On January 19, 2006, the FDA announced the approval of a BLACK BOX WARNING for Protopic Ointment to warn of the serious risk of cancer posed by this topical prescription medication. Evidence shows that Protopic increases the risk of skin cancer and lymphomas. If you or a loved one has developed cancer or other serious side effects while using Protopic, please contact us at Oshman & Mirisola to learn more about your legal rights and options. You may be eligible to receive compensation for your losses and suffering.
What is Protopic?
The FDA approved Protopic (tacrolimus ointment) in 2000. This topical ointment is used to treat moderate to severe atopic dermatitis, also known as eczema. Protopic is not intended for use in children under the age of two. Astellas Pharma, Inc. (formerly known as Fujisawa Healthcare) manufactures Protopic ointment. Due to known Protopic side effects, this medication should only be used for a short period of time. Protopic is not intended for long-term use.
Experts also warn that Protopic should only be used as a “second-line” treatment when other medications have not successfully treated a patient’s eczema. Protopic may also be recommended when other medications have caused significant side effects. Nonetheless, Protopic should only be prescribed as a last resort treatment of eczema.
What is eczema?
Eczema, or atopic dermatitis, is one of the most common skin conditions experienced by infants and young children. Experts estimate that 10 to 15 percent of all children suffer from eczema. In the majority of cases, eczema is resolved by the time these children enter their teens. However, for some patients, treatments are necessary to treat eczema.
Eczema is characterized by chronically itchy, dry, red, and scaly skin. Because patients often have an overwhelming urge to scratch at infected areas, significant skin damage can result. Although the exact cause of eczema is unknown, many experts believe there is an allergic or immune component to the condition.
Protopic, and a similar drug called Elidel (marketed by Novartis AG), are approved to treat eczema. While the exact function of these topical drugs are not well understood, it is thought that Protopic and Elidel have various effects on the immune system.
Protopic Side Effect Risks
Serious Protopic side effects can include:
* VIRAL INFECTIONS Protopic can increase the risk of getting shingles, chicken pox, or other viral infections.
* SKIN IRRITATION While Protopic is intended to relieve symptoms of skin irritation, this drug can also aggravate skin problems. Protopic side effects can include stinging, soreness, a burning sensation, or itchy skin.
* FLU-LIKE SYMPTOMS Protopic can cause a patient to develop symptoms of the flu and headaches. This may be due to the drug’s effects on the immune system.
* SKIN CANCER AND LYMPHOMA Protopic cancer is a serious risk associated with this medication.
2005 FDA Warning over Protopic Cancer
In March 2005, the FDA issued an advisory warning to inform consumers about the rare but serious risk of Protopic cancer. Based on information from animal studies, human case studies, and knowledge of the drug’s function, Protopic appears to increase the risk of developing skin cancer and lymph node cancer (lymphoma).
Studies also show that skin tumors developed faster in subjects, treated with Protopic, who have been exposed to light. Therefore, patients undergoing light therapy for their skin condition, other forms of phototherapy, or those with a lot of exposure to the sun, may be at an increased risk for Protopic cancer.
When the FDA advisory warning was issued, the FDA stated that it might take ten or more years to determine if Protopic is undeniably linked to cancer. They announced that further studies would be conducted to learn more about the serious risks of Protopic cancer.
2006 Protopic Cancer BLACK BOX WARNING
In January 2006, the FDA announced that a black box warning, the strictest warning short of a recall, would be added to Protopic labeling to warn of the serious risks of cancer. The agency also issued a Medication Guide to help ensure that patients are aware of the serious risks of Protopic cancer.
The Protopic black box warning also reiterates that Protopic should only be used as a second-line treatment in patients who have not received relief from other medications who do not have any risk factors for Protopic side effects. Protopic’s maker and the FDA state they will continue to evaluate Protopic safety to determine the exact causation between this drug and various forms of cancer.
Injured by Protopic?
If you or a loved one has suffered serious Protopic side effects, please contact us to speak with a qualified attorney at Oshman & Mirisola about your legal rights and options. We are experienced in handling cases of a similar nature and are prepared to protect and maximize your legal interests. You may be eligible to seek compensation for your losses and suffering.