Tag Archives: FDA Warning Letters

U.S. Food and Drug Administration Advises Serious Side Effects Associated With Fluoroquinolone Antibacterial Medication

FDAbanner

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.


The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.  For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options. 

The new FDA ruling calling for restricted use of fluoroquinolones affects five prescription antibiotics: ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive). All are also available as generics.

https://cdifffoundation.org/2016/05/05/a-study-provides-data-that-between-2010-and-2011-throughout-u-s-at-least-30-percent-of-antibiotics-unnecessarily-prescribed/

 

ANTIBIOTIC STEWARDSHIP PROGRAM UPDATES:

https://cdifffoundation.org/2016/04/29/antibiotic-stewardship-program-and-updates-from-sources-cdc-pew-charitable-trusts-with-idsa-and-shea-guidelines/

 

For Additional Information Regarding This Topic – Please Visit The Following Consumer Article:

http://www.consumerreports.org/drugs/fluoroquinolones-are-too-risky-for-common-infections/

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together.  These side effects can involve the tendons, muscles, joints, nerves, and central nervous system. 

As a result, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.  We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine.   Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.  Patients should talk with your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.  

Fluoroquinolone drugs work by killing or stopping the growth of bacteria that can cause illness.

We previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008.  The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015. 

We urge patients and health care professionals to report side effects involving fluoroquinolone antibacterial drugs and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

For more information, please visit: Fluoroquinolone.

 

FDA Issues Warning Letters To Three U.S. Dairy Farms And Two Food Importers

 

FOOD SAFETY NOTICE:

Three U.S. dairy farms and two food importers were on the receiving end of warning letters recently from the Food and Drug Administration.

The warning letters to the dairy farms cited animal drug violations involving antibiotics. The warnings to food companies in French Polynesia and Sri Lanka that import fish and juice to the U.S. concerned violations of food safety regulations related to hazard analysis and control programs.

William W. Van Norstrand, owner of the Vansridge Dairy in Scipio Center, N.Y., was warned about the sale of an animal for food that had illegal drug residue. FDA referenced the August 2015 sale and slaughter of a dairy cow that showed penicillin residue in kidney tissue of 0.058 parts per million (ppm) in analysis by the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS). The FDA’s established tolerance lever is 0.05 ppm in uncooked, edible tissues of cattle.

406x250FDA-WARNING

The FDA warning letter said: “The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated …”

 

 

 

Another FDA warning letter went to the five managing partners of the Legacy Ranch #2 in Tulare, Calif., also over animal drug issues.

Dairy cows at the ranch received injections of sterile penicillin G procaine that did not follow the ranch veterinarian’s directions for use with regard to dosages per injection site and failure to meet the minimum withdrawal period before slaughter, according to the warning letter. The “extricable use” of the antibiotic was not under the supervision of a licensed veterinarian, the letter from the FDA’s San Francisco district office said.

 

The Hawk Dairy Farm in Minerva, Ohio, was the third dairy farm to receive a warning letter, also regarding penicillin residue.

In March 2015 the farm sold a dairy cow for slaughter as food. The FSIS analysis of kidney tissue samples collected from the animal showed the presence of penicillin at 0.363 ppm, which is in excess of the federal 0.05 ppm tolerance level.

In addition, FDA said the Hawk Dairy holds “animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.”

In warning letters to S.A.R.L. Pacific Tuna in French Polynesia, and to Target Agriculture in Sri Lanka, the FDA told the companies the United States will likely refuse admission to their products unless they quickly adopt the agency’s advice about Hazard Analysis and Critical Control Point (HACCP) regulations.

In the warning letters, FDA gives Pacific Tuna lengthy and specific instructions on how to comply with seafood HACCP regulations. The agency gives similar details instruction to Target Agriculture on juice HACCPs.

 

Resource:

http://www.foodsafetynews.com/2016/01/fda-issues-warnings-to-3-dairy-farms-2-food-importers/#.Vp5A71Ji9Qt