The Food and Drug Administration (FDA) is evaluating several new adverse events – at least one of which was fatal – linked to Cosentyx injection, a medication used to treat adults with plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. The drug was flagged in the quarterly (January-March 2017) Postmarked Drug and Biologic Safety Evaluations review.
Cosentyx injection, which contains the active ingredient secukinumab, was linked to five different safety issues, including sepsis and infection-related deaths; neutropenia-related serious infection; eczema; lichen planus/lichenoid mucositis; and medication errors.
The FDA provides summary information about ongoing and completed postmarket safety evaluations of adverse event reports made to the FDA regarding new drugs and biologics. The evaluations are conducted to determine if there are any new serious adverse events not previously identified during the drug’s development, if known side effects are being reported in unusual numbers, or if there are any potential new safety concerns now that the medication is being used by the general population. These evaluations are performed 18 months after a drug’s approval or after it has been used by 10,000 individuals.
The data is reviewed by scientists from the Office of Surveillance and Epidemiology and Office of New Drugs in the Center for Drug Evaluation and Research. When necessary, a plan is developed to further investigate potential new safety issues.
The FDA said it is evaluating the adverse events and deaths associated with Cosentyx to determine if regulatory action is required.
Any adverse events related to Cosentyx should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Postmarket Drug and Biologic Safety Evaluations