FDA cracks down on illegal online pharmacies
Operation Pangea VI largest Internet-based action of its kind
FDA has taken action against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines, according to a June 27 FDA news release, including the seizure of 1,677 websites and more than $41 million worth of illegal medicines worldwide.
Many of these websites appeared to be operating as part of an organized criminal network that falsely claimed its websites were Canadian pharmacies, according to FDA. The websites displayed fake licenses and certifications to convince U.S. patients to purchase drugs they advertised as “brand name” and “FDA approved,” but the drugs were not from Canada and were neither brand name nor FDA approved. The websites also used certain major U.S. pharmacy retailer names to trick U.S. patients into believing an affiliation existed with these retailers.
In addition, the websites bypassed existing safety controls required by FDA and the protections provided when patients obtain medications with a valid prescription and under a doctor’s supervision, including products bought online.
During Operation Pangea VI, part of the sixth annual International Internet Week of Action, FDA partnered with law enforcement, customs, and regulatory authorities from 99 countries to identify the makers and distributors of illegal drug products and medical devices and remove the products from the supply chain. According to FDA, it was the largest Internet-based action of its kind.
Preliminary findings of screened drug products received through selected international mail facilities showed that certain medications from abroad, such as antidepressants, hormone replacement therapies, sleep aids, and other drugs to treat erectile dysfunction (ED), high cholesterol, and seizures, were on the way to U.S. patients.
Potentially dangerous medications
Some of the medicines sold illegally by the websites included the following:
- FDA-approved glimepiride and rosiglitazone (Avandaryl—GlaxoSmithKline), used to treat type 2 diabetes and to minimize potential associated risks, including edema caused by fluid retention, worsening the condition of the heart, or heart failure. The drug must be prescribed by a certified health care provider and dispensed by a certified pharmacy with a Medication Guide explaining the potential risks.
- “Generic Celebrex,” which sold online is not an FDA-approved product. FDA-approved celecoxib (Celebrex—Pfizer), a nonsteroidal anti-inflammatory product indicated for osteoarthritis and rheumatoid arthritis, must be dispensed with a Medication Guide explaining the potential associated risks with long-term use, including gastrointestinal bleeding, heart attack, or stroke.
- “Levitra Super Force” and “Viagra Super Force,” which are not FDA-approved products and claim to contain dapoxetine, a drug for which FDA has not determined the safety or efficacy. Vardenafil (Levitra—Bayer, GlaxoSmithKline) and sildenafil (Viagra—Pfizer) are FDA-approved medicines used to treat ED. Men with certain heart conditions should not take ED medicines containing vardenafil or sildenafil. Potentially dangerous drug interactions or serious adverse effects may occur with these drugs, such as loss of hearing or vision.
- FDA-approved clozapine (Clozaril—Novartis), used to treat severe schizophrenia. The drug is associated with potentially fatal agranulocytosis, a severely low white blood cell count that can predispose patients to serious, life-threatening infections. To minimize potential risks, FDA requires patients prescribed clozapine to enroll in a registry that ensures regular monitoring of their blood counts.
Identifying illegal online pharmacies
FDA’s Office of Criminal Investigations (OCI) Cybercrime Investigations Unit banner is now displayed on seized websites to help patients identify the sites as illegal. A list of the online pharmacies selling drugs illegally is available on FDA’s website. In addition, FDA offers information on how to identify an illegal pharmacy website and advice on how to find a safe online pharmacy through the BeSafeRx: Know Your Online Pharmacy campaign.
Many of these online pharmacies also pose non-health–related risks, including credit card fraud, identity theft, or computer viruses, FDA warned. Individuals can report suspected criminal activity directly to OCI.