Specific Prescribing Information for Geriatric Use in the 2019 Product Labeling for Novel New Drug Approvals

Abstract

Objectives To review the availability of information specific to older people in the product labeling for novel US Food and Drug Administration drug approvals in 2019. Design Descriptive report. Methods Product labeling for the 48 novel new drugs approved by the US Food and Drug Administration in 2019 were analyzed for the presence of information specific to older people. The “Geriatric Use” section, Section 8.5 in the product labeling, was categorized based on the information available. Each product label was further searched using the terms “geriatric,” “elderly,” “old,” and “year.” Searches of the term “old” and “year” focused on information that mentioned adults 65 years of age or older. The sections of the product label that contained additional information related to older people was identified. Results Information was available in the “Geriatric Use” section (Section 8.5) for 46 of the 48 novel new drugs approved in 2019; 2 did not include a “Geriatric Use” section. Four product labels indicated that the drugs were not used in older people. One of the 2 medications whose labeling omitted the “Geriatric Use” section was also not indicated for use in older people. These labels were excluded from analysis.Of the remaining 42 drugs, there was insufficient numbers of patients 65 years of age and older to determine whether older patients responded differently than younger patients for 18 medications. Labeling for 15 medications indicated that there was no difference in safety and/or efficacy between younger and older persons. Product information for 6 medications indicated that the incidence of adverse events was higher for older people. The product label for 2 medications indicated that no dosage adjustment was required in older patients. One medication’s product labeling indicated that there were insufficient numbers of patients 65 years of age or older for 1 indication but that there was no difference in safety and/or efficacy for the medication’s second indication. Additional sections that referred to people 65 years of age and older included warnings and precautions, clinical trial experience, pharmacokinetics for special populations, and clinical studies. The “Geriatric Use” section of 1 product label referred to the dosage recommendations in patients with renal impairment. Conclusion Despite efforts to increase the enrollment of older people in clinical trials, 43% of the novel new drugs approved in 2019 lacked information on differences in response between older and younger populations because of insufficient numbers of study subjects. This paucity of information translates into therapeutic uncertainty regarding the safety and efficacy of these new medications in older people. An additional concern is that 14% of novel new drug labels indicated that older people are at greater risk for adverse events. Limited information specific to older people is available in other parts of the product labeling. More useful information related to older persons needs to be included in new drug labeling.

Geriatric drug trials on solid tumor are scarce worldwide

“…This relatively low number may due to the lack of guidelines regarding adequate evidence on the drug risk-benefit profile among elderly individuals in pivotal trials as well as the lack of impact of inadequate evidence among older cancer patients on market size. Although it is common to report the distribution of participants aged over 65 years and over 75 years in pivotal studies on drug labels, indication approval does not impose any restrictions on data from elderly individuals ( 13 ). Thus, companies have low incentive to initiate geriatric trials; correspondingly, only 19 trials and 54 trials have been independently initiated and coinitiated by companies, respectively, in the past decade.…”