by ecancer reporter Janet Fricker

Just under one third of novel therapeutics have been affected by a postmarket safety event by 10 years after Federal Drugs Administration (FDA) approval, finds a US study published in JAMA.

Postmarket safety events were more frequent among biologics, therapeutics receiving accelerated approval and those with near-regulatory deadline approvals.

The investigators also found that of eight therapeutic areas explored, postmarket events were highest for psychiatric treatments and lowest for cancer and haematology treatments.

Joseph Ross and colleagues, from Yale University School of Medicine, New Haven, set out to characterize the frequency of postmarket safety events and associations for increased risk among novel therapeutics receiving FDA approval between January 2001 and December 2010.

The investigators used the Drugs@FDA database to identify novel therapeutics which were classified into one of eight therapeutic areas – autoimmune, musculoskeletal, and dermatology; cancer and haematology; cardiovascular disease, diabetes, and hyperlipidaemia; genitourinary and renal; infectious disease; neurology; psychiatry; and other.

Therapeutics were followed through to February 28 2017.

Results showed between 2001 and 2010, the FDA approved 222 novel therapeutics consisting of 183 pharmaceuticals and 39 biologics.

The median total review time was 311 days, with a total review time less than 200 days for 54 novel therapeutic (24.3%).

Overall, 123 safety events occurred including three withdrawals, 61 boxed warnings and 59 safety communications.

The median time from approval to first postmarket safety event was 4.2 years, and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 30.8%.

In a multivariable analysis, post market safety events were most common for psychiatric treatments and least common for cancer and haematologic disease treatments (60% versus 21.4%; p=.006).

“The high frequency of postmarket safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle,” conclude the authors.

Further research, they add, is needed to better understand the dynamics between more rapid and near-regulatory deadline approval and drug safety.

Reference
Downing NS, Shah ND, Aminawung JA, et al. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA. 2017, 317, 1854-1863