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Zithromax

The Zithromax injury case attorneys at the Drug Law Center represent patients who have suffered serious harm or died prematurely after taking the azithromycin medication.

Introduction

Zithromax Drug RecallZithromax (azithromycin) is a semi-synthetic antibiotic medication that kills off bacteria. Many consumers recognize Zithromax as “Z-PAK”, a synthetic macrolide antibiotic. Doctors prescribe the medication to treat numerous forms of infections that include otitis media (middle ear infection), skin infection, respiratory infection, bacterial conjunctivitis, laryngitis, tonsillitis, bronchitis, sexually transmitted disease, bacterial-associated sinusitis, and pneumonia.

The History of Zithromax

In the early 1970s, a research team working for a Croatian pharmaceutical drug maker (PLIVA) discovered the precursor to Zithromax after working with macrolide antibiotics. The results of the research discovered azithromycin and azalides. By 1986, pharmaceutical giant Pfizer signed a licensing agreement with the Croatian medicine manufacturer to obtain the rights of patented azithromycin for sale the United States in Western Europe.

Soon afterward, the Food and Drug Administration approved azithromycin to treat infections caused by susceptible sensitive organisms. The approval made it possible for doctors to prescribe the medication to treat:

  • Mycobacterial infections
  • Lower and Upper Respiratory Tract Infections including tonsillitis, pharyngitis, sinusitis, bronchitis, chronic bronchitis, and mildly severe community-acquired
  • Genital ulcer disease (Chancroid)
  • soft tissue and skin infection including impetigo, erythema migrans (Lyme’s disease), secondary pyoderma, and erysipelas (bacterial skin infection)

By 1991, Pfizer, Inc. began marketing azithromycin under their brand name Zithromax. Doctors typically administer the medication as an oral suspension, capsule, ophthalmic solution, intravenous injection, and film-coded tablet.

Worldwide, Zithromax (azithromycin) is sold under numerous names including fluconazole, tinidazole, ambroxol, nimesulide, and cefixime.

Who Should Not Take Zithromax?

The antibacterial antibiotic is highly effective at killing off harmful bacteria known to cause serious problems. However, there are certain contraindications that could cause adverse reactions in serious side effects to certain people taking the medication. Usually, these individuals are suffering from some type of associated medical condition, are experiencing and allergic reaction, or currently taking a contraindicating drug concomitantly with Zithromax (azithromycin). Patients should avoid taking Zithromax or the generic form azithromycin if:

  • They are allergic to the medication, any other macrolide antibiotic, or any of its ingredients.
  • They are currently taking migraine medications including ergotamine or dihydroergotamine, or
  • They are currently taking anti-reflex medication (cisapride).

In addition, the drug should not be taken concomitantly with bromocriptine, cabergoline, and pergolide. Because the medication is formulated with lactose, the patient should avoid taking Zithromax if they suffer from glucose malabsorption, lactase deficiency, or galactosemia. Individuals with a history of appellate dysfunction or cholestatic jaundice should also not used the product.

Zithromax Side Effects

All over-the-counter drugs and prescription medications have some form of side effect or adverse reaction, including Zithromax (azithromycin). The mild side effects experienced by patients taking Zithromax or its generic version azithromycin include:

  • Hearing issues
  • Tendinitis (ringing in the ears)
  • Abdominal pain
  • Itching or rash
  • Vaginal discharge or itching
  • Insomnia (difficulty sleeping)
  • Nervous feeling
  • Mild headache
  • Lethargy or tired feeling
  • Dizziness
  • Stomach upset or pain
  • Constipation, vomiting, or mild diarrhea
  • Diminished smell
  • Diminished taste

Some patients experienced an allergic reaction when taking Zithromax (azithromycin). It is essential to stop taking the medication and seek immediate medical help if serious side effects occur, including:

  • Severe skin reaction
  • Swelling of the tongue or face
  • Burning eyes
  • Upper stomach pain
  • Dark urine
  • Jaundice (yellowing of the eyes or skin)
  • Clay-colored stools
  • Pounding or fast heartbeat
  • Fainting
  • Severe dizziness
  • Chest pain

Zithromax and Pregnancy

The active ingredient of Zithromax, azithromycin, is known to pass through mother’s milk when breastfeeding. The FDA warns that doctor should only prescribe azithromycin when clearly needed. If the mother has been taking Zithromax or its generic version and is breastfeeding at the same time, the breastfed newborn should be routinely monitored to look for fungal infections, sensitization, diarrhea, or another gastrointestinal side effect.

Newborns that have been exposed to azithromycin during their first three months of life might be at an increased risk of up to 350 times greater than normal and developing infantile hypertrophic pyloric stenosis – where the opening between the small intestine and stomach thickens.

Zithromax and Streptococcal Pharyngitis

Strep throat is a common and painful infection of the tonsils and throat that can cause various symptoms including swollen glands, sore throat, loss of appetite, fever, and white spots on the tonsils. This condition is often a bacterial assault on the body and can usually be effectively treated using a strong antibiotic. Some doctors prescribe a Zithromax Z-Pak to minimize the spread of infection to others and shorten the length of time the patient suffers common symptoms associated with strep throat. However, this type of antibiotic is not usually the first choice for combating the infection.

Zithromax and Urinary Tract Infections

Doctors usually do not prescribe Zithromax (azithromycin) to treat urinary tract infections, urethra inflammation (gonorrheal negonoreyny urethritis), or cervix inflammation (cervicitis). However, a Zithromax Z-Pak can help. Typically, the doctor will recommend using Macrodantin, Bactrim, Cipro, or amoxicillin instead.

Azithromycin-Related QT Interval Prolongation Symptoms

The Food and Drug Administration is concerned about potential azithromycin-cardiovascular side effects in individuals suffering from QT interval prolongation when the heartbeat becomes irregular. The potentially fatal condition can display a variety of symptoms including:

  • Fainting
  • Palpitations
  • Ventricular fibrillation
  • Cardiac arrest
  • Death

The Link between Kidney Failure and Zithromax

Millions of individuals in the United States takes Zithromax, a popular antibiotic to treat various infections. However, the medication is known to cause serious side effects including kidney failure. The symptoms often involve drowsiness, decreased urine production, vomiting, and coma. Doctors worried that their patients are suffering a heart-related issue, allergic reaction or kidney related problem. When taking Zithromax can look for noticeable signs and indicators and include:

  • Acute kidney failure
  • Kidney disease
  • Interstitial the fried us
  • The body’s failure to produce urine
  • Decreased levels of urination
  • Abnormal kidney blood test showing increased levels of creatinine
  • Abnormal kidney blood tests with increased BUN level

Other related symptoms of kidney failure when taking Zithromax (azithromycin) include a sore throat, headache, fever, skin peeling, severe blistering, or red skin rash.

Lawsuits

2013 – The FDA issued a national warning to consumers through a Safety Communication revealing that Zithromax (azithromycin) “can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.” The agency also made claims that individuals that have known risk factors for heart disease have a greater potential risk of developing serious heart problems including those with existing Q-T prolonged intervals, and patients with low potassium or magnesium levels.

Others at risk include those suffering from arrhythmias, slow heart rate, and patients currently taking abnormal heart rhythm medication process. The FDA advises healthcare professionals to consider the benefits of using Zithromax compared to the fatal heart rhythms it may increase an individual’s potential risk of experiencing a cardiovascular event.

2012 – A report published in the New England Journal of Medicine revealed increased potential of experiencing a cardiovascular death in individuals taking azithromycin products compared to patients taking Cipro (ciprofloxacin), amoxicillin and levofloxacin (Levaquin). Individuals at highest risk are those that were also at risk for any type of heart disease

The FDA warned consumers that there was already a known risk of heart problems in all micro-light antibiotics, including Zithromax. The FDA said drugs linked to prolong Q-T intervals can cause potentially fatal abnormal heart rhythms.

Zithromax Lawsuits

Many plaintiffs have filed suit against Pfizer, for marketing Zithromax as a safe and effective antibiotic. Unfortunately, one study in the New England Journal of Medicine and another in a Vanderbilt University publication concluded that patients taking Z-Paks had a greater potential risk of losing their life from a cardiac event compared to other patients taking other forms of antibiotics. Information concerning Zithromax lawsuits includes:

  • Taking Zithromax Likely the Cause of a Child Severe InjuriesDecember 2014 – Pfizer and its subsidiary Greenstone are facing one more Zithromax lawsuit, this time filed by a Florida resident who alleges the drug caused her child to suffer symptoms of Stevens-Johnson syndrome, a serious life-threatening allergic reaction. Drs. prescribed the plaintiff Zithromax in 2009. Within a proximally 2 weeks after first taking Zithromax, the child developed Stevens-Johnson syndrome where lesions of the mucous membranes and skin quickly became burns and painful blisters placing the young child at risk of dying.

    Lawsuit documents reveal that the plaintiffs are accusing Pfizer of failing to provide adequate warning to them, their doctors, other consumers, and the medical community that Zithromax could cause Stevens-Johnson syndrome. The mother claims that had she known of the dangerous risks of taking the medication, she would have never given consent to her child’s physician to use Zithromax.

    Lawyers working on her behalf also allege that the drug maker failed to conduct adequate studies and testing on their medication and instead marketed an unsafe medication in the medical marketplace.

  • Is Pfizer Overselling Their Popular Antibiotics Zithromax?October 2014 – Pfizer Inc., makers of Zithromax, received a warning letter from the US Food and Drug Administration who claims that the pharmaceutical company is over promoting their antibiotic and failing to provide adequate safety warnings. The FDA referred to a Pfizer brochure marketing Zithromax noting that the drug company was making unsubstantiated claims. The letter warns Pfizer that they are “seriously downplaying” the known side effects of their antibiotic medication and their failure to inform any potential patient of how serious the known reactions and adverse events can be.

    The FDA’s accusing Pfizer of overselling the benefits of taking this popular antibiotic and makes claims that the drug can treat a wide variety of infections that have yet been approved by the federal agency. The FDA is also warning Pfizer to stop making “unsubstantiated superiority claims when telling consumers that their antibiotic works significantly better than the competitors. The letter was more than just a warning. The FDA demands that the company take numerous corrective actions including pulling the brochure from their marketing campaign.

    The FDA also noted that Zithromax has been linked to numerous severe side effects including heart attacks, liver damage, and SJS (Stevens-Johnson syndrome). The federal agency also said that Pfizer must warn any potential client of the known Zithromax side effects in their marketing campaigns and advertisements.

Let Us Handle Your Zithromax Lawsuit

The Zithromax injury attorneys at the Drug Law Center are currently investigating, evaluating, and reviewing compensation lawsuits on behalf of our clients who have suffered serious life-threatening complications after taking the antibiotic. We pursue all monetary compensation claims and financial lawsuits through contingency fee agreements. This means we postpone our attorney fees until we obtain your recovery through a negotiated out-of-court settlement or a jury trial award.

Contact us today for a potential Zithromax lawsuit consultation at no charge to you. All information you share with our law offices will remain confidential.

 

Sources:

http://www.nejm.org/doi/full/10.1056/NEJMoa1003833

http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2553295

http://www.mayoclinic.org/drugs-supplements/azithromycin-oral-route/description/drg-20072362

https://www.fda.gov/Drugs/DrugSafety/ucm341822.htm

https://health.clevelandclinic.org/2013/04/fda-issues-warning-for-popular-antibiotic/

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf

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