Counterfeit Drugs: Questions & Answers on Fake Medicines
Medically reviewed on Aug 9, 2018 by L. Anderson, PharmD.
What Are Counterfeit Drugs?
Simply put, counterfeit drugs are fake medicines. They are fraudulently produced or mislabeled medicines purchased by consumers who believe them to be legitimate treatments.
These drugs can cause a range of serious health concerns. Fake pills may look nearly identical to their genuine counterparts, but may be incorrectly formulated so that:
- they have the wrong amount of active ingredient (or none at all)
- may be labeled incorrectly
- contain a dangerous unapproved drug
- produced in substandard conditions.
An estimated 80% of counterfeit drugs come from overseas, and many are manufactured in India, Mexico and China.
Deadly Fentanyl Deception
Ongoing reports from The Partnership for Safey Medicines notes that the DEA considers fentanyl-containing counterfeit medications a global threat, and news releases highlight ongoing counterfeit production of these medications.
Fentanyl is an opioid 25 to 40 times stronger than heroin and used for chronic, severe pain, often in terminally ill cancer patients. Common brand names of fentanyl include Duragesic, Actiq, and Fentora.
Counterfeit fentanyl pills are showing up on the streets around the country. Their use can be deadly. DO NOT buy any drugs from street dealers or from online dealers; you have no idea what might be in the pill.
In 2018, the Department of Justice (DOJ) indicted two men in northern California who distributed counterfeit oxycodone pills made with fentanyl that lead to overdoses.
At least 2 dozen reports surfaced from Tennessee that fentanyl was being disguised as less powerful pain drugs like oxycodone or Percocet and sold on the streets in the U.S.
In California, several overdoses were caused by tablets that were labeled as "Xanax" but contained fentanyl, and lethal Norco -- bought off the streets -- has also been found to contain fentanyl.
In Cleveland, a man was arrested with more than 900 fentanyl pills marked as oxycodone.
Fentanyl Leads to Prince's Death
Fentanyl is inexpensive to make illegally, so dealers can make a bigger profit on the streets by disguising it as the higher priced oxycodone.
In fact, a letter published in the Journal of the American Medical Association (JAMA) in May of 2018 concluded that nearly half of opioid-related deaths in 2016 involved fentanyl. Fentanyl powder is cheap and easy to obtain from illicit web sites experts warn, and can easily be "cut" into other drugs. Ultimately, most people die from a fentanyl overdose because they stop breathing.
These counterfeit pills are often so expertly disquised even a forensic specialist cannot tell the difference visually. However, even touching or accidentally inhaling fentanyl is enough to cause an overdose, as has happened with some law enforcement officials and first responders.
One high-profile death was famed pop star Prince, who died in April 2016 due to a fentanyl overdose. Although it's not known if Prince died from counterfeit drugs, authorities say that hydrocodone pills found in his home labeled as hydrocodone did contain fentanyl.
Other controlled substances sold on the street that may contain fentanyl include U-47700, alprazolam (Xanax), heroin, ketamine, and cocaine.
Cashing In On Cancer
Fueled by easy internet sales, global supply routes, and minimal punishments, counterfeit prescription drugs have become an exploding industry worth over $75 billion a year worldwide. Counterfeit pharmaceuticals is big business, and not always steered by narcotics.
Cancer medicines are often targeted because they return big profits, are a fast growing segment, and patients are often desperate.
- A counterfeit version of the cancer drug BiCNU (carmustine for injection) has been found in some foreign countries, as warned by the FDA. The legitimate product is approved for treatment of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s).
- FDA also warned doctors that a phony version of Avastin for cancer called Altuzan contained no active ingredient and was being distributed in the U.S.
- The only way to ensure you are getting safe prescription drugs is to buy them from a licensed U.S. pharmacy selling FDA-approved products, or drugs you might receive that your medical doctor prescribed as part of a treatment regimen (such as with chemotherapy).
Which Drugs are Targeted?
What are the most common drugs that are involved in counterfeit transactions?
- Erectile dysfunction drugs such as Pfizer’s Viagra (sildenafil) (widely counterfeited) and Eli Lilly's Cialis (tadalafil)
- Xanax (alprazolam) and Ativan (lorazepam) used for anxiety
- Pain drugs Percocet (acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone) are also commonly counterfeited.
- Generic antibiotics, tuberculosis drugs, AIDS and malaria medicines are also targeted; infectious diseases are rampant in the developing world where there is little regulatory control, and these drugs are often acquired in desperation.
- Antipsychotics Zyprexa and Risperdal
- Antidepressant Zoloft
- Lipitor, a blockbuster cholesterol lowering medicine
- The counterfeit ADHD drug Adderall, previously in high demand because of a shortage, arrived in the U.S. through rogue Internet pharmacies.
Dangerous and Deadly Consequences
Why are counterfeit drugs so dangerous? Counterfeit drugs may contain the wrong amount of active ingredient -- or no active ingredient at all. Poisonous ingredients have been found in counterfeit medicines, as well. The risk to the user is significant.
Typical inactive ingredients added to counterfeit medicines include chalk, gypsum, acetaminophen, flour, talcum powder and sugar.
Of course, any ingredient, including other potent pharmaceuticals or dangerous chemicals or designer drugs concocted in an illegal lab can be added, too.
And what if the amounts are not exactly calculated? For example,
- the amount of active ingredient is too high
- if the dose is too low, treatment failure can occur
- possibly even death due to excessive or inadequate amounts of a product.
As an example, the World Health Organization (WHO) estimates that 100,000 Africans die each year as the result of fake anti-malarial drugs.
How Can I Protect Myself From Counterfeits?
Counterfeit drugs can be sold through rogue Internet sites which pose as legitimate pharmacies, as well as on the streets.
These illegal online pharmacies look real, so follow these tips:
- If using an online pharmacy, make sure it has a legitimate U.S. street address, phone number, and pharmacist.
- Check with the National Association of Boards of Pharmacy, which maintains a list of accredited online pharmacies.
- Don’t buy drugs from sites that sell meds without a prescription.
- For more information on buying a medicine on the internet, go to this FDA website.
Deceptive Online Diazepam (Valium)
Although the U.S. has a comprehensive system of laws and regulations to keep the incidence of drug counterfeiting low, in recent years the FDA has seen a growing and sophisticated network to expand counterfeit drug trafficking.
The FDA also warned consumers about counterfeit diazepam (Valium) being sold on the Internet.
The World Health Organization (WHO) has previously reported 700 adverse events from patients in Central Africa taking what they thought was diazepam (brand name Valium), but was actually the antipsychotic drug, haloperidol (Haldol). The patients who mistakenly took haloperidol suffered acute contractions of the muscles of the face, neck and tongue (dystonia).
In Scotland, as reported by the BBC in 2017, fake Valium pills containing etizolam, which mimics many of the effects of diazepam, were found on the black market, and can be fatal when combined with opioids such as heroin or methadone. They were linked with several deaths.
Get to Know Your Medicine
Any time you get a prescription refilled, check the color, texture, taste and shape of the medicine. If there is anything different, talk to your pharmacist.
If you are getting a prescription filled for the first time, or you have been given a medicine that looks different, try the Drugs.com Pill Identifier to check. It can match the imprint, size, shape, or color of your tablet and lead you to the detailed description in our drug database.
In any case where you suspect you may be in possession of a counterfeit medicine take it to your pharmacist for verification. Never take any medicine you suspect to be fraudulent or incorrect.
FDA Cracks Down: Operation Pangea
U.S. authorities are keenly aware of the ongoing online counterfeit and illegal importation problem in the U.S., and are making efforts to combat it.
In June, 2016, the U.S. Food and Drug Administration took action against over 4,400 websites that illegally sold potentially dangerous, unapproved prescription drugs to U.S. consumers. This effort was part of Operation Pangea IX to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the Internet.
Review of imported drug products showed that U.S. consumers had purchased certain unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other diseases.
How Else to Combat Counterfeits?
Pharmaceutical companies and the FDA dedicate resources to help contain the counterfeit problem.
Technologies such as:
- Radio Frequency Identification
- Holographic labels
- Infra-red inks
- Supply chain tracking, as described by the FDA
- Digital serial number identification
- Chemical fingerprints
are being employed as quality control and anti-counterfeiting measures.
Stronger legislation to ensure appropriate punishment and a global collaboration with foreign governments are important in order to deter counterfeiters.
Finally, as consumers, the best thing we can do is to educate ourselves about the medicines we take and purchase them responsibly from a verfied and legitimate pharmacy.
Finished: Counterfeit Drugs: Questions and Answers on Fake Medicines
- Jones CM, Einstein EB, Compton WM. Changes in Synthetic Opioid Involvement in Drug Overdose Deaths in the United States, 2010-2016. JAMA. 2018 May 1;319(17):1819-1821. Accessed August 9, 2018 at https://www.ncbi.nlm.nih.gov/pubmed/29715347
- The Partnership for Safe Medicines. Resources For Patients. Accessed August 9, 2018 at https://www.safemedicines.org/patient-resources
- Bernstein I. Keeping the U.S. Prescription Drug Supply Chain Among the Safest in the World. FDA Voice (Blog). July 20, 2017. Accessed August 9, 2018 at https://blogs.fda.gov/fdavoice/index.php/2017/07/keeping-the-u-s-prescription-drug-supply-chain-among-the-safest-in-the-world/
- Potentially Deadly Painkiller Being Disguised as Less Powerful Drugs. Drugs.com. March 2016. https://www.drugs.com/news/potentially-deadly-painkiller-being-disguised-less-powerful-60325.html
- Counterfeit pills found at Prince's home contain powerful opioid fentanyl. The Guardian. August 21, 2016. Accessed August 9, 2018 at https://www.theguardian.com/music/2016/aug/21/prince-death-cause-fentanyl-opioid-counterfeit-pills-drug-overdose
- Counterfeit Medicine. US Food and Drug Administration (FDA). Accessed August 9, 2018 at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/
- Fentanyl-Laced 'Norco' Is Lethal, Report Warns. Drugs.com. 7/29/2016. Accessed August 9, 2018 at https://www.drugs.com/news/fentanyl-laced-norco-lethal-report-warns-62152.html
- Illegal Online Meds Targeted in Worldwide Crackdown, FDA Says. Drugs.com. May 22, 2014. Accessed August 9, 2018 at https://www.drugs.com/news/illegal-online-meds-targeted-worldwide-crackdown-fda-says-51716.html
- Fake valium 'cheaper than chips', warns drug expert. BBC News. Jan 13, 2017. Accessed August 9, 2018 at https://www.bbc.com/news/uk-scotland-38610142