According to an announcement made by Arizona’s Attorney General, the Consumer Protection & Advocacy Section in Tucson has reached a multi-million dollar settlement with Zithromax manufacturer, Pfizer. The Zithromax settlement was the end result of an investigation that was conducted in order to determine if the DTC (direct-to-consumer) advertising campaign, implemented by Pfizer, included all pertinent information, including the potential risks of the antibiotic. The investigation also looked into the materials Pfizer used to promote the product.
Zithromax, also known as Z-Pak, as well as azithromycin, is part of a group of medications called macrolide antibiotics, used to fight bacteria in the body. It is one of the most popular antibiotics on the market, treating a variety of infections in the young and old. Some of the conditions Zithromax is used for include ear infections, skin infections, sexually transmitted diseases and respiratory infections, such as bronchitis and pneumonia.
Many drug manufacturers use DTC advertising methods to bring awareness about their drugs to the public. In the case of Zithromax, Pfizer marketed the benefits of this antibiotic to parents of children with ear infections, especially the fact that Zithromax is taken only for a few days as compared to a ten-day regimen of other comparable antibiotics. However, the Attorney General claims that Pfizer overstated the benefits and efficiency of Zithromax when compared to similar antibiotics. The Attorney General also stated that Pfizer only spoke about the benefits of Zithromax and never discussed any side effects that doctors need to address when prescribing a medication.
It has also been stated that Pfizer could not make the representation of Zithromax being more convenient due to the shortened amount of time the patient must take the antibiotic without making the following statement as well, “Your doctor will consider many factors when choosing an antibiotic. Dosing convenience is a consideration that may affect your doctor’s choice of treatment for your child’s ear infection.”
Another statement must also be included from now on in Pfizer’s advertisements for Zithromax, “Remember that antibiotics do not work for viral infections, such as a cold or flu, so do not insist on a prescription for an antibiotic. Only your doctor can decide what type of infection your child has and the best way to treat it.”
First introduced to the medical market in 1991, Zithromax is manufactured and distributed by Pfizer. Generically known as azithromycin, what made this new antibiotic so attractive was the decreased treatment period when compared to other antibiotics used for the same symptoms. Typically, two pills in the Z-Pak are taken on the first day, followed by one pill daily for a total of five days, as compared to taking three pills daily for ten days. The same end result is supposedly achieved, without having to remember to take a pill three times a day. It is also available in generic form. In 2011, doctors wrote more than 55.3 million prescriptions for the drug and global sales exceeded $1.8 billion.
However, because so many people are unaware of the potential of developing extreme side effects from Zithromax, the antibiotic is widely prescribed. As a result, there are many Z-Pak side effect victims out there facing very serious injuries, which are not only painful, but can affect the patient for the rest of their lives.
In May 2012, the FDA announced that they were reviewing potential Zithromax side effects and reports of heart injuries and deaths related to the use of Z-Pak. The researchers analyzed data on more than 540,000 people in Tennessee between the ages of 30-74 from 1992 to 2006. The study showed users of the antibiotic had an increased risk of death within the first five days of using the medication. The study, published in the New England Journal of Medicine, cited researchers from Vanderbilt University that discovered those who used Zithromax were 2.5 times more likely to suffer fatalities linked to Zithromax-related cardiovascular problems than patients who were prescribed Amoxicillin. Nearly 540,000 patients that took Z-Pak’s 5-day treatment during the 14-year period, showed 29 heart-related side effect deaths. Zithromax more than doubled their side effect risk of death while taking this drug in comparison to patients who took Amoxicillin.
The study indicated a link between the use of Zithromax and dangerous changes in heart rhythms, which includes QT interval prolongation. These types of changes can lead to a heart condition known as Torsades de Pointes, which can be fatal.
It was recently reported that the U.S. Food and Drug Administration (FDA) sent a warning letter to Pfizer Inc. over “false or misleading” statements they used in a brochure to advertise the antibiotic Zithromax, or Z-Pak. The FDA stated that the brochure made unsupported claims about what benefits Zithromax provides and did not include important side effect risk information.
According to the FDA, Pfizer misrepresented the effect Zithromax can have on a patient. The agency also addressed the following problems in the brochure:
– Minimizes important side effect risk information
– Makes claims that are unsubstantiated and claim superiority over other antibiotics
– Does not include important facts
– Expands the indications for the antibiotic
– Makes claims that are misleading regarding efficiency
– Makes claims that are unsubstantiated claims for Z-Pak
The FDA concluded that the advertisements have misbranded Zithromax and Z-Pak in violation of the Federal Food, Drug, and Cosmetic Act. Zithromax received its approval from the FDA as a treatment option for bacterial infections that have been classified as mild to moderate and can cause acute bacterial sinusitis. Zithromax was also approved as a treatment option for community-acquired pneumonia.
The FDA expressed concerns because the Zithromax brochure “omits the important risk of QT prolongation” that has been linked to Zithromax and Z-Pak use. Patients that suffer from prolonged QT intervals have the side effect risk of very serious cardiac arrhythmias that can be fatal.
The brochure also minimizes the side effect risk of the patient developing life-threatening allergic reactions such as Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) that Zithromax has previously been linked to causing.
As a part of the FDA’s warning level, the agency has requested that Pfizer stop using the promotional material they have identified as false and misleading for Zithromax and Z-Pak.
There have been a number of patients that have experienced serious side effects after taking Zithromax. Many of them have filed Zithromax lawsuits. The statements that the FDA made regarding the misleading and false statements of the Zithromax brochure have certainly added to the credibility of the Zithromax lawsuits.
Zithromax lawsuits against Pfizer allege that the company failed to properly research potential side effects and warn users of the increased risk of heart problems. When the amount of Z-Pak prescriptions are considered, there are thousands of potentials victims who may have suffered one of the cardiac side effects as a result of Pfizer’s failure to properly research the potential risks associated with Zithromax.
Some of the Zithromax lawsuits have been filed on behalf of the patients who have died after using the antibiotic. Heart problems that have been linked to Zithromax include:
– Cardiovascular Death
– Heart Arrhythmia
– Heart Attack
– Torsades de Pointes
Pfizer’s failure to properly research and test their drug has caused several deaths which may have been avoided had the public been properly warned. If you or a loved one has taken Zithromax and has suffered any of the serious side effects, including death, you may be entitled to received compensation.
It is also a requirement of the Zithromax settlement that Pfizer now give $2 million in funding to public service announcements for the next three cold seasons, which take place from November to March. They will have to promote awareness that the medical community has to take in factors such as antibiotic resistance, as well as others, when an antibiotic is being prescribed. Pfizer also has to pay a total of $4 million in costs, as well as attorney’s fees. Arizona will receive $127,273 from the agreed upon Zithromax settlement.
The other states included in the Attorney General investigation include the following:
|New York||North Carolina||Ohio|
The general public has not realized the concerns about Zithromax side effects. This is especially true in Florida, where so many people think antibiotics will solve their medical problems.
People in Florida visit urgent care centers as “Z-Pak Clinics,” a local doctor told USA Today. They ignore the fact that coughs and many other infections simply do not respond to the medication, and shop around until someone writes a prescription for it. Unfortunately, many doctors are too harried, especially in these cash-for-service institutions, and write them anyway. There are several problems with this. Firstly, Zithromax does not work for viral infections. Secondly, doctors know that Z-Pak heart attack problems are real, but few doctors consider Stevens Johnson Syndrome. The potentially fatal disorder starts as a rash on the extremities, but causes major autoimmune problems. It is also a potential side effect of Zithromax.
As if these weren’t enough reasons not to take Zithromax, there is another serious side effect to be aware of. Zithromax has also been linked to causing kidney failure as a potential side effect to its users. Some of the symptoms associated with Zithromax kidney failure include decreased urine production, drowsiness, vomiting or even going into a coma.
It seems like all these side effects are more than enough reasons to think twice, or three times, before filling a Z-Pak prescription! The pharmaceutical companies care about their pocketbooks more than the safety and wellbeing of the consumer. Feel free to comment on this blog post. You can contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).