Nav: Home

Safety events common for pharmaceuticals and biologics after FDA approval

May 09, 2017

Among more than 200 new pharmaceuticals and biologics approved by the U.S. Food and Drug Administration from 2001 through 2010, nearly a third were affected by a postmarket safety event such as issuance of a boxed warning or safety communication, according to a study published by JAMA.

The majority of pivotal trials that form the basis for FDA approval for therapeutics (pharmaceuticals and biologics) enroll fewer than 1,000 patients with follow-up of six months or less, which may make it challenging to identify uncommon or long-term serious safety risks.

These risks may only become evident when new therapeutics are used in much larger patient populations and for longer durations in the postmarket period. Postmarket safety events can change how these therapeutics are used in clinical practice and inform patient and clinician decision making.

Joseph S. Ross, M.D., M.H.S., of the Yale University School of Medicine, New Haven, Conn., and colleagues examined safety events (a composite of withdrawals due to safety concerns, FDA issuance of incremental boxed warnings added in the postmarket period, and FDA issuance of safety communications) for all novel therapeutics approved by the FDA between January 2001 and December 2010 (followed-up through February 2017).

During this time period, 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, affecting 32 percent of the novel therapeutics. 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 31 percent. Postmarket safety events were significantly more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near-regulatory deadline approval. Events were significantly less frequent among those with regulatory review times less than 200 days.

The authors write that these findings should be interpreted cautiously but can be used to inform ongoing surveillance efforts.

Limitations of the study are noted in the article.

"The high frequency of postmarket safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle," the researchers write.
-end-
For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.5150)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

To place an electronic embedded link to this study in your story This link will be live at the embargo time: http://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.5150

The JAMA Network Journals

Related Pharmaceuticals Articles:

Study calls for improved sanitation and the environmental management of pharmaceuticals
Failure to ensure the environmental sustainability of growing patient access to medicines in developing economies could increase the risk of adverse environmental impacts, according to new research led by the University of Plymouth.
Chemicals for pharmaceuticals could be made cheaper and greener by new catalysts
High value chemicals used to make pharmaceuticals could be made much cheaper and quicker thanks to a series of new catalysts made by scientists at the University of Warwick in collaboration with GoldenKeys High-Tech Co., Ltd. in China.
Soaking up pharmaceuticals and personal care products from water
Medications excreted in the urine or dumped into the toilet can end up in the water supply, just like lotions or cosmetics that wash off the body and go down the sink or shower drain.
New study finds river wildlife contain cocaine, pharmaceuticals and pesticides
For the first time, researchers at King's College London, in collaboration with the University of Suffolk, have found a diverse array of chemicals, including illicit drugs and pesticides in UK river wildlife.
Metal-free catalyst to convert aldehyde into ketone, a basic structure of pharmaceuticals
We succeeded in synthesizing a ketone, a basic structure of many pharmaceuticals, from an aldehyde and a carboxylic acid using N-heterocyclic carbene catalyst under mild conditions.
Human pharmaceuticals change cricket personality
Crickets that are exposed to human drugs that alter serotonin levels in the brain are less active and less aggressive than crickets that have had no drug exposure, according to a new study led by researchers from Linköping University.
Screen strategies for off-target liability prediction & ID small-molecule pharmaceuticals
A new review in SLAS Discovery explores how improved safety screening strategies and methods are improving the pharmaceutical discovery and development process.
Small amounts of pharmaceuticals found in north central Pa. rural well water
Drinking water from wells in rural north central Pennsylvania had low levels of pharmaceuticals, according to a study led by Penn State researchers.
New molecule to improve pharmaceuticals draws inspiration from nature's toolbox
In the race to create more potent and stable medicines, scientists know that adding fluorine can improve drug molecules.
More communication needed regarding disposal of pet pharmaceuticals
New research found that more than 60 percent of veterinary care professionals do not counsel their clients when it comes to the environmental stewardship aspect of medicine disposal .
More Pharmaceuticals News and Pharmaceuticals Current Events

Top Science Podcasts

We have hand picked the top science podcasts of 2019.
Now Playing: TED Radio Hour

In & Out Of Love
We think of love as a mysterious, unknowable force. Something that happens to us. But what if we could control it? This hour, TED speakers on whether we can decide to fall in — and out of — love. Guests include writer Mandy Len Catron, biological anthropologist Helen Fisher, musician Dessa, One Love CEO Katie Hood, and psychologist Guy Winch.
Now Playing: Science for the People

#543 Give a Nerd a Gift
Yup, you guessed it... it's Science for the People's annual holiday episode that helps you figure out what sciency books and gifts to get that special nerd on your list. Or maybe you're looking to build up your reading list for the holiday break and a geeky Christmas sweater to wear to an upcoming party. Returning are pop-science power-readers John Dupuis and Joanne Manaster to dish on the best science books they read this past year. And Rachelle Saunders and Bethany Brookshire squee in delight over some truly delightful science-themed non-book objects for those whose bookshelves are already full. Since...
Now Playing: Radiolab

An Announcement from Radiolab