Patient Safety is Priority #1 at TevaLast Updated:
A few days ago, Teva Pharmaceuticals announced a voluntary suspension of marketing, sales, and distribution of Zecuity (sumatriptan iontophoretic transdermal system) after reports of “severe redness, pain, skin discoloration, blistering, and cracked skin.” These adverse events were not observed during clinical trials, so Teva is working with the FDA to determine their cause.
“At Teva, the well-being of people using our products is always the first priority. Given our deep commitment to patient safety, we will engage in a voluntary suspension of marketing while we continue our investigation into the root cause of these adverse skin reactions…We will continue to work closely with the FDA to resolve any remaining questions.”
Rob Koremans, M.D., President and Chief Executive Officer of Global Specialty Medicines
Post-market adverse events are not all that uncommon. It happened with Vioxx, too. During clinical trials, patients are carefully screened and monitored. That isn’t always the case when a drug is made available to the public. We won’t know for quite some time exactly what happened and why. In fact, the results may not be readily available or accurately reported to the mainstream public. News outlets make their money based on ratings. Sensation and controversy make for great news. If the end result of investigation into Zecuity is neither sensational or controversial, most people will not ever hear about it.
A recall isn’t necessarily evidence that Teva did anything wrong in the development and production of Zecuity. In fact, a voluntary recall is a good sign that Teva’s leadership has integrity and is committed to patient safety. They didn’t wait for the FDA to issue a mandatory recall. In fact, they pulled the product right in the middle of the American Headache Society’s 58th Annual Scientific Meeting and dismantled the promotional display that would have debuted Zecuity to the country’s leading headache doctors.
You won’t find any pharma-bashing here at Brain Storm. I have a great deal of respect for Teva Pharmaceuticals. It is obvious to me that are committed to putting patient welfare at the forefront of their business. I trust them even more now.