A 16 Year Old's Story as written by her sister

The Story of A Child Levaquin Victim

In March of 2000, my little sister, who was 16 years old, developed difficulty hearing in her right ear.  Her ear, nose, and throat specialist ordered a CAT scan.  The radiologist told her ENT doctor that she had a sinus infection.  Apparently the ENT specialist didn’t bother to read the CAT scan and he concurred with the radiologist.  We later found out after consultation with another doctor that a wisdom tooth had punctured the large right sinus cavity--and she never had an infection, and this fact should have been obvious to the radiologist and the ENT if he had actually read the CAT scan. 

Despite the misdiagnosis, this would not have been a problem if the ENT had prescribed a safe antibiotic for my sister.  Instead, he prescribed 500 mg of Levaquin (levofloxacin, a fluoroquinolone antibacterial) once a day.  He did this despite the numerous pediatric warnings that are clearly stated in bold and large font in the Physician’s Desk Reference.  According to Ortho-MacNeil, the maker of Levaquin, Levaquin is not supposed to be prescribed to anyone under the age of eighteen.  The prescription was filled at a local Walgreens pharmacy, which provides Medi-Spam Corporation’s package inserts for patients.  For some reason, Medi-Spam did not put the pediatric warning on their profiles even though the company that Osco uses does.  Consequently, my family was not told by my sister’s doctors or the pharmacy that this medication was dangerous to children. 

            After my sister took the fifth pill, it was as if a bomb went off in her body.  She collapsed at school and had to be half carried out of the building to my mother and me.  She said every joint in her body ached; she was dizzy and her skin was raw with a rash.  Her right wrist was red and swollen.  My mother called the doctor.  He refused to talk to her, but instead had the nurse tell my mother that my sister was having a “little allergic reaction” to the Levaquin and to give her a lot of water and Benadryl--which we did.  The next day, my sister could not get out of bed.  All of her joints ached and she was in so much pain she was curled up in the fetal position.  She cried out when we opened the shade in her bedroom.  She could not tolerate any light because she said it seemed as if someone was shining a high-powered spotlight in her face every time she opened her eyes.  She had a terrible headache, the rash persisted, she was sick to her stomach and her hands shook so much that it was difficult for her to hold a glass of water.  My mother kept calling the doctor and he refused to talk to her.  After several calls, his nurse hollered at my mother and said:  “I told you the doctor said it would take a couple of days for the medication to get out of her body.”  The nurse then called in a prescription for Biaxin, which my mother had told the ENT my sister could take safely.  But it was too late. 

            Since the doctor was refusing to help, I turned to the Internet to see if anyone else had reported the same symptoms as my sister.  As it turned out, it is not just children who have experienced the strange mix of symptoms that my sister experienced.  We were shocked to find out that Levaquin (and indeed, all fluoroquinolones) has a questionable safety record for people of all ages.  Seven fluoroquinolones have been pulled off the market in the United States because of severe adverse drug reactions like my sister’s, and many more have been pulled from worldwide markets, or their use has been restricted to life-or-death situations because of severe adverse drug reactions, including death due to heart and renal failure.  Levaquin has not yet been pulled from the market, but because of my sister’s symptoms and the experiences of the other tens of thousands of people who I found out experienced the same symptoms, I believe it should be. 

            There was now no doubt in our minds that my sister was not experiencing a mere allergic reaction.  Allergic reactions are transient occurrences, but her symptoms showed no signs of clearing up, and in fact, they were worsening by the day.  Within days of her initial symptoms, her Achilles tendons and rotator cuffs were at the point of rupturing.  We had to rush her to the emergency room.  The emergency room doctor looked at her chart and said:  “who and the hell is the moron who prescribed this medication?  It is never supposed to be given to anyone under the age of 18.”  The doctor went on to say that anytime someone of any age came to the emergency room with an unexplained tendon problem, she always asked if they had been prescribed a fluoroquinolone antibacterial, and she found that quite often, they had been.

My sister was now in a boot cast and a sling in a desperate attempt to stabilize her tendons by immobilizing them.  She could not tolerate natural or artificial light.  She began to experience other nervous system symptoms, such as anxiety, hallucinogenic dreams, and, most frighteningly, a sudden, unexplained compulsion to commit suicide.  Please know that my sister had never experienced any psychiatric or psychological disturbances in her life, but that fluoroquinolones are known to induce psychological side effects, and suicide is now finally listed as a possible side effect of fluoroquinolone use.  In the weeks that followed, my family took my sister to a series of doctors who ruled out arthritis, lupus, MS and a host of other diseases.  It always came back to the fact that she was fine before she took the Levaquin. 

When we realized that no doctor in Illinois could help her we took her to Georgetown University to see a man named Dr. David Flockhart.  He said she had had a severe adverse drug reaction to Levaquin and that it should never be prescribed to anyone under the age of 18, although he had seen many adult patients who experienced the same thing my sister did.  He said there is no cure for her condition--that the medication had penetrated her bones, her tendons, her muscles and her nerves.  Levaquin is a negatively-charged particle that tends to bind to positively-charged calcium and magnesium found in the bones and other soft tissues.  He also said the Levaquin had blocked the GABA receptors in her brain, causing the vision disturbances, tremors, rashes, and psychological effects.  He said it would take five to six years for this medication to “grow” out of her body and then she would be left with the damage it had done to her bones, nerves, and soft tissues. 

        We began to deal with the fact that our lives were going to be changed forever.  My sister went from being a healthy, active, extremely artistic 16-year-old whose talent has helped her community and whose artwork has won awards to a teenager who couldn’t even lift a gallon of milk because of the pain in her hands and shoulders and the threat of rotator cuff rupture.  She went from being a proficient martial artist who was one step away from a black belt in Tae Kwon Do to a teenager forced to use a wheelchair because her knees and ankles hurt so badly because the cartilage and tendons could spontaneously rupture at any moment.  She went from being a happy-go-lucky teenager with fourteen years of experience playing the piano to a world-weary young adult who learned all too well the challenges faced by people with disabilities.

      Those who have experienced even mild adverse drug reactions to fluoroquinolones often attest that they experience periods of lesser symptoms followed by periods of more severe symptoms.  This cycling has occurred in my sister, as well.  For weeks and even months at a time, she has been unable to perform even the simplest functions, such as carrying schoolbooks or walking to class because of pain, swelling, and threat of tendon rupture in her limbs.   She has experienced spontaneous tearing of the cartilage in her ribcage, including an unprovoked rupture while in her wheelchair on the way to one of her high school classes.  For the initial four months of the adverse drug reaction, she had to wear black sunglasses to block out all light because she was so sensitive to light.  Her vision returned to normal, but then some time later, she lost her peripheral vision.  It returned a few months later.  Sometimes her symptoms are localized to areas of her body like her arms or feet, and sometimes they affect her entire body.

It has been four years now.  My sister has been in 29 orthopedic casts for her arms and legs in order to prevent tendon ruptures.  Her hands still shake.  Periodically her vision is affected.  Pain is now a daily factor in her life--as she says, it’s not a question of when she is in pain, it is a question of how much pain she’s in every day.  Typically, changes in the barometric pressure influence how much pain she’s in.  She is our “walking weather person” because the pain becomes horrible for her when the weather changes.  Periodically the tendinitis in her peroneal tendons and Achilles tendons flare up so badly that she cannot walk.  The tendons in her arms, wrists, hands, fingers and shoulders still flare up, limiting her ability to do common, daily tasks such as writing and typing.   There are still days when the pain is so great she cannot get out of bed.

She has to use a wheelchair scooter on her college campus because she cannot walk long distances.  She cannot open doors for herself and can only attend classes in buildings that are accessible not only in that they have elevators and ramps but buttons to open doors as well.  During her freshman year, the plantar facia in her right foot ruptured while she was sleeping.  The cartilage in her right knee began to flake off, which causes immense pain.  She was my maid of honor in my wedding last year, but we were afraid up until the last minute that she would not be able to attend because her doctor raised the possibility of needing emergency surgery.  As it was, she had to wear a full-leg cast on her leg under her dress and had surgery not long after my wedding. 

What is most devastating, however, is that my sister is and has always been a talented artist.  When she was a small child, she figured out how to draw three-dimensional objects on her own.  Her artwork has won awards both in and out of school since she was in grammar school.  Her work was used by the Roselle police office for its DARE program when she was eleven years old.  Her animation has been used by the College of DuPage as a teaching tool since she was twelve.  She began designing logos and artwork for area companies and schools in junior high and continues even today, as much as she is able to.  She has consistently been described by every art teacher she has ever had as being a creative genius.  Levaquin has stolen away her ability to use her God-given talents in career and volunteer activities.  She can only draw for a few minutes or an hour a day, and even then she experiences pain when she does so.  She had planned to be an animation artist since she saw her first Disney cartoon.  Now, her dreams have been shattered.  Her artwork is no less brilliant, but she simply cannot use her gifts to the extent that she otherwise would have been able to. 

As you can tell, Levaquin has devastated my sister’s life.  It has taken away her health, her career, and her ability to have a normal life.  In fact, our whole family has been devastated by this senseless tragedy.  My family was never warned that Levaquin could do this.  Indeed, most doctors are not aware of the devastating, permanent adverse drug reactions caused by Levaquin and other fluoroquinolones, or if they know, they do not understand the seriousness of the situation.  Some, like my sister’s ENT, flatly refuse to acknowledge the possibility of adverse drug reactions at all, despite overwhelming evidence to the contrary.   The fact that the warnings required by the Food and Drug Administration are not adequate and do not acknowledge the severity and permanence of the adverse drug reactions does not help. 

            My mother has talked to the FDA numerous times.  The last time, a woman in Sally Singer’s office said to my mother:  “there are so many angry people out there because of Levaquin.  Some day we are going to have to do something about this drug.”  When my mother asked when, she refused to answer my mother.  The British have given Levaquin the Black Triangle--the equivalent of saying that a drug is under investigation to possibly be pulled from the market because of the severity of adverse drug reactions.  Why has the FDA not placed Levaquin and other fluoroquinolones under such scrutiny?

            On behalf of my sister, my mother is one of the tens of thousands who have filed adverse drug reaction reports with the FDA, yet she has never once received a phone call or email to follow up with her.  No one at the FDA seems to be concerned that a child has had the rest of her life ruined because of a few pills.  

              The FDA and the drug companies feel that side effects like my sister’s are not considered “serious” because she is not dead.  It doesn’t matter that my sister and all of the other fluoroquinolone victims have had their lives ruined and are forced to live in constant pain.

Last Updated 1/01/05