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FOX25 Investigates: Some blame certain antibiotics for devastating side effects

Millions of people take antibiotics to get better, but a certain group of the drugs comes with serious side effect warnings.

FOX25 investigates concerns those warnings are not strong enough for the doctors prescribing the drugs. 
FLUOROQUINOLONES
These kind of antibiotics are called "fluoroquinolones."  They're prescribed for a number of serious bacterial infections.  Some of the more well-known generics include Ciprofloxacin and Levofloxacin, and the brand name examples include Cipro and Levaquin.
A NORMAL LIFE TURNS INTO A NIGHTMARE
Betsy Hamill was a vibrant healthy mother of three boys when she was prescribed an antibiotic for a sinus infection. She thought nothing of it.
Betsy says she took Ciprofloxacin in 2007 for a sinus infection and had a severe reaction. She felt pressure in her head and couldn’t walk without holding onto something for balance. She also started having speech issues.  Betsy thought that once she stopped taking the antibiotic that she would be fine. She was wrong.
The long term impact was devastating.  
"I took two pills when I went to bed then the next one first thing in the morning.  I said to my husband, I feel worse not better. I had all these different health issues I did not connect them together as possibly being from one medication.  I have joint pain and tendon issues.  I also had neurological issues.," she said.
Doctors told Betsy her brain was not communicating correctly with her muscles.  She once enjoyed camping, jogging, skiing and she is now on disability and has a handicap placard.  Betsy says she wasn't well informed about the serious side effects of the antibiotic, but hopes others will use what she's gone through to protect themselves.
PUSH FOR CHANGE
There are warnings on these antibiotics, but the FDA is now being urged to make sure doctors are more aware of how serious the side effects are before prescribing these drugs.
Dr. Charles Bennett runs one of the biggest pharmaceutical safety programs in the country. He says many people are ending up with serious issues from fluoroquinolones, like Cipro and Levaquin.  Bennett said his group gathered "thousands" of stories from people who reported these side effects from those drugs:  
- Muscle weakness
- Heart disease
- Hearing loss
- Depression
- Nerve damage
- Death
Click here for more information on the warnings. 
Bennett says these antibiotics can be very effective and doesn't want them banned.  He is pushing the federal government to do more to warn patients about possible side effects. Bennett is petitioning the FDA to require even stronger warnings on these drugs. 

Click here for the petitions.

FDA RESPONSE
"We are not able to discuss the specific issues raised in the petition at this time because the FDA does not discuss specific matters that are still pending before it.  However, we can assure you that the FDA takes concerns raised about safety of approved drugs very seriously and we are considering the matters raised by the petition and giving it our careful attention. We will respond directly to the petitioner and post our response online after we review."
CIPRO STATEMENT

"Patient safety is our first priority at Bayer.  We care deeply about patients and take the safety of our medicines very seriously. Cipro (ciprofloxacin) has been in the U.S. market since 1987, with extensive clinical experience and a proven safety profile, and is to be used in accordance with the label, which includes a description of its respective approved indications and appropriate mode of administration, as well as contraindications, adverse reactions, interactions, warnings and precautions.  Bayer maintains accurate product labels that share information about the benefits and risks associated with Cipro use.  We report all adverse events we learn about to the U.S. Food and Drug Administration (FDA) and actively monitor such reports including ones raised in the Citizen's Petition."  - Bayer Corporation

LEVAQUIN STATEMENT

"Our first priority is the well-being of the people who use our medicines.  We are aware of the citizen petition and are evaluating it. LEVAQUIN (levofloxacin) is part of the important fluoroquinolone class of anti-infective prescription medications that have been used for more than 20 years to treat infections, including those that may be serious or life threatening. All medicines, including LEVAQUIN, have both benefits and risks. We continually collect and monitor information on the safety and effectiveness of all our medicines, and, in cooperation with the US FDA and other health authorities, we incorporate new data into our product labels so doctors and patients can make informed decisions.  Ever since it was first approved by the FDA in 1996, the LEVAQUIN label has provided information to physicians on the risks and benefits associated with the medication, including warnings and precautions.  Since 2004, the LEVAQUIN label has informed physicians and patients about possible side effects related to peripheral neuropathy. "

You can find the current LEVAQUIN® Medication Guide for patients here:
The full U.S. prescribing information, including boxed warning, here.
PUBLIC'S VOICE TO BE HEARD
The FDA will be holding a public joint advisory committee on fluoroquinolones on Nov. 5. Specifically, the committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions. 

For more information, click here.

CONSUMER ADVICE
If you have negative side effects from antibiotics, tell your doctor.  If you feel the warnings should be stricter, contact a lawmaker.

Cox Media Group

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