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Heat Affects Absorption Rate
"FDA Will Launch a Medical Patch Review, Including Ortho Evra"
The Food and Drug Administration announced last week it will launch an “exhaustive review” concerning the safety of medical patches, including Ortho Evra birth control patch and fentanyl pain patch both manufactured by Johnson & Johnson.
As drug companies continue to produce more and more patches—the FDA just approved the first antidepressant patch last week—researchers worry medical patches may become unsafe when exposed to heat from exercise, hot tubs, or fevers, which could lead to fatal results.
“Most people don''t realize that heat is going to increase absorption rates, even to toxic levels,” said Michael Cohen, director of the Institute for Safe Medication Practices. “It''s something patients should be warned about.”
In the last two decades, patch medications, used by over 12 million people, have evolved to include more than 30 different prescriptions used for a variety of conditions such as bladder control and heart disease. However, concerns regarding the safety of patch use continue to rise as more information about adverse side effects are revealed.
In November, the FDA issued a “black box” warning label on Ortho Evra, after studies found that birth control patch users were exposed to 60 percent more estrogen than those taking oral contraceptives, increasing the risk of potentially fatal side effects.
Furthermore, according to FDA reports, the fentanyl patch, which is one hundred times stronger than morphine, has been linked to 120 deaths since it was released in 1990.
In 2004, medical patches were thought to be the primary cause of death in eight cases, including two teenagers on the birth control patch. And in 2003 and 2004, at least 30 cases of hospitalization, disability, or life-threatening complications were connected to the use of medical patches.
“The problems are real, they''re happening and they''re underreported,” said Michael Cohen, director of the Institute for Safe Medication Practices.
Johnson & Johnson spokesman, Douglas Stokke, said doctors should be wary of the risks associated with patch use and aid in warning their patients. “Physicians should be knowledgeable about the prescribing information for these products and should be prescribing them according to label,” he said.
According to Lucinda Buhse, director of the FDA''s Division of Pharmaceutical Analysis, the agency recently began to look into how heat affects the absorption rate of medical patches under different circumstances. For now, the study will focus mainly on fentanyl and Ortho Evra patch, but eventually all medical patches will be tested.
Have you been injured by the Ortho Evra Patch?
Lawsuits have already been filed on behalf of women who have suffered a fatal blood clot from the Ortho Evra birth control patch. Please contact an experienced Ortho Evra birth control patch attorney to learn more about your legal rights.
