Tag Archives: Fluoroquinolones

Quick Hits: FDA Approves New Antibiotic, ADHD Med, and Opioid Use in Depressed Patients

The FDA has approved Baxdela (delafloxacin), a fluoroquinolone antibiotic that is used to treat acute bacterial skin and skin structure infections (ABSSSI). The drug is available as a tablet or intravenous injection. Labeling for the drug includes a “black box” warning due to serious adverse and potentially irreversible reactions that have been associated with fluoroquinolones, such as tendinitis and tendon rupture, peripheral neuropathy and central nervous system effects. In trials, the most common adverse reactions in patients observed were nausea, diarrhea, headache, elevations of the enzyme transaminase, which can indicate liver damage, and vomiting. Posted June 19, 2017. Via Melinta Therapeutics.

A new once-daily treatment for attention deficit/hyperactivity disorder (ADHD) has won FDA approval. Mydayis, a stimulant for patients 13 years and older, contains the same active ingredients as Adderall (amphetamine/dextroamphetamine), but lasts for up to 16 hours compared to up to 6 for Adderall and 12 for Adderall XR. Adderall and Adderall XR are both available as a generic. Like other stimulant medications, such as methylphenidate (Ritalin, Concerta, Daytrana), Mydayis has a “black box” warning because it has a high chance for abuse and can cause physical and psychological dependence. Posted June 20, 2017. Via Shire.

Patients with low back pain who also suffer from depression are more likely to be given opioids that are prescribed at higher doses. This is problematic, since patients with depression are at a higher risk of misuse and overdose of opioids. Researchers examined data on opioid prescriptions from 2004-2009 and found that those with low back pain who also had depression were twice as likely to be prescribed an opioid than those without depression. And over a year, they typically got more than twice the usual dose, according to the study published in the journal Pain Reports. The authors noted more study is needed to determine the risks and benefits of prescribing such powerful painkillers to those who are depressed. Posted June 20, 2017. Via University of Rochester Medical Center.

Some Antibiotics Linked to Miscarriage Risk

Some antibiotics may be associated with a higher risk of miscarriage in early pregnancy.

Researchers at the University of Montreal looked at data on about 96,000 pregnancies that ended in miscarriage. Of that number, about 8,700 women took an antibiotic during pregnancies.

Some classes of antibiotics, such as fluoroquinolones, macrolides and tetracyclines were associated with an increased risk of miscarriage before the 20th week of pregnancy, the researcher reported in the Canadian Medical Association Journal.

The antibiotics on the list – such as Zithromax (azithromycin) and Cipro (ciprofloxacin) — are used to treat a wide range of infections, such as urinary tract infections and respiratory infections.

“Our study found that penicillins and cephalosporins are not associated with risk of spontaneous abortion,” lead study author Anick Bérard, PhD, told ABC News. “Similarly, we found no risk with erythromycin and nitrofurantoin. These are some of the most-used drugs used to treat UTIs, so our study shows that they are real treatment options.”

Antibiotic Ear Drops May Pose Eardrum Risk

Antibiotic ear drops commonly prescribed to children after ear tube surgery may increase risk for perforated eardrums.

The antibiotics in question are known as quinolones. Researchers looked at data on more than 100,000 children that had ear tube surgery and found that those treated with quinolone ear drops after the procedure were 60% more likely to experience perforated eardrums compared to those who received neomycin drops, another type of antibiotic.

Also, the risk may be higher if steroids are given in addition to the quinolone drops, the researchers reported in the journal Clinical Infectious Diseases.

This is not the first time quinolones have come under fire. Last year, the FDA warned that fluoroquinolones – which account for most of the quinolones prescribed – should be limited due to a risk of potentially permanent side effects.

Quick Hits: FDA Limits Use of Antibiotics Class, Misusing Rx Drugs & More

Use of a common class of antibiotics should be limited due to a risk of potentially permanent side effects. The FDA has approved safety labeling changes for fluoroquinolones given that an agency safety review found that both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. These side effects can happen hours to weeks after the drug is taken. Common fluoroquinolones include Levaquin (levofloxacin), Cipro (ciprofloxacin), Avelox (moxifloxacin), Floxin (ofloxacin) and Factive (gemifloxacin). The new labeling also limits fluoroquinolones to patients who are unable to take other antibiotics for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections. Posted July 26, 2016. Via FDA.

Half of Americans may be misusing their prescription medications by taking other drugs that could lead to drug-drug interactions, according to a new report from Quest Diagnostics. The lab test company analyzed more than 3.1 million results from lab specimens collected between 2011 and 2015. Quest found that last year, 54% of the specimens indicated misuse of prescription drugs, mostly as a result of taking other drugs either non-prescribed or illicit. The figure was 53% in 2014 and 63% in 2011. Results also showed that 28.6% of samples that tested positive for heroin also tested positive for benzodiazepines. Most troubling was that benzodiazepines were not prescribed in 90% of these cases. Benzos were found to be the most popular drug that led to “inconsistent” test results among all age groups, followed by opioids. Posted July 27, 2016. Via Quest Diagnostics.

The FDA has approved a new once-daily injection to treat type 2 diabetes. Adlyxin (lixisenatide) is known as a glucagon-like peptide-1 (GLP-1) receptor agonist. Other approved drugs in this class include Byetta (exenatide), Victoza (liraglutide) and Trulicity (dulaglutide). Adlyxin’s safety and effectiveness was demonstrated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In addition, patients at risk for atherosclerotic cardiovascular disease treated with Adlyxin did not have an increased risk of cardiovascular adverse events. The most common side effects seen with Adlyxin were nausea, vomiting, headache, diarrhea and dizziness. Hypoglycemia was also evident in some patients treated with both Adlyxin and other antidiabetic drugs. Posted July 28, 2016. Via FDA.

Quick Hits: Amputation Risk With Diabetes Med, & More

People taking the diabetes medication Invokana may be at risk for leg and foot amputations. The FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in the amputations, mostly affecting the toes, in patients taking Invokana (canagliflozin). The FDA has not determined whether the drug increases the amputation risk, but is currently investigating the issue and will update the public when they have more information. Posted May 18, 2016. Via FDA.

The use of benzodiazepines is tied to adverse drug events and increased mortality, according to a study published in the Journal of General Internal Medicine. Researchers from Harvard Medical School aimed to determine whether prescribing of benzodiazepines, anti-anxiety drugs, was associated with risk factors for adverse effects. Of the 65,912 patients in the study, clinicians prescribed at least 1 benzodiazepine to 15%, of which 5% of those received high doses. Those who received benzodiazepines were more likely to be diagnosed with depression, substance abuse, tobacco use and osteoporosis, among others. Posted May 17, 2016. Via MPR.

British researchers will investigate the risk of muscle pain associated with statins thanks to a £1 million ($1.46 million) grant from the UK government. The trial, funded by the National Institute of Health Research, comes after doctors have warned that the side effects of the drugs, which include severe muscle pain, depression, fatigue, diabetes and impaired memory and stroke, outweigh the benefits in some patients. The London School of Hygiene and Tropical Medicine will coordinate the study and will enroll 200 patients who have stopped or want to stop using statins due to muscle pain or fatigue. They will also assess whether muscle problems are more common in statin users than those taking a placebo. Posted May 15, 2016. Via The Express.

Fluoroquinolones, a class of antibiotics, are associated with disabling and potentially permanent serious side effects that can occur together when used systemically (via tablet, capsule or injection), according to the FDA. These side effects can impact tendons, muscles, joints, nerves and the central nervous system. While fluroquinolones are usually prescribed to treat acute sinusitis, acute bronchitis and uncomplicated urinary tract infections who have other treatment options, the FDA suggests that other antibiotics be used except in cases where there are no other treatment options. The FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs, such as Avelox (moxifloxacin), Cipro (ciprofloxacin) and Levaquin (levofloxacin) to be updated to reflect this new safety information. Posted May 12, 2016. Via FDA.

Many people on anti-psychotic drugs are not properly informed about their side effects, which can lead to serious consequences, according to a British charity. A poll conducted by Rethink Mental Illness found that 62% of those who are on, or caring for someone on, anti-psychotic medication said the risks, benefits and side effects were not adequately explained to them. Also, half of the 200 people polled said they had not received a physical health check before their medication was prescribed. Posted May 17, 2016. Via BT.

The Pros & Cons of Probiotics

Antibiotics are the drug of choice when it comes to fighting bacterial infections — but they’re not without their side effects, some of them serious. Without them, infections such as strep or tuberculosis can cause organ damage, even death. But while they’re destroying the bad bacteria that’s making us sick, they’re also doing a number on the beneficial bacteria that normally live in our gastrointestinal tract. That disruption of our gut flora causes gastrointestinal complications ranging from mild to moderate AAD (antibiotic-associated diarrhea) to the diarrheal infection known as C. difficile (Clostridium difficile).

There’s nothing good about those side effects. But are antibiotics’ “alter ego” — probiotics — the miracle cure many make them made out to be?

What Are Probiotics?

Probiotics are live, beneficial microorganisms, either bacteria or yeast-based, and there’s been a lot of attention paid lately to their purported ability to restore a healthy microbial balance in our GI tract. The research to date appears promising, with several recent meta-analyses — weighted reviews of previous studies — pointing to the efficacy of probiotics, particularly when it comes to preventing AAD. Most of the evaluated studies used a lactobacillus probiotic alone or in combination with another probiotic. The most studied, and commonly recommended, probiotic supplement for the prevention of AAD is Lactobacillus GG (Culturelle).

A 2015 Cochrane review of studies of the effectiveness of probiotic treatment in children shows a statistically significant reduction in AAD. In a study of adults given commercially-available probiotic-containing drinks such as Actimel or Danone (a beverage of Lactobacillus casei, Lactobacillus bulgaricus, and Streptococcus thermophilus), during antibiotic treatment and for a week afterwards significantly decreased their risk of developing diarrhea.

Some researchers contend that while these meta-analyses appear positive, the evaluated studies themselves were small, methodologically flawed or statistically insignificant. At least one recent large study has disproven the use of probiotics in AAD prevention: In older patients, a 2013 clinical trial known as PLACIDE found that among 17,420 hospitalized patients age 65 and older, being treated with probiotics showed no significant decrease in AAD rates. They also were at an increased risk of side effects such as flatus — gas in the stomach or intestines — and bloating.

If you experience these symptoms, proponents of probiotics recommend you lower the dose to allow your body to adjust to the changing, hopefully healthier, gut environment. Be aware, too, that because probiotics are supplements, they aren’t approved or regulated by the FDA. There’s no way to know whether the probiotic you’re taking actually contains the strains and dosing stated on the package. As live organisms, there’s also potential risk of contamination.

According to Sonia Ballal, MD, a pediatric gastroenterologist with Boston Children’s Hospital, the evidence is good that probiotic treatment is especially helpful in treating AAD in children (whereas there’s less evidence for adults). “All in all, it’s the early days of probiotics, but there appears to be a benefit when it comes to preventing antibiotic-associated diarrhea in children,” she says. “As the research continues, eventually we’ll be able to pinpoint which strain of probiotic to use for which indication.”

Despite this modest good news, there’s currently no consensus among doctors or researchers to recommend probiotic supplements across the board as a preventive for either AAD or C. difficile. In fact, probiotic use remains a hotly debated topic in gastrointestinal medicine, with expert practitioners on both sides of the argument. In November 2015, the American Gastroenterological Association ran editorials on the positive as well as the negative side of the use of probiotics.

No Harm… Maybe?

By and large it appears that probiotics aren’t harmful and could be help prevent antibiotic-associated diarrhea, says Ann Ouyang, MD, professor of medicine in the division of gastroenterology and hepatology at Penn State Hershey Medical Center. “The microbiome is really important in our gastrointestinal health and probiotics will change the microbiome,” she explains.

However, she adds, much more research needs to be done to determine the overall long-term effects of probiotics. “Some probiotics may carry some antibiotic-resistant genes, so it’s not risk free. It’s not a panacea,” she says.

The verdict on probiotic use in AAD and C. difficile is still out, with health organizations each interpreting the data in different ways. The Natural Medicines Comprehensive Database rates effectiveness of dietary supplements based on scientific evidence on the following scale: Effective, Likely Effective, Possibly Effective, Possibly Ineffective, Likely Ineffective, Ineffective, and Insufficient Evidence to Rate. Lactobacillus is rated as “possibly effective” for preventing AAD in children and in hospitalized adults.

Meanwhile, the Mayo Clinic evidence scale on supplements rates Lactobacillus acidophilus a “C” meaning there’s “unclear scientific evidence for this use” when it comes to diarrhea prevention and treatment.

As of now, probiotics aren’t included in any standard of care guidelines to treat either condition, says Christina Surawicz, MD, MACG, who authored the latest standard of care guidelines for diagnosing, treating and preventing C. difficile for the American College of Gastroenterology. Probiotic use is not part of the standard of care guidelines for C. difficile.

“The data is pretty good that they prevent antibiotic-associated diarrhea, with Lactobacillus GG (Culturelle) and Saccharomyces boulardii (Florastor), but there’s not enough evidence to recommend the use of probiotics to prevent C. difficile infections,” says Dr. Surawicz, professor of medicine at the University of Washington School of Medicine in Seattle.

While antibiotics aren’t to blame for all C. difficile infections — other risk factors include old age and being immune compromised — broad spectrum antibiotics such as flouroquinolones, cephalosporins, clindamycin, and penicillins are most likely to lead to a C. difficile infection. In order to prevent C. difficile, Surawicz recommends making sure antibiotics are only taken when needed, and when necessary, using the most narrow-spectrum antibiotic possible.

Who Shouldn’t Take Probiotics?

In December 2014, the FDA issued a warning (pdf) to health care providers against the use of dietary supplements containing live bacteria or yeast in patients who are immunocompromised, citing the death of a premature infant who developed gastrointestinal mucormycosis after receiving an in-hospital treatment of ABC Dophilus Powder (Solgar) that was tainted with the mold Rhizopus oryzae. If you have a compromised immune systems, take immunosuppressant drugs, or who have a venous catheter, you may be at a greater risk of becoming seriously ill from the live bacteria or yeast found in probiotic supplements, says Dr. Surawicz.

Probiotics may also pose a risk for those with certain allergies, such as to gluten. Researchers at the Celiac Disease Center at Columbia University Medical Center found that 12 of the top 22 top-selling probiotics had detectable traces of gluten, even though more than half of the 22 were labeled as gluten-free.

Saccharomyces boulardii (Florastor), the second-most widely studied probiotic for use in AAD and C. difficile, is a live yeast-based probiotic. Patients sensitive to yeast should talk to their doctor before taking this probiotic.

Alternatives to Probiotics for AAD

The obvious alternative to probiotic supplements is fermented foods which contain healthy bacteria. Dr. Ballal recommends yogurt with live and active cultures to her pediatric patients. Dr. Surawicz recommends kefir, a fermented milk product that contains live bacteria and yeast, to her adult patients. Kefir may cause constipation and cramping, and is not recommended for use in children younger than 1 year of age.

If you experience mild to moderate diarrhea while on antibiotics, try changing your eating habits until the symptoms pass. Experts recommend avoiding any fatty or fried foods, which can further loosen your stool. Increase your intake of clear fluids, preferably drinking 8 to 10 glass of water daily, to combat dehydration. Doctors often suggest the BRAT diet, which stands for Bananas, Rice, Applesauce and Toast. Eating more soluble fiber or taking a fiber supplement, such as Metamucil, may be recommended to help bulk up your stool. Be careful to add the fiber slowly or you may also experience gas and bloating from adding too much, too soon.

Another good post-antibiotic move: Up your intake of foods that naturally contain probiotics, such as the previously mentioned kefir, but also fresh sauerkraut, kombucha, tempeh, kimchi. In short, make a point to invite lots of the good guys to your gut.

Further Reading:

Drugs in Pregnancy Part 4: Antibiotics

In Part 4 of our 7-part Drugs in Pregnancy series, we tackle antibiotics. If you’re wondering whether taking an antibiotic is a good idea or harmful to your baby, the answer is a resounding … it depends. It depends on the infection at hand, for one thing; most must be treated, as not doing so would cause more harm to you than it would pose a threat to your baby. And it depends on the drug itself: There are many types of antibiotics, some considered safe, some no-no’s.

For more on pregnancy and drugs, see parts 1 through 3 in our series, and check out our Drug  Classification of Prescriptions Medicines During Pregnancy. And always ask your doctor or other healthcare provider what course of treatment is best for you and your baby.

Bacterial Infections

Unfortunately, bacterial infections wait for no one. You don’t want to leave any infection untreated and, used wisely, antibiotics effectively kill the harmful bacteria and associated infection. The majority of commonly prescribed antibiotics don’t have any known risks to the pregnancy, says Lori Wolfe, a certified genetic counselor and president of MotherToBaby, a free, national informational service of the nonprofit Organization of Teratology Information Specialists.

Some 10% to 15% of pregnant women develop urinary tract infections, which could cause premature labor and pyelonephritis, a bacterial infection in the kidneys. Amoxicillin, amoxicillin-clavulanate, and cephalexin are the antibiotics used for UTIs with the least risk to the fetus. Studies suggest avoiding sulfonamides, which may be prescribed for UTI during pregnancy, and nitrofurantoins, which have been associated with several birth defects.

Fluoroquinolones, including the commonly prescribed ciprofloxacin (Cipro), are often used for UTIs in the general population, but should be avoided during pregnancy — and probably entirely. In recent years the FDA has issued several black-box warnings on fluoroquinolones and their risk for permanent nerve damage and tendon damage and rupture to the primary user. The FDA has issued warnings on other fluoroquinolones to avoid.

To prevent UTIs, wipe from front to back after using the bathroom to avoid spreading fecal bacteria to your vagina, take showers instead of baths, and ask your doctor about a probiotic that promotes good gut bacteria. As for cranberries, there’s conflicting evidence of whether drinking cranberry juice or taking cranberry supplements actually prevents UTIs.

A common infection, Group B Streptococcus, or GBS, is present in the vaginas and/or rectums of about 25% of pregnant women. If untreated, it can cause serious complications for pregnant women, such as cystitis, amnionitis, endometritis, and stillbirth, and occasionally, endocarditis or meningitis, and life-threatening infections in the newborn. The CDC recommends all pregnant woman are screened for GBS at around 37 weeks gestation, as it’s often asymptomatic. GBS is usually treated at time of delivery with IV penicillin or ampicillin.

Drugs to Avoid

Some antibiotics should be avoided during pregnancy. These include tetracycline and doxycycline, which if used during weeks 16 through 40 can deposit in the baby’s developing teeth and bone, resulting in staining to their permanent teeth. This has been known for several decades, so most doctors usually don’t prescribe these antibiotics to pregnant women. A few other antibiotics are considered ototoxic, meaning there’s a risk of hearing loss to the mother, but these are not among those commonly prescribed.

New research by Columbia University’s Mailman School of Public Health found that prenatal antibiotic use puts offspring at an 84% higher risk of obesity later in life, compared with children who were not exposed to antibiotics in utero. This study adds to previous ones that have shown that antibiotic use given early in a child’s life may be associated with an increased risk of obesity in childhood. Researchers believe that the antibiotics may enter fetal circulation via the placenta, affecting the normal transmission of healthy bacteria from the mother to child.

To keep the bacterial levels in a healthy balance, and to avoid side effects such as diarrhea or constipation, take a probiotic simultaneously, though at different times in the day. Ask your doctor which probiotic makes the most sense for you.

Further Reading