A proposed class action seeks refunds for consumers who bought LEO Pharma’s now-discontinued Picato gel that’s been linked to an increased risk of squamous cell skin cancer.
The 15-page lawsuit claims that while LEO’s prescription Picato gel (ingenol mebutate) was designed to treat precancerous actinic keratosis, a condition typically seen in older adults as a crusty, scaly patch of skin caused by years of sun exposure, the product is, in truth, “worthless” given it may actually increase one’s risk of developing skin cancer.
According to the complaint in California’s Eastern District Court, Madison, New Jersey-based LEO Pharma permanently discontinued Picato in October 2020, months after the European Medicines Agency (EMA) suspended sales of the product while its Pharmacovigilance Risk Assessment Committee (PRAC) conducted a review. Per the lawsuit, the EMA’s January 2020 suspension announcement detailed “troubling results” from “several studies and clinical trials”:
The final results of a three-year study in 484 patients showed a higher incidence of skin malignancy with ingenol mebutate than with the comparator imiquimod (3.3% of patients developed cancer in the Picato group versus 0.4% in the comparator group).
A higher incidence of skin tumours occurred in the ingenol mebutate arm of an 8-week vehicle-controlled trial in 1,262 patients (1% of patients in the ingenol mebutate arm versus 0.1% in the vehicle arm).
In addition, in four clinical trials involving 1,234 patients with a related ester, ingenol disoxate, a higher incidence of skin tumours occurred with ingenol disoxate than with a vehicle control (7.7% versus 2.9% of patients, respectively). As ingenol disoxate is closely related to Picato, the results were considered relevant in the ongoing review of Picato.
The lawsuit says the PRAC concluded in an April 2020 report that Picato “may increase the risk of skin cancer,” and that “the risks of the medicine outweigh the benefits.” Moreover, the PRAC, the suit relays, added that “Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis.” Further, the case says, the EMA warned patients treated with Picato that they should be on the lookout for “unusual skin changes or growths, which could occur from weeks to months after use, and seek medical advice if any occur.”
Then, in July 2020, the lawsuit says, Health Canada, the country’s governmental department responsible for national health policy, issued a report that stated it had reviewed “29 case reports of skin cancer in patients treated with Picato,” and that 26 of the cases were found to be “possibly linked.” Health Canada also “assessed 12 studies published in scientific and medical literature in order to determine the link between Picato and skin cancer,” finding that six of the 12 studies “had evidence of skin cancer with use of Picato,” the lawsuit states.
Based on this evidence, Health Canada advised patients being treated with Picato to “stop their treatment” and contact a healthcare professional to discuss other options, the suit says. In October 2020, LEO Pharma, at Health Canada’s request, initiated a recall of Picato from the Canadian market, the case reads:
“Health Canada also advised patients to ‘monitor and immediately report to their healthcare professional any signs or symptoms of skin cancer, such as new scaly red patches on their skin, open sores, or elevated or warty growths within the treatment area, which could occur after stopping treatment.”
Per the suit, the plaintiff, a Sanger, California resident, was diagnosed around July 2018 with actinic keratosis and prescribed Picato, for which he paid an approximate $20 out-of-pocket copay. After using Picato, the plaintiff developed cancer in the area where he applied the gel, the lawsuit says. Upon buying the product, the man believed that Picato was safe, effective and properly designed and would not have bought the product had he known it was not free from defects, according to the complaint.
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