FDA Advice For Doctors About Nerve Damage From Antibiotics

Today's post from topclassactions.com (see link below) is the latest article warning of the dangers of nerve damage from fluoroquinolone antibiotics. This time the warning comes from the FDA themselves. Last year they instructed the pharmaceutical companies to put warning labels on the boxes of these drugs and now they are advising doctors who prescribe these antibiotics, to be especially alert to symptoms of nerve damage in their patients (at which point of course, it could be too late). There's no doubt that this has been the hot topic in neuropathy circles for some time now but with good reason. If your doctor prescribes antibiotics for you, ask him or her if they belong to the fluoroquinolone group and if they do, don't leave the surgery until you have had a serious discussion as to whether they're going to harm you or not. There are alternatives but successful marketing campaigns have made these drugs the most popular antibiotics around. However, if you're prone to neuropathic problems or have them already you really need to question their value for you.

FDA Advises Doctors to Monitor Antibiotic Users for Nerve Damage 
By Amanda Antell January 13, 2015

Due to the mass concern of fluoroquinolone side effects, the FDA recently announced that it wants healthcare professionals to watch for the risk of peripheral neuropathy in patients prescribed these antibiotics.

As of Aug. 15, 2013, fluoroquinolones had become a major concern for the FDA for a number of reasons, but this particular warning surrounded the devastating side effect peripheral neuropathy, which can cause nerve damage, burning pain, paralysis and more.

The agency advises prescribing physicians to closely monitor patients who are prescribed any members of the fluoroquinolone family, which include the antibiotics levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).

In its announcement, the FDA reiterated its requirement for manufacturing companies to have their medications’ labels include peripheral neuropathy on their list of side effects, and emphasized the danger with a recent toll of injuries. If not diagnosed in time, this condition can cause severe to permanent damage.

According the FDA’s Center for Drug Evaluation and Research Trade press team, the agency made the decision to update the warning for fluoroquinolone peripheral neuropathy due to the number of injury reports the agency had received. While the agency decided against withdrawing fluoroquinolones from the market, the FDA did revise its systemic benefit and risk evaluations regarding these antibiotics.

A recent review of the FDA’s Adverse Event Reporting System (AERS) Database had identified 83 cases of fluoroquinolone peripheral neuropathy between Jan. 01, 2003 and Aug. 01, 2012; this was the report discussed in the Aug. 15, 2013 FDA warning. Each of these patients had become disabled due to some degree of antibiotic nerve damage, which furthered the FDA’s concern of this possible correlation.

Antibiotic Nerve Damage a Concern for Years

The concern of peripheral neuropathy being associated with fluoroquinolones started in 2004, when the FDA required all fluoroquinolones to carry this risk on their list of side effects.

While the complication of antibiotic nerve damage is a frightening thought, it’s the fact that the injury reports indicate that the condition could start within a few days of starting the medication, and continue for years after stopping it, that has many so concerned. Even in 2015, the FDA and other medical institutes have not managed to identify what exactly causes peripheral neuropathy from antibiotics, but it appears not to be related to age or duration of medication use.

Additionally, during their August 2013 warning, FDA MedWatch stated that physicians should give patients a medication guide for every fluoroquinolone prescription, and patients should be instructed to contact their physicians if they show signs of peripheral neuropathy. While suddenly ceasing medication is not advisable without a physician’s consultation, the FDA generally recommends that the medication should be switched with a non-fluoroquinolone antibiotic, unless the risks of the new antibiotic outweigh the benefits.

Medical experts state that a majority of peripheral neuropathy reports indicate that it is not linked with diabetes, thyroid conditions, vitamin deficiencies, or environmental factors. It is important to note that the risk of peripheral neuropathy is still a relatively recent concern, but remains prevalent because there are no known prevention methods.

Overview of Quinolone Peripheral Neuropathy

Fluoroquinolones are among the most popularly prescribed antibiotics in the United States, and are used to treat a variety of bacterial infections. In 2011, over 23 million patients were prescribed a member from this antibiotic family to treat their conditions. As mentioned before, peripheral neuropathy has been listed as a side effect for fluoroquinolones since 2004, with patients reporting long-lasting or permanent disability, allegedly in direct consequence of using this medication.

Peripheral neuropathy is a condition where the nerves that send signals from the brain and spinal cord become damaged, which disrupts communication with the rest of the body. Symptoms of peripheral neuropathy will vary depending on which nerves are affected. Generally speaking, the symptoms are in the arms and legs and include numbness, tingling, burning, or shooting pain.

It is important to note that peripheral neuropathy symptoms start quickly, and spread just as fast, so it is vital that patients see their physicians immediately.

 http://topclassactions.com/lawsuit-settlements/lawsuit-news/47255-fluoroquinolone-peripheral-neuropathy/