Did you know that the FDA recently placed acne medications with benzoyl peroxide and salicylic acid on its latest quarterly “MedWatch list”? Products containing these agents are widely available over the counter, and they have been considered benign and safe for many years.
Did you know that the FDA recently placed acne medications with benzoyl peroxide and salicylic acid on its latest quarterly “MedWatch list”? Products containing these agents are widely available over the counter, and they have been considered benign and safe for many years. In fact, they are aggressively marketed and widely used. But now the FDA says it recently identified “potential signals of serious risks/new safety information” that raised a red flag.When a product attracts attention from regulators, it may invite potential litigation. For this reason, it is important that you stay on top of the FDA’s MedWatch list to prepare for possible legal challenges.
The MedWatch list includes products that the FDA identified as having “potential signals of serious risk” based on its Adverse Event Reporting System (FAERS). Benzoyl peroxide and salicylic acid landed on the list due to reports of hypersensitivity and anaphylactic reactions. The FDA does not explain the methodology it uses to determine which products make the list. However, we do know that the FDA developed an algorithm to identify an increase in reports of adverse events. The algorithm is known as multi-item gamma-poisson shrinkage or MGPS. Another well-known algorithm, the proportional reporting ratio (PRR), produces results that are similar to the MGPS. Most likely the FDA uses a variation or combination of MGPS, PRR and other algorithms to compile the watch list.
As we have stressed in this blog, a safety signal does not mean reasonable evidence for a causal inference exists (see challenging adverse event reporting evidence and 8 reasons litigators should perform a FAERS signaling analysis.) The most recent notable example is incretin-based therapies and pancreatic adverse events (see FDA’s MedWatch advisory on this topic). In our blog post on this topic, we pointed out the flaws in the scientific case against incretin-based therapies.
You can subscribe to MedWatch safety alerts here. Subscribing to the list will allow you to stay on top of the regulatory arena and avoid surprises in the legal arena. If your client’s product lands on the list, a thorough evaluation of the FAERS data that triggered the alert and an analysis of the available scientific research on the product may be warranted.
This post was drafted by David H. Schwartz, a principle at Innovative Science Solutions, and John Clark, MD,MSPH, who provides expertise to ISS in litigation involving pharmacovigilence and adverse event reporting. Dr. Clark has consulted with corporations and defense counsel on mass tort and complex litigation for the past three decades. He has worked with individual clients and industry groups on management of some of the country’s largest and most prominent pharmaceutical issues. Dr. Clark is the president and chief medical officer at PCSglobal, a pharmaceutical, biotechnology and medical device industries consulting company specializing in risk-reduction services.
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