Drug Injury Watch

Picato Skin Cancer Risk Investigation By European Drug Regulator Prompts Sales Suspension In Europe

January 2020 News Report: FDA "is gathering data and information to investigate the safety concern related to Picato"

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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UPDATE: The UK's Medicines and Health products Regulatory Agency (MHRA) issued a class 2 medicines recall for Picato on January 27, 2020.

Class 2 Medicines Recall: LEO Laboratories Ltd, Picato 150 mcg/g gel ▼, EU/1/12/796/001, Picato 500 mcg/g gel ▼, EU/1/12/796/002 (EL (20)A/02)

This regulatory action comes after the earlier voluntary sales suspension of Picato by LEO Pharma.

(1/28/2020)

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The topical gel drug Picato (ingenol mebutate) is prescribed for the treatment of actinic keratosis, or solar keratosis, a skin condition that can become cancerous in some patients. However, the safety of Picato is currently under scrutiny, as the European Medicines Agency (EMA) is investigating whether the use of Picato increases skin cancer risks.

From this January 17, 2020 press release, "EMA suspends Picato as a precaution while review of skin cancer risk continues", we get this information about the safety of Picato:

EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.

EMA’s safety committee [Pharmacovigilance Risk Assessment Committee (PRAC)] is currently reviewing data on skin cancer in patients using Picato. Final results from a study comparing Picato with imiquimod (another medicine for actinic keratosis) indicate a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod.

While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer. The PRAC has therefore recommended suspending the medicine’s marketing authorisation as a precaution and noted that alternative treatments are available.

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The company that markets Picato, LEO Pharma, issued a January 7, 2020 statement which sets forth its position on this new Picato drug safety issue:

The voluntary withdrawal [of Picato] is not linked to any new incidents of adverse events, customer complaints or quality effects....

LEO Pharma has carefully reviewed the information received from PRAC, and the company disagrees with the ongoing assessment of PRAC. There is no additional safety data and it is LEO Pharma’s position that there is no evidence of a causal relationship or plausible mechanism hypothesis between the use of Picato® and the development of skin malignancies.

A Medscape news report, "European Marketing of Picato Suspended While Skin Cancer Risk Reviewed", published January 17, 2020 let us know about the status of Picato in the US as that point in time:

"This matter does not affect Picato in the U.S., and there are no new developments in the [United States]. Picato continues to be available to patients in the U.S. We remain in dialogue with the U.S. Food and Drug Administration about Picato in the EU/EEA," Rhonda Sciarra, associate director of global external communications for LEO Pharma, said in an email. "We remain committed to ensuring patient safety, rigorous pharmacovigilance monitoring, and transparency," she added.

The FDA "is gathering data and information to investigate the safety concern related to Picato," a spokesperson for the FDA told Dermatology News. "We are committed to sharing relevant findings when we have sufficient understanding of the situation and of what actions should be taken," he added.

We will continue to monitor the safety of Picato and report any further drug regulatory actions here.

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Acute Renal Failure With Uloric Reported Almost 6 Times More Frequently Compared To Some Other Gout Drugs

Uloric-Related Acute Kidney Injury: Researchers Find A Significantly Higher Reporting Odds Ratio In Women Compared To Men

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Uloric (febuxostat) is a popular urate-lowering therapy (ULT) used as a first-line treatment for gout, as is the generic drug allopurinol. According to a recent medical journal article, acute renal failure (ARF), or kidney failure, is reported as an adverse drug reaction 5.7 times more frequently with Uloric than with other ULT gout drugs, and 3.3 times more often with allopurinol. This is some important new Uloric drug safety information from our perspective.

This article, "Acute Kidney Injury Associated With Febuxostat and Allopurinol -- A Post-Marketing Study", was published by the Arthritis Research & Therapy medical journal in November 2019.  The new Uloric drug safety information presented by medical researchers in that article is summarized in this excerpt:

In the present study, we detected a disproportionality signal for [acute renal failure (ARF)] and the ULTs [Uloric (febuxostat)] and allopurinol. The presence of this signal was confirmed in a variety of sensitivity analyses (i.e., when [Uloric (febuxostat)] and allopurinol were the only suspected drugs, when we used other [Xanthine oxydase (XO)] inhibitors as the comparator or when known nephrotoxic drugs were excluded).

The purpose of studying the disproportionality of spontaneous [individual case safety reports (ICSRs)] is to generate pharmacovigilance alerts concerning unknown or underestimated [adverse drug reactions (ADRs)]. Until the present case/non-case study, the risk of [acute kidney injury (AKI)] associated with allopurinol and [Uloric (febuxostat)] had been underestimated. In fact, renal and urinary tract disorders were reported (albeit not in detail) during an extended phase III [Uloric (febuxostat)] clinical trial [12]. However, AKI has not been mentioned for other phase III trials. Moreover, to the best of our knowledge, no phase IV studies have addressed this topic for the two studied ULTs. [Footnotes omitted.]

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The November 2019 medical journal article goes on to point out why this new Uloric drug safety information may be more of a concern for women than men:

For both drugs, the [reporting odds ratio (ROR)] was higher in women than in men, respectively 11.60 [9.74–13.82] vs. 3.14 [2.69–3.67] for [Uloric (febuxostat)] and 4.45 [4.04–4.91] vs. 2.29 [2.11–2.50] for allopurinol.

We will continue to monitor the FDA and review medical journals for any significant developments concerning this new Uloric drug safety information about acute kidney injury (AKI) and acute renal failure (ARF).

Our law firm is investigating possible Uloric lawsuits where patients have suffered Uloric side effects.

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Belviq Cancer Risk Warning Alert Issued To Patients And Doctors In January 2020 FDA Drug Safety Communication

Recent Clinical Trial Findings Suggest Use Of The Weight-Loss Medicine Belviq Increased Risk Of Cancers

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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UPDATE:  "FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market"  (2-13-2020 FDA Drug Safety Communication)

"Potential risk of cancer outweighs the benefits"

• Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases.

 

(2/13/20)

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An FDA Belviq cancer warning alert, "Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer", was issued on January 14, 2020.  Belviq and Belviq XR are approved by FDA for use with a reduced-calorie diet and increased physical activity to help weight loss in adults who are obese or are overweight and have weight-related medical problems.

From that January 2020 FDA Belviq Drug Safety Communication we get the following:

ISSUE: The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and we cannot conclude that [Belviq] contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review.

This contextual information is provided by a related FDA document, "Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)":

When approving [Belviq], we required the drug manufacturer, Eisai Inc., to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems. In this trial, which was conducted in approximately 12,000 participants over 5 years, more patients taking [Belviq] were diagnosed with cancer compared to patients taking placebo, which is an inactive treatment. Our evaluation of this potential signal is ongoing, and at this time it is uncertain if [Belviq] increases the risk of cancer.

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A January 14, 2020 MedPage Today news report, "Diet Drug Possibly Linked to Cancer, FDA Says", present some background for the FDA Belviq cancer warning:

Some rat studies had suggested "mammary gland tumors in both sexes at clinically relevant exposures" and other tumor types in male rats at higher doses, according to an FDA review document [PDF, 425 pages] from 2012. But "[o]verall, malignancies were seen infrequently in the Phase 3 program. No formal cancer screening was conducted," it said, and the advisory committee "in general agreed that there is a sufficient safety margin for the drug when it is used at the concentrations intended for patients."

We will watch for any further FDA action as regards Belviq and report significant developments here.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Are Zantac NDMA Levels Increased By Heat Exposures During Shipping And Storage?

This Theory Would Explain Why NDMA Was Not Found To Be A Problem At Zantac Manufacturing Sites

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

The fact that Zantac contains NDMA (nitrosamine impurity called N-nitrosodimethylamine), a probable human carcinogen, was the subject of a September 13, 2019 FDA Press Announcement, "Statement alerting patients and health care professionals of NDMA found in samples of ranitidine".  Since then there has been uncertainty about how this Zantac NDMA problem went undetected for so many years. Ranitidine is the active ingredient in Zantac, which was initially approved by the FDA in 1983.

Several months later, there is a new theory about how that could have happened. From this January 2, 2020, Bloomberg news report, "Carcinogen in Heartburn Drug May Build in Storage, Lab Finds", we are presented with this possible scenario:

The heartburn medicine Zantac appears to produce unacceptably high levels of a cancer-causing chemical when exposed to heat for as little as five days, according to a testing laboratory....

New testing by an Alameda, California-based independent laboratory called Emery Pharma found that a combination of heat and time can raise levels of NDMA, potentially while drugs are sitting in packaging well after being analyzed by their manufacturers....

“The more you heat it, the more NDMA you generate,” Emery CEO Ron Najafi said in a telephone interview. “I am worried that if it just sits at home at room temperature, it could gradually generate NDMA.”

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That January 2020 news report, however, includes two points which may cause some people to view this new theory about the Zantac NDMA problem with some skepticism:

1.  Emery Pharma was hired by the pharmacy company Valisure LLC, which petitioned the FDA to recall all forms of Zantac; and,
2.  Emery CEO Najafi works as an expert witness in litigation alleging that Zantac contains NDMA.

So what comes next? The Bloomberg article provides this insight:

On [January 2, 2020], Emery filed a Citizen Petition with the FDA, asking the agency to suspend sales of all products containing ranitidine, to recall those that are already on the market and to require stability testing before they can be sold in the future. The medicine should also be shipped in temperature-controlled vehicles and carry warnings that potential cancer-causing byproducts may be produced if it is exposed to heat, the lab said.

As background, typically the FDA will review a filed Citizen Petition and eventually respond directly to the group that filed it.

So we will have to wait to see what the FDA thinks about this Zantac NDMA causation or mechanism of action theory developed by Emery Pharma.

Here is a related article we published previously: "Zantac FDA Warning In September 2019 Leads To Lawsuits For Patients Diagnosed With Cancer".

Our law firm is currently investigating possible Zantac cancer lawsuits for personal injury and wrongful death cases.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)