Follow us on
Twitter and
Facebook for the latest Zithromax Class Action Lawsuit News!
FDA Warns Pfizer to Include Zithromax Stevens Johnson Syndrome Risks on Brochure
By Mike Holter
Concern over the lack of adequate warnings regarding Zmax side effects has prompted the U.S. Food and Drug Administration to issue a warning letter to Pfizer to update its promotional materials to include possible Zithromax side effects such as Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, and other serious skin allergic reactions. Zmax is a single-dose version of Zithromax — known generically as azithromycin and popularly as Z-Pak — that has been targeted in hundreds of lawsuits seeking compensation for undisclosed side effects.
According to the FDA warning letter, dated June 19, 2012, brochures for Zmax omit the risk of heart problems associated with Zithromax use and minimized the risks of fatal allergic and skin reactions such as Stevens Johnson Syndrome (SJS) — a severe condition that causes large areas of the skin to blister and peel, causing open sores and infection. In the later stages of SJS, Toxic Epidermal Necrolysis (TEN) can develop — a life-threatening disease that causes large areas of the skin to become detached and lesions to develop in the mucous membranes, causing infection and sometimes death. Although Pfizer acknowledges the risk of Zithromax Stevens Johnson Syndrome on the drug’s warning label, the FDA argues the brochure for Zmax does not disclose the severity of the condition, which can be fatal, and does not mention that some allergic symptoms recurred in patients when they discontinued Zithromax, Z-Pak, azithromycin or Zmax.
The warning label for Zmax states: “Serious allergic reactions, including angioedema, anaphylaxis, Stevens Johnson Syndrome and Toxic Epidermal Necrolysis have been reported rarely in patients on azithromycin therapy using other formulations. Although rare, fatalities have been reported.”
The warning label also notes that some patients have suffered recurring symptoms of SJS or TEN despite having no further exposure to azithromycin. However, none of this information is included in the brochure, the FDA says.
Other concerns the agency cited in the warning letter is the lack of warning about the risk of heart problems associated with Zithromax, Z-Pak and azithromycin. The warning was issued after a May 2012 Zithromax study published in the New England Journal of Medicine that found patients using the 5-day course of Z-Pak/Zithromax/azithromycin were twice as likely to die from a heart attack or sudden cardiac event compared to those on the antibiotic amoxicillin.
The FDA gave Pfizer until July 3, 2012 to provide a written response to the agency’s warning letter, which requested that Pfizer stop using the deceptive Zmax brochure. Thousands of Zithromax lawsuits and Z-Pak lawsuits have been filed against Pfizer for failing to adequately warn the public about the risks of serious Zithromax side effects like Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, heart attack, stroke, Trachoma/eye infections/blindness, and more.
If you suffered Stevens Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or another side effect after taking Zithromax, Z-Pak, azithromycin or Zmax, you should be aware of your legal options. The medical expenses alone for treating SJS or TEN can amount to hundreds of thousands of dollars, not to mention the pain and suffering you deserve to be compensated for. A Zithromax compensation specialist can provide a free consultation about your case.
If you would like more information about filing a Zithromax lawsuit, Z-Pak lawsuit or class action lawsuit to get compensation for your injuries, go to the Zithromax, Z-Pak, Azithromycin Class Action Lawsuit Investigation page. You can submit your information, or your loved one’s, to Zithromax attorneys who are actively investigating all claims regarding Zithromax Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and other side effects. Z-Pak attorneys are waiting to talk to you now and the consultation is free. These lawyers don’t get paid unless you win or settle.
We tell you about cash you can claim EVERY WEEK! Sign up for our free newsletter.
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
Various Trademarks held by their respective owners.
One thought on FDA Warns Pfizer to Include Zithromax Stevens Johnson Syndrome Risks on Brochure
my daughter and i was prescribed zithromax on this year, how can i be a part of this class action lawsuit?