TAMPA, Fla., Nov. 28, 2023 /PRNewswire/ -- The Obesity Action Coalition (OAC) announces the publication of a "Joint Statement in Support of Closing Gaps in the Drug Approval Process and Drug Labeling for People with Obesity." The statement is co-signed by the OAC, The Obesity Society, the Stop Obesity Alliance, the Obesity Medicine Association, and the American Society for Metabolic and Bariatric Surgery—the leading scientific, medical, and patient advocacy organizations in support of people with obesity.
The statement, which can be found at obesityaction.org/statement-drug-approval-labeling, calls for the U.S. FDA to close gaps in the testing and approval process for drugs intended for use by people with obesity for conditions other than obesity. The statement also urges drug companies that are currently marketing drugs that have issues with safety or effectiveness for people with obesity to update their labeling immediately to provide appropriate usage instructions.
People with obesity make up 42% of the U.S. population, yet there is no requirement that new prescription drugs be shown to be safe and effective for people with obesity before FDA approves them. This means that every day, people with obesity are using FDA-approved drugs without full assurance that they are safe and effective for them.
Drugs that may present issues for people with obesity include drugs in many familiar categories, including emergency birth control, depression, and pain relief. One example, Rexulti, is used to treat schizophrenia and depression. Used as labeled, Rexulti has been shown to underdose people with obesity, which could lead patients or their doctors to discontinue use. A person with undertreated schizophrenia or depression can be at risk of harming themselves or others or committing suicide. Another example is Noxafil, an antifungal treatment.
"Proceedings of a workshop organized in part by FDA scientists dealing with this subject were published this month,1 which tells us that FDA is fully aware of this issue," says Joe Nadglowski, President and CEO of the OAC. "Everyone deserves to know the drugs they use are safe and effective. The FDA and drug companies need to take action now."
The Obesity Action Coalition (OAC), a more than 80,000-member-strong National nonprofit organization, is dedicated to improving the lives of individuals affected by the disease of obesity through education, advocacy and support.
1Available at https://doi.org/10.1002/jcph.2264
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The statement, which can be found at obesityaction.org/statement-drug-approval-labeling, calls for the U.S. FDA to close gaps in the testing and approval process for drugs intended for use by people with obesity for conditions other than obesity. The statement also urges drug companies that are currently marketing drugs that have issues with safety or effectiveness for people with obesity to update their labeling immediately to provide appropriate usage instructions.
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People with obesity make up 42% of the U.S. population, yet there is no requirement that new prescription drugs be shown to be safe and effective for people with obesity before FDA approves them. This means that every day, people with obesity are using FDA-approved drugs without full assurance that they are safe and effective for them.
Drugs that may present issues for people with obesity include drugs in many familiar categories, including emergency birth control, depression, and pain relief. One example, Rexulti, is used to treat schizophrenia and depression. Used as labeled, Rexulti has been shown to underdose people with obesity, which could lead patients or their doctors to discontinue use. A person with undertreated schizophrenia or depression can be at risk of harming themselves or others or committing suicide. Another example is Noxafil, an antifungal treatment.
"Proceedings of a workshop organized in part by FDA scientists dealing with this subject were published this month,1 which tells us that FDA is fully aware of this issue," says Joe Nadglowski, President and CEO of the OAC. "Everyone deserves to know the drugs they use are safe and effective. The FDA and drug companies need to take action now."
The Obesity Action Coalition (OAC), a more than 80,000-member-strong National nonprofit organization, is dedicated to improving the lives of individuals affected by the disease of obesity through education, advocacy and support.
1Available at https://doi.org/10.1002/jcph.2264
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SOURCE Obesity Action Coalition
