Teva Pharmaceuticals is halting sales of headache patch Zecuity amid reports that patients have been burned by the product. This is a significant step that would certainly appear to validate recent safety concerns relating to the Zecuity patches. The development came less than two weeks after the U.S. Food and Drug Administration (FDA) said that “a large number of patients” have experienced “serious burns and potential permanent scarring” when using Zecuity, which hit the market in September for treatment of migraine headaches.
Teva, in an urgent letter sent to health care providers on June 9, asked doctors to stop prescribing Zecuity. The anti-headache drug sumatriptan is delivered to the bloodstream by way of the patch more quickly than pills. Doctors should tell patients with existing prescriptions to discontinue use of Zecuity, the letter stated. Teva’s letter also acknowledged that some patients have suffered long-lasting side effects from Zecuity. The battery-powered patch is applied for several hours to the upper arm or thigh. Teva acknowledged that “Although many cases resolved within hours to weeks, there are reports of cases with unresolved skin reactions, typically skin discoloration, after several months.”
The company also disclosed a recall of Zecuity that will extend to the pharmacy level, a moderately extensive type of recall that goes beyond the distributor level but not all the way to consumers. Teva said that it is working with the FDA “to better understand these adverse events.” The product was originally developed by Pennsylvania-based NuPathe Inc., which Teva acquired in 2014.
According to Teva, injuries have been described as “severe redness, cracked skin, blistering or welts, and burns or scars where the patch was worn.” Zecuity’s label lists skin redness as the product’s most common side effect and says that discoloration normally disappears within 24 hours. Information contained in the label indicates “intense redness” or “intense redness with blisters/broken skin” was reported in 6 percent of clinical-trial patients within four hours of using Zecuity, a figure that fell to 2 percent within 24 hours.
Thus far, there are no specific figures on the number of serious skin reactions to Zecuity, outside of clinical trials, that have been made public. It’s not common for drugmakers to suspend sales in the face of new safety concerns.
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