Drug Safety Developments

FDA Panel Seeks Tougher Antibiotic Labels

Quoted from http://www.wsj.com/articles/fda-panel-seeks-tougher-antibiotic-labels-1446784061

FDA Panel Seeks Tougher Antibiotic Labels

Mounting evidence of previously unknown, and sometimes permanent, side effects prompted review

By Thomas M. Burton
Nov. 5, 2015 11:27 p.m. ET

SILVER SPRING, Md.—A Food and Drug Administration advisory panel overwhelmingly called for heightened label warnings on widely prescribed antibiotics called fluoroquinolones because of unusual but sometimes devastating side effects.

The action followed a day of emotional testimony from dozens of patients who said these drugs have had a wide range of harmful effects on their health and cognitive ability.

The agency decided earlier this year to have its advisory committee examine the class of antibiotics because of mounting evidence of previously unknown, and sometimes permanent, side effects.

Panel member Dr. Tobias Gerhard, professor in the Department of Pharmacy Practice at Rutgers University, said the panel voted for the stronger label warnings “because of the remarkable testimony that we have heard today.”

The drugs are commonly prescribed, with a total of more than 36 million prescriptions issued in 2014, according to drug-research firm IMS Health.The panel was examining the drugs for their safety when used to treat sinus infections, urinary-tract infections and bronchitis that worsens existing chronic obstructive pulmonary disease.

The panel was asked to consider whether the current labels adequately explain the benefits and risks for the three conditions and, if not, whether the labels should be revised. The vote for revising labels was 21-0 on sinusitis; 18-2, with one abstention, on bronchitis; and 20-1 regarding urinary-tract infections.

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Study Clears Certain Antibiotics of Serious Eye Risk

Quoted from http://www.newsday.com/news/health/study-clears-certain-antibiotics-of-serious-eye-risk-1.6501795

Study Clears Certain Antibiotics of Serious Eye Risk

Published: November 26, 2013 4:35 PM
From HealthDay
By Robert Preidt

Cipro and other drugs in the same class of antibiotics don't appear to raise the risk of an eye problem called retinal detachment, according to a new study that contradicts previous research.

Retinal detachment -- separation of the retina from its connection to the back of the eye -- can cause vision loss. A group of researchers recently concluded that use of antibiotics called fluoroquinolones was associated with a significantly increased risk of retinal detachment. This new study challenges that finding.

The latest investigation involved an analysis of data from millions of people in Denmark. Of nearly 600 people diagnosed with retinal detachment, 72 had used fluoroquinolones. Most had taken Cipro (ciprofloxacin), while others had used ofloxacin (Floxin, Ocuflox), fleroxacin (Quinodis and Megalocin) or moxifloxacin (Moxeza, Avelox, Vigamox).

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Popular Antibiotics May Carry Serious Side Effects

Quoted from http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/

Popular Antibiotics May Carry Serious Side Effects

By JANE E. BRODY

September 10, 2012

Antibiotics are important drugs, often restoring health and even saving lives. But like all drugs, they can have unwanted and serious side effects, some of which may not become apparent until many thousands of patients have been treated.

Such is the case with an important class of antibiotics known as fluoroquinolones. The best known are Cipro (ciprofloxacin), Levaquin (levofloxacin) and Avelox (moxifloxacin). In 2010, Levaquin was the best-selling antibiotic in the United States.

But by last year it was also the subject of more than 2,000 lawsuits from patients who had suffered severe reactions after taking it.

Part of the problem is that fluoroquinolones are often inappropriately prescribed. Instead of being reserved for use against serious, perhaps life-threatening bacterial infections like hospital-acquired pneumonia, these antibiotics are frequently prescribed for sinusitis, bronchitis, earaches and other ailments that may resolve on their own or can be treated with less potent drugs or nondrug remedies — or are caused by viruses, which are not susceptible to antibiotics.

In an interview, Mahyar Etminan, a pharmacological epidemiologist at the University of British Columbia, said the drugs were overused “by lazy doctors who are trying to kill a fly with an automatic weapon.”

Dr. Etminan directed a study published in April in The Journal of the American Medical Association showing that the risk of suffering a potentially blinding retinal detachment was nearly fivefold higher among current users of fluoroquinolones, compared with nonusers. In another study submitted for publication, he documented a significantly increased risk of acute kidney failure among users of these drugs.

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Drugs most frequently reported for adverse reactions

Quoted from http://www.philly.com/philly/blogs/healthcare/157042255.html

Drugs most frequently reported for adverse reactions

by Michael R. Cohen, R.Ph.

You may be surprised to learn that in 2011, the Food and Drug Administration received 179,855 reports of serious or fatal adverse drug reactions. This was an increase of 15,386 reports (9.4 percent) from the 2010 total. Reports reached the FDA through two mechanisms. Voluntary reports from health professionals and consumers and reports from manufacturers. There were 21, 002 voluntary reports and 158,853 from manufacturers. Manufacturers must report serious events within 15 days of becoming aware.

The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. Keep in mind that this is not a scientific study of the frequency of adverse drug events in clinical practice. These are the medications that health professionals and consumers told the FDA were causing serious and fatal side effects during 2011. It is interesting to note that just two of these drugs were first introduced in the last decade (Pradaxa and Cymbalta), and only one in the previous year (Pradaxa), suggesting that major drug safety issues are not confined to recently approved drugs.

Pradaxa surpassed all other monitored drugs in several categories, including overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291), and stroke (644). It was also suspect in 15 cases of liver failure. Coumadin has been prominent in the rankings for many years. It accounted for 1,106 reported ADEs overall, including 731 reports of hemorrhage and 72 deaths.

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