Failure to List Zithromax Side Effects on Brochure Could Lead to More Lawsuits
By Andrea Gressman
It has been reported that on June 19, 2012, the FDA sent a letter to Pfizer, the manufacturer of the antibiotic Zithromax, regarding some of the information that is being provided as well as information that has been omitted from the Zithromax promotional brochure regarding Zithromax side effects. It is still unclear if the potential legal ramifications that Pfizer’s decision to withhold this information may cause the company in the future. However, it does not look good that a drug manufacturer would omit such important facts when so many people are experiencing such severe side effects due to using Zithromax (also known as Z-Pak) when the information they chose to exclude could have protected them.
As Zithromax lawsuits continue to be filed, the fact that Pfizer did not include warnings of potential Z-Pak in the Zithromax brochure, and then received a warning letter directly from the FDA, could potentially be a huge blow to Pfizer’s defense in their future Zithromax lawsuit litigation.
It has been reported that the FDA criticized Pfizer for reducing the seriousness of certain Zithromax side effects and completely omitted others from the brochure they use to market Zithromax. The FDA letter to Pfizer addresses several issues, including the following:
* The brochure broadens the use of Zithromax instead of focusing on exactly what the FDA approved it for.
* It omits certain side effect risk information completely.
* It minimizes other side effect risk information.
* It makes claims of being superior when these claims have been unsubstantiated.
* It completely omits important facts all together.
* It makes claims of being superior in efficacy that are misleading.
* It makes additional claims that have been unsubstantiated.
It was also noted by the FDA that Pfizer did not present all of the side effects of Zithromax/Z-Pak and missed some of the warnings that could potentially mislead those who were reading the brochure and relying on it as a resource. The FDA also noted how Pfizer used certain formatting tricks to “hide” some of the important side effects Zithromax users need to be aware of by placing them in hard to read locations. They also used other formatting techniques to ensure that the side effects were minimized and did not stand out in any way.
Side Effects Left Out of Zithromax Brochure
One of the most important elements to the FDA’s claim is that Pfizer left out warnings of potential side effects linked to Zithromax. Some of these include:
* Heart side effects
* QT prolongation
* Cardiac arrhythmia
* Torsades de pointes
* Stevens-Johnson syndrome (SJS)
Many of these heart side effects and Stevens-Johnson Syndrome (SJS) symptoms are potentially fatal, which was obviously not included in the Zithromax brochure as well.
It was ordered by the FDA that Pfizer no longer distribute the Zithromax brochure, but that does not do a lot for those who have already taken Zithromax and experienced side effects or who have already formed the opinion that Zithromax is completely safe based on the information that the brochure provided to them previously. As a result, there will most likely be many more Zithromax lawsuits to come in the future.
The FDA gave Pfizer only 2 weeks to respond to the notice and in an official statement provided by Pfizer they said that they were no longer using the brochure after receiving the FDA letter.
Current Zithromax Side Effect Investigations Continue
There are currently qualified Zithromax lawsuit attorneys investigating side effect claims on behalf of patients who experienced negative Zithromax side effects. If you have experienced Z-Pak side effects such as heart problems of Stevens Johnson Syndrome may be entitled to compensation for pain and suffering, medical expenses, lost wages as well as other injuries. Learn more about Zithromax lawsuits by visiting the Zithromax, Z-Pak, Azithromycin Heart Attack, Stevens-Johnson Syndrome & Toxic Epidermal Necrolysis Class Action Lawsuit Settlement & Investigation page today.
Updated November 22nd, 2012
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.
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2 thoughts onFailure to List Zithromax Side Effects on Brochure Could Lead to More Lawsuits
I was given this antibiotic completely unaware of the side effects, or how long the chemical would remain in my system. I am experiencing major hair loss, currently at 50% and still losing more daily. I’m developing aching joints, small white bumps under the skin all over my forehead, loss of concentration, extreme anxiety/panic attacks, lower abdominal pain, and bloody stool. I took zithromax in July 2012 and from what I have read on line since then, and from speaking to my pharmacist I am not the only one exhibiting these and other side effects from zithromax. I now know that this medicine remains in your system and liver for 4 to 6 months after taking it. I read that many others have been experiencing similar symptoms as I am and they, like myself, were not informed of the possibility of such severe side effects . If I had known I would have never taken it. Its definitely a big price to pay to keep an extracted tooth from becoming infected. I read that zithromax is contra indicated for use with many common medications. I was on 2 of those at the time and was not told nor was any of this explained in the packaging included with the antibiotic. One independant study of people having taken this drug showed that the hair loss in women 35 to 50 years old is more extensive than with men or other age groups and the hair had not grown back in 100% of the people in the study. If an independant study and regular people like myself can see the connection and find the drug dangerous and an unpredictable time bomb, why didn’t the manufacturer bother to let us know. We all know that the extensive trials done on this drug must have shown something, especially if the layperson, unknowing victim can put it together on our own and see the benefits are not worth the side effects of this medication. I want my hair back, and not to have to hide my balding head. My joints ache and I want to know who is going to help me get back my health. I also want the truth and full disclosure to let me know what other symptoms I can expect or may have now but are hidden that I need to watch or be tested for.
oNE MONTH AGO I HAD TO HAVE A STENT PUT IN BECAUSE OF A 98% BLOCKAGE. i HAVE USED SEVERAL OF THE THESE IN THE PAST SEVERAL YEARS. i DON’T KNOW IF THIS QUALIFIES ARE NOT