FDA blocks Australia site from importing tainted Cialis as Lilly claims innocence

12-Jan-2015 - Last updated on 12-Jan-2015 at 21:23 GMT

FDA files an import alert and Lilly cries foul

Related tags Lilly Pharmaceutical drug Eli lilly

The US FDA has published an import alert for an Australian manufacturing site of Eli Lilly after the agency found that its Cialis pills were tainted with the active ingredient of another popular ED (erectile dysfunction) drug -- Pfizer’s Viagra.

The only problem – Eli Lilly doesn’t have a manufacturing site in Australia.

“Sample analysis of the aforementioned product found the product to contain tadalafil and sildenafil,” FDA said in regards to product coming from the West Ryde, Australia-based manufacturing facility. “Although Cilias [sic] is currently an approved new drug product; the current application does not include the combination of tadalafil and sildenafil. As such; the aforementioned product appears to be an unapproved new drug.”

However, it seems the FDA was fooled by a counterfeiter as Lilly spokeswoman Celeste Stanley told InPharma-Technologist.com, “Lilly has contacted the FDA to learn more about this alert. Lilly does not manufacture Cialis in Australia. In fact, Lilly does not currently operate a manufacturing site in Australia for any of its products. Thus, any Cialis product with packaging stating it is from Lilly in Australia is not genuine.”

The spokesman also clarified that Lilly does not manufacture “any combined product with both tadalafil and sildenafil active ingredients. Therefore, based on information in this import alert, this appears to be a counterfeit version of Cialis that is also unapproved product as the FDA states in its alert.”

Crackdown on Counterfeits

The import alert and counterfeits from Australia come as Lilly decided in early 2014 to invest more than $100m (€75m) in order to meet the latest global counterfeiting regulations, including track-and-trace regulations from the US.

ED medications are among the most frequently counterfeited. The Pharmaceutical Security Institute reports that 37 percent of all fake medicines seized are ED drugs. What’s even more daunting is that 97 percent of online pharmacies are not certified and oftentimes do not offer legitimate products.

Counterfeit Cialis and Viagra tablets were among those found in the largest seizure of fake drugs in EU history.

“Counterfeit drugs may be toxic. Even if symptoms improve, those who take these fake drugs may also ingest chalk, talcum powder, road paint, shoe polish and dangerous heavy metals,” Stanley told us.

When Cialis was first marketed, the company used color-shifting blister packs to make the real versions of the product stand out from counterfeits.