E-DRUG: Importance of post market pharmacovigilance with new products
-----------------------------------------------------------------------------------------
Dear e-drug readers
Very interesting article from the JAMA last issue:
Postmarket Safety Events Among Novel Therapeutics Approved by the US Food
and Drug Administration Between 2001 and 2010
http://jamanetwork.com/journals/jama/article-abstract/2625319
Key Points
Question Are characteristics of novel therapeutics known at the time of US
Food and Drug Administration (FDA) approval associated with postmarket
safety events, including withdrawal, boxed warnings, and safety
communications?
Findings Among 222 novel therapeutics approved by the FDA from 2001
through 2010, 71 (32.0%) were affected by a postmarket safety event.
Postmarket safety events were more frequent among biologics, therapeutics
indicated for the treatment of psychiatric disease, those receiving
accelerated approval, and those with near–regulatory deadline approval.
Meaning Postmarket safety events are common after FDA approval,
highlighting the importance of continuous monitoring of the safety of novel
therapeutics throughout their life cycle.
Abstract
Importance Postmarket safety events of novel pharmaceuticals and biologics
occur when new safety risks are identified after initial regulatory
approval of these therapeutics. These safety events can change how novel
therapeutics are used in clinical practice and inform patient and clinician
decision making.
Objectives To characterize the frequency of postmarket safety events among
novel therapeutics approved by the US Food and Drug Administration (FDA),
and to examine whether any novel therapeutic characteristics known at the
time of FDA approval were associated with increased risk.
Design and Setting Cohort study of all novel therapeutics approved by the
FDA between January 1, 2001, and December 31, 2010, followed up through
February 28, 2017.
Exposures Novel therapeutic characteristics known at the time of FDA
approval, including drug class, therapeutic area, priority review,
accelerated approval, orphan status, near–regulatory deadline approval, and
regulatory review time.
Main Outcomes and Measures A composite of (1) withdrawals due to safety
concerns, (2) FDA issuance of incremental boxed warnings added in the
postmarket period, and (3) FDA issuance of safety communications.
Results From 2001 through 2010, the FDA approved 222 novel therapeutics
(183 pharmaceuticals and 39 biologics). There were 123 new postmarket
safety events (3 withdrawals, 61 boxed warnings, and 59 safety
communications) during a median follow-up period of 11.7 years
(interquartile range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the
novel therapeutics. The median time from approval to first postmarket
safety event was 4.2 years (IQR, 2.5-6.0 years), and the proportion of
novel therapeutics affected by a postmarket safety event at 10 years was
30.8% (95% CI, 25.1%-37.5%). In multivariable analysis, postmarket safety
events were statistically significantly more frequent among biologics
(incidence rate ratio [IRR] = 1.93; 95% CI, 1.06-3.52; P = .03),
therapeutics indicated for the treatment of psychiatric disease (IRR =
3.78; 95% CI, 1.77-8.06; P < .001), those receiving accelerated approval
(IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and those with near–regulatory
deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); events were
statistically significantly less frequent among those with regulatory
review times less than 200 days (IRR = 0.46; 95% CI, 0.24-0.87; P = .02).
Conclusions and Relevance Among 222 novel therapeutics approved by the FDA
from 2001 through 2010, 32% were affected by a postmarket safety event.
Biologics, psychiatric therapeutics, and accelerated and near–regulatory
deadline approval were statistically significantly associated with higher
rates of events, highlighting the need for continuous monitoring of the
safety of novel therapeutics throughout their life cycle.
Best regards
Etienne
Etienne Guillard - PharmD, MSc
Health Services & Systems Strengthening Director
SOLTHIS
www.solthis.org
Etienne Guillard <etienne.guillard@gmail.com>