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FDA strengthens warning that non-aspirin NSAIDs can cause heart attacks or strokes

By |October 27, 2015|NSAIDs|

Source FDA

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on their comprehensive review of new safety information, they are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. They will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Based on their review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:

  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.
  • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
  • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  • There is an increased risk of heart failure with NSAID use.

Steps Set for Livestock Antibiotic Ban

By |March 24, 2012|Public Health|

Source NY Times

The Obama administration must warn drug makers that the government may soon ban agricultural uses of some popular antibiotics that many scientists say encourage the proliferation of dangerous infections and imperil public health, a federal magistrate judge ruled on Thursday.

The order, issued by Judge Theodore H. Katz of the Southern District of New York, effectively restarts a process that the Food and Drug Administration began 35 years ago, but never completed, intended to prevent penicillin and tetracycline, widely used antibiotics, from losing their effectiveness in humans because of their bulk use in animal feed to promote growth in chickens, pigs and cattle.

The order comes two months after the Obama administration announced restrictions on agricultural uses of cephalosporins, a critical class of antibiotics that includes drugs like Cefzil and Keflex, which are commonly used to treat pneumonia, strep throat and skin and urinary tract infections.

Siobhan DeLancey, an F.D.A. spokeswoman, would not say whether the government planned to appeal. “We are studying the opinion and considering appropriate next steps,” she said.

In a separate move, the F.D.A. is expected to issue draft rules within days that ask drug makers to voluntarily end the use of antibiotics in animals without the oversight of a veterinarian. (more…)