US? 

There are several reasons for the increase. On the one hand, there is a higher demand for prescription drugs, as more are invented to treat disease. Some drugs are getting more expensive, so consumers may be more willing to turn to nontraditional sources. New technologies make it easier for criminals to make counterfeit drugs. And now that drugs are being sold over the Internet, without face-to-face contact between buyer and seller, it’s harder for consumers to know if the seller they’re dealing with is legitimate.

How do counterfeiters operate? 

Prescription drugs often follow a long path, through wholesalers and re-packagers, before reaching the pharmacy shelf. Although most drug wholesalers are not criminals, some are, and they sneak counterfeit drugs into the system. When wholesalers or re-packagers get their drug products from sources other than original manufactures, this creates the greatest opportunity for counterfeiting. For example, when low-priced drugs that are supposed to only be used by health clinics or Medicaid programs end up being taken from those places and sold again for a higher price. Once outside the regular distribution system, the drugs are no longer protected by the safeguards for re-packaging, content, and storage.

Because criminals can introduce counterfeit drugs at any stage in the drug distribution system, the FDA urges everyone in the drug distribution chain to help detect and stop the spread of counterfeit drugs.

How can I tell if my drugs are counterfeit? 

The best way for consumers to identify potential counterfeits is to be as familiar as possible with the drugs they regularly take. It’s difficult to tell just by looking at them, but the more familiar you are with both the packaging and the drugs themselves, the better the chances are that you’ll detect a fake drug before taking it. If you know the size shape, color, and taste of the medications you take, you will more easily identify possible counterfeits. When something doesn’t look or taste quite right, be suspicious. Check for altered or unsealed containers, or changes in the packaging or label. You might also be able to tell if a drug doesn’t have the effect that it promises, has different side effects than described, or doesn’t work in the same way as it did when you took it previously. You can reduce the risk of getting counterfeit drugs by buying from reputable pharmacies, but even they sometimes offer counterfeit drugs for sale without realizing it.

What is the FDA doing about this problem?

The FDA is currently working with companies that make and sell drugs to identify and prevent counterfeit drugs. A report issued by the FDA in February 2004 describes steps that can be taken to secure the U.S. drug distribution system. They include: strengthening laws to license and regulate drug wholesalers and distributors, adopting safe business practices by all players in the drug distribution chain, implementing new technologies to prevent counterfeiting, developing a system for reporting counterfeit drugs to the FDA quickly, working with governments and businesses in foreign countries, and educating consumers and health professionals about the risks of counterfeit drugs and how to report and respond. View the FDA’s report on counterfeit medicine.

How does the FDA learn about counterfeit drugs? 

While manufacturers, wholesalers, re-packagers, and pharmacists are in the best position to detect counterfeit drugs, they’re not currently required by law to report their suspicions to the government. But the FDA is developing a new reporting system, and the pharmaceutical industry recently announced a voluntary reporting program where companies agree to notify the FDA within five days of suspecting a drug has been counterfeited. The FDA also hears about counterfeit drugs from consumers and health care professionals.

Furthermore, the FDA has created a new alert network to provide information about counterfeit drug cases to various consumer groups and health professional organizations.

How can I report suspected counterfeit drugs?

You should report suspected counterfeit drugs to the pharmacist who sold you the medication and to your doctor if you are experiencing any medical problems. Your pharmacist will know whether there has been a legitimate change in the color, shape, taste, or packaging of the medication, and how to report your concern to the FDA. You can also report your suspicions directly to the FDA by calling the Medwatch program at 1-800-332-1088.

What are the new ways to stop the drug counterfeiters?

There are several technologies that could help stop counterfeiter in the United States. For example, radio frequency identification uses tiny electromagnetic devices placed in drug packaging to track products as they move through the distribution system. Other anti-counterfeiting technologies include tamper-proof packaging, special watermarks, and holograms that would be difficult for criminals to copy.

If I purchase drugs over the Internet, should I be concerned about counterfeits?

Legitimate drugs are sold in many ways, including the Internet, and so are counterfeit drugs. While purchasing drugs from online sellers can be convenient and economical, there are illegal Web sites that may sell you a contaminated or counterfeit product or a product that has not been approved by the FDA, deliver the wrong product, or take your money and never deliver anything in return. You can reduce the likelihood of trouble by dealing with legitimate, licensed online pharmacies.

Even if they sell legitimate drugs, some Web sites get around procedures set up to protect consumers. For example, some sites don’t require a prescription and only ask customers to fill out a questionnaire before getting a prescription drug, bypassing a face-to-face meeting with a health care professional. A 52 year-old man died of a heart attack in March 1999 after buying the impotence drug Viagra from an online source that required only answers to a questionnaire to get a prescription. A traditional doctor-patient relationship, along with a physical exam, could have uncovered the man’s family history of heart disease, and the risks associated with taking the Viagra. His death may have been avoided if he’d gone to his doctor to get a prescription drug.

How are online drug sellers regulated?

Pharmacies are regulated by state laws. They must be licensed in the states in which their headquarters are physically located. In addition, most states also require licenses for out–of-state pharmacies that ship medications to their residents. Federal agencies, such as the FDA and the Drug Enforcement Administration (DEA) also regulate the sale of drugs.

How can I learn more about counterfeit drugs and shopping for drugs safely?

The National Consumers League has tips for avoiding counterfeit drugs and advice about buying drugs online safely. The FDA also has information about counterfeit drugs and tips about buying drugs online.