Five Drugs Added to FDA Watch List
Medscape reports that the U.S. Food and Drug Administration (FDA) has added four cancer drugs and a generic drug that treats attention-deficit/hyperactivity disorder (ADHD) on its quarterly list of products to be monitored.
Four Cancer Drugs Linked to Deadly Skin Reactions
Based on reports received through the FDA Adverse Event Reporting System (FAERS) over the last three months of 2013, the FDA has decided to add four cancer treatments to its watch list:
- Lapatinib (Tykerb, GlaxoSmithKline)
- Pazopanib (Votrient, GlaxoSmithKline)
- Sorafenib (Nexavar, Bayer HealthCare Pharmaceuticals)
- Sunitinib (Sutent, Pfizer)
The FAERS data suggested that the kinase inhibitor products may be linked with bullous skin conditions, including Steven-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
These painful skin reactions can be fatal are marked by flu-like symptoms followed by a purplish rash that spreads and blisters. The top layer of the skin then dies and begins to shed. Both SJS and TEN can be fatal.
ADHD Facing Quality Concerns
The FDA also added generic versions of methylphenidate hydrochloride (Concerta, Janssen Pharmaceuticals) to its watch list due to a possible lack of therapeutic benefit and concerns of product quality.
The agency is now studying whether there is a causal risk associated with the drug. If one is established, the FDA may then consider a regulatory response.
Reponses could include changes to the drug’s label or mandating a risk evaluation and mitigation strategy.