Christina Spicer  |  October 22, 2020

Category: Drugs

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A doctor examining a woman's arm regarding the Picato cancer risks class action lawsuit

A man from British Columbia says the prescription medication Picato carried the risk of cancer; however, he and other Canadians were not warned of the potential side effect.

Lead plaintiff, Gerald Stewart, claims in his proposed Picato class action lawsuit that the drug maker, Leo Pharma, knew of the cancer risks after it tried to sell the drug in Europe starting in 2012. European regulators allegedly required Picato, also known as Ingenol mebutate, to be marketed with a warning about the potential development of skin tumors and squamous cell carcinoma.

“The potential for Picato to induce skin tumours was considered during Picato’s initial marketing authorization in the EU,” explains the complaint, “and the risk of AK progression to squamous cell carcinoma was reflected in Picato’s EU risk management plan as an important potential risk.”

Canadians Allegedly Not Informed of Picato Cancer Risk

Steward alleges that he and other Canadians who took the pharmaceutical were not informed of the risk of cancer associated with the drug.

“Since 2013, Ingenol mebutate has been marketed in Canada under the Picato brand name,” notes the proposed Picato class action lawsuit. “No such information relating to the risk of AK progression to squamous cell carcinoma were made on Picato products marketed and sold in Canada.”

In fact, according to the plaintiff, European regulators updated the warning on the drug to include an excess of skin tumors; however, Leo Pharma neglected to update warnings provided in Canada. Ultimately, in 2020, the drug was removed from the European market and subject to additional scrutiny in Canada.

The plaintiff alleges that the drug maker knew of Picato’s link to cancer years prior, but refused to warn Canadian consumers. Indeed, Steward says that he began using the drug in 2019, just before it was removed from the European market. He says that he would not have used Picato had he known of its link to skin cancer.

Picato Allegedly Treats Skin Condition

According to the drug’s website, Picato is a prescription gel used to treat actinic keratosis or AK. AK is a skin condition that results from years of sun exposure. According to the Mayo Clinic, the condition manifests as a rough scaly patch on the skin, usually on the face, ears, hands, forearms, neck, or scalp. Mayo Clinic notes that a small percentage of AK patches can turn into cancer.

The drug is meant to be used topically on the body, arms, or legs. Listed side effects include:

  • Allergic reactions, including swelling and chest tightness
  • Severe eye problems if it gets into the eyes
  • Mild skin reactions, such as redness, flaking, scaling, or swelling
  • Severe skin reactions, including Stevens-Johnson Syndrome

Picato’s website indicates the most common side effects are local, mild skin reactions. The drugmaker recommends contacting a healthcare provider about any bothersome side effects.

Picato No Longer Allowed in Europe

Recalled stamp regarding the Picato skin cancer class action lawsuit According to the Picato cancer risks class action lawsuit, in early 2020, European regulators recalled and removed the drug from the market over concerns about cancer. Allegedly, European regulators determined that the risks of the drug outweighed the benefits.

“After 3 years, 6.3% of patients treated with Picato (15 out of 240 patients) developed skin cancer, particularly squamous cell carcinoma,” stated the final report, according to the Picato cancer risks class action lawsuit. “In the treated skin area compared with 2% of patients treated with imiquimod (5 out of 244 patients).”

“Picato, a gel used on the skin to treat actinic keratosis, may increase the risk of skin cancer,” the report allegedly warned.

In July of 2020, Health Canada began its own review that concluded an increased risk of skin cancer in patients that used Picato. According to the class action lawsuit, Health Canada concluded that there was a link between the drug and skin cancer.

Lack of Warning Increased Risks of Cancer for Canadians

“The Plaintiff would not have used Picato had he been informed its use posed an increased risk of developing skin cancer and had he been provided accurate information and/or warning,” asserts the complaint.

The proposed Picato cancer risks class action lawsuit seeks to represent other Canadian residents who were prescribed and used Picato. The plaintiff accuses Leo Pharma of the tort of battery and personal injury. Stewart is seeking damages, including the costs of purchasing the drug, as well as costs associated with increased medical tests and monitoring for skin cancer.

Have you used Picato? Are you concerned about the class action lawsuit claim that the drug increases cancer risks? We want to hear from you! Tell us your thoughts in the comment section below.

The lead plaintiff and proposed Class Members are represented by Jesse R. Kendall of Rice Harbut Elliot LLP.

The Picato Cancer Risks Class Action Lawsuit is Stewart v. Leo Pharma Inc., et al., Case No S2010053, in the Supreme Court of British Columbia, Canada.

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One thought on Picato May Increase the Risk of Skin Cancer, Class Action Lawsuit Asserts

  1. Terry Dance-Bennink says:

    My dermatologist prescribed Picato for my sun-damaged face on October 7, 2020. I have just used two of the three tubes and my face is sore and looks terrible. My pharmacist at Shoppers Drug Mart, just called to tell me to stop use immediately and bring the remaining tube back to the store. I’ve just read your article and am most upset. I wish to be included in your class action. I’ve had breast cancer and this is most alarming. My dermatologist, Dr. Hamilton, also prescribed Picato for me several years ago, but fortunately I did not use it. What are my options now? I’ve booked an appointment with my dermatologist for tomorrow.

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