Counterfeit Drugs

Stendra already counterfeited

Stendra is currently only available in a few countries, yet the internet is flooded with offers of “genuine” Stendra. These drugs are not what they say they are. They are fake! 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 to have an effect, too much of the active ingredients that can cause serious side effects or death, 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.  Viagra, Cialis and other have been battling counterfeit by drug rings for years.

It’s estimated that 90% of counterfeit drugs are sold on the Internet and that the global sale of counterfeit drugs will reach $75 billion this year. Counterfeit drug deaths include men who took fake erectile dysfunction drugs, pregnant women injected with fake iron for anemia and children who took paracetamol syrup contaminated with antifreeze.

Counterfeit version of drugs have made their way to pharmacies and hospitals in at least 46 countries, including England, Canada, and the U.S., according to John Clark, a former FBI agent who now heads drug maker Pfizer’s anticounterfeit team.

Are counterfeit drugs really dangerous?

Yes!  They can be. If you take counterfeit drugs, you are putting yourself 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.  Too much of the ingredient can lead to death.

These drugs are often made in dirty  warehouses with no quality control or oversight.  Some of Chinese labs have been found with fungus growing on the wall.  In Ecuador, boric acid was one of the pill ingredients.  In Montreal, commercial grade wall paint was used to give pills color.  In Columbia, pills were made using sheet rock and rat poison.  And in Hungary, they contained illegal street drugs such as Methamphetamine.  “If you’re taking a pill that has rat poison, lead, boric acid you could become potentially very ill from that, and possibly even have a fatal complication,” said urologist Jed Kaminetsky.

Fake  drugs alone are estimated to kill over a million people a year.

  • Nearly half the drugs sold in Angola, Burundi, and the Congo are substandard
  • About two thirds of artesunate (anti-malaria) drugs in Laos, Myanmar Cambodia and Vietnam contain insufficient active ingredient
  • Most fake drugs originate from China and India
Current attempts to deal with the problem through tougher regulation and criminal penalties do not address the root causes of counterfeiting. Worse, many countries have corrupt regulatory and legal systems that are easily exploited by criminal counterfeiters, so additional rules will only increase corruption.
“However, obstacles to effective action include the lack of a clear worldwide consensus on what constitutes a counterfeit drug and the fact that activities that are illegal in one country may be legal in another” says Dr Jackson.

“In some cases producing counterfeit medicine can be ten times as profitable per kilogram as heroin, yet in the UK someone can face greater legal sanctions if they produce a counterfeit T-shirt.

Are counterfeit drugs a big problem in the United States?

The maker of Viagra, Pfizer,  actually ordered their popular “little blue pill” from 26 online pharmacies, 81 percent of the pills turned out to be counterfeit.  While U.S. drug supplies from reputable sources are generally considered safe, incidents of counterfeit drugs have been increasing. In the 1990s, the U.S. Food and Drug Administration (FDA) investigated an average of 5 cases a year; there have been more than 20 investigations per year since 2000. In the past decade these have grown substantially.  Counterfeiters are becoming more sophisticated in their technologies and methods of introducing counterfeit drugs into the US system.

In 2010 agents nabbed about 330 shipments of fake ED drugs.  So far this year the number is already approaching five-times that amount.

“The drug market on the internet is the wild west”, says investigator, Mike Lopez.  “You have no idea what you are putting into your body, and there is not one to hold accountable if you get sick.  These companies come and go, changing names and locations.”

The FDA is also cracking down on banned or recalled ED drugs that could harm or kill consumers.

Fake pharmaceutical drugs – whether sold directly over the internet or infiltrated into the neighbourhood pharmacy or local hospitals – have become a huge and fast-increasing threat.  The problem is also very common in Europe.   In 2005, 500,000 single doses of fake medicines were discovered across Europe.  Counterfeit seizures in the European Union (EU) quadrupled between 2005 and 2007 and the number of drug fraud investigations carried out by the US Food and Drug Administration rose 800 per cent between 2000 and 2006.

Worldwide, according to figures collected by the pharmaceutical giant Eli Lilly, customs seized more than three million counterfeit or suspected counterfeit tablets in more than 1,000 separate actions in the last two years.  But the problem keeps increasing as consumers look for cheaper alternatives to established retail outlets.

Men who buy fake Internet drugs for erection problems can face significant risks from potentially hazardous contents and bypassing healthcare systems could leave associated problems like diabetes and high blood pressure undiagnosed. That’s the warning just published online by IJCP, theInternational Journal of Clinical Practice.

Investigators have found records showing that a Chinese drug company implicated in nearly 100 children’s deaths in Haiti also shipped about 50 tons of counterfeit drugs to the United States in 1995. Some of it was later resold to another American customer, Avatar Corporation, before the deception was discovered.

Why the increase in counterfeit drugs in the US?

The demand for  prescription drugs is growing fast.  More and more drugs are being invented to treat diseases. Some drugs are getting very expensive, so consumers may be more willing to turn to nontraditional sources such as the internet. New manufacturing technologies make it easier for criminals to make counterfeit drugs. Now that drugs are being sold over the Internet, consumers no longer have the face-to-face contact between with the seller, it’s harder for consumers to know if the seller they’re dealing with is legitimate.  And often imposible to find the seller if there is illness or death from the fake drugs.

How do counterfeiters operate?

Prescription drugs have a long supple chain from the manufacturer, through distributors, then wholesalers and re-packagers, before reaching the pharmacy or hospital shelf. Although most  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. The FDA’s report is at

In the latest erectile dysfunction drug bust to take place at Los Angeles International Airport, a 71-year-old was stopped by customs officials who discovered nearly 40,000 fake pills stuffed in his luggage and a golf bag.

On Wednesday, federal agents arrested Kil Jun Lee, an ex-law enforcement officer from South Korea, who tried to bring 29,827 fake Viagra pills, 8,993 fake Cialis pills and 793 Levitra look-alikes into the states on a flight from his native country.

Asked if he planned to use the drugs himself, Lee told officers he had a heart condition and would die if he took them all, according to the criminal complaint.

The pills, which were wrapped in aluminum foil, were valued at $700,000, Immigration and Customs Enforcement said in a statement.

The United States Food and Drug Administration has warned drug makers and suppliers in the United States “to be especially vigilant” in watching for these counterfeit drugs and drug ingredients.

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. In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products.  Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.

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.

Each time they say hundreds of thousands of pills shipped from overseas are confiscated — just a small fraction of what makes it through to those eager to buy them.

The FDA says that you should only buy from a registered pharmacy with a legitimate prescription from your doctor. And, like anything else, if the price or deal seems to be good to be true, it likely is!

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.

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