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FDA: Add arrhythmia risk warning on azithromycin

March 18, 2013 5:28am
The Philippine Food and Drug Administration has advised doctors and manufacturers of the dangers of the antibiotic azithromycin, amid recent findings it can potentially cause arrhythmia or irregular heartbeats.

In an advisory posted online early Sunday, the FDA said such a condition may be triggered by “drug interactions” and may be prevented by avoiding certain medicines in a patient’s regimen.

“Azithromycin is an antimicrobial medicine which is life-saving for serious bacterial infection. Due to Pharmacovigilance post-marketing surveillance from the US FDA, a significant adverse reaction was found and hence additional warning was mandatorily added to this specific product information,” it said.

For now, the FDA said it is sending “Dear Doctor” letters to advise physicians on this new finding. The letters remind doctors of “their responsibility to further advise patients needing this drug.”

It is also holding discussions with the concerned industry to “place additional new warnings in their product label.”

Health professionals, patients and establishments are encouraged to report adverse drug reactions.

These reports may be sent to the ADR unit of the FDA Philippines at Civic Drive, Filinvest Estate, Alabang, Muntinlupa, or may be faxed to (02) 807-85-11 to the ADR unit.

The reports may also be emailed to ccdiza@fda.gov.ph or mamkabiling@fda.gov.ph.

No adverse drug reaction so far

The FDA noted that in the Philippines, there are 60 companies carrying this medicine, with 72 registered brands.

MIMS.com, a website offering "officially approved" drug information to medical professionals in the Asia Pacific, said at least 21 brands of azithromycin are available in the Philippines.

These include:
  • Aza-500
  • Azi-500
  • Azin
  • Azithro-Natrapharm
  • Azomycin
  • Aztro
  • Azyth
  • Decantin
  • Endure Medical Azithromycin
  • Geozit
  • Macromax
  • Macrozyth
  • OD Mac
  • Pediazith
  • Sitimax
  • Thromaxin
  • Trozin
  • Zenith
  • Zenith Suspension
  • Zithromax
  • Zmax One Dose


So far, the FDA said the local drug safety monitoring showed incident of an adverse drug reaction.

“While the adverse reaction is serious, the incidence is rare at (greater than) 1 in 10,000 to less than 1 in 1000,” it said.

An article on TheFilipinoDoctor.com said a prescription is needed for azithromycin. — DVM, GMA News



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