- House Passes Bill to Improve Safety of Drugs Made by Compounding Pharmacies
- FDA Warns That Antibiotic Tygacil Shows Raised Death Risk
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
House Passes Bill to Improve Safety of Drugs Made by Compounding Pharmacies
A bill meant to improve the safety of customized drugs prepared by compounding pharmacies was passed Saturday by the U.S. House of Representatives.
The legislation would improve how drugs made by compounding pharmacies are tracked from production until they're sold at a drug store, and require the Food and Drug Administration to coordinate its safety oversight of the drugs with states, the Associated Press reported.
Compounding pharmacies could voluntarily register as outsourcing facilities, which would place them under FDA authority. Those that remain traditional pharmacies would continue to be watched over mostly by state pharmacy boards.
The Senate is preparing similar legislation.
About a year ago, a meningitis outbreak that killed 64 people and sickened hundreds of others was traced to a compounding pharmacy in Framingham, Mass., the AP reported.
FDA Warns That Antibiotic Tygacil Shows Raised Death Risk
The antibiotic Tygacil is linked to an increased chance of death when used to treat serious infections, the U.S. Food and Drug Administration said Friday.
In issuing a black box warning, the agency asked that physicians limit their use of the intravenous medication.
Labeling for the Pfizer drug will now state that the medicine "should be reserved for use in situations when alternative treatments aren't suitable."
The warning is based on a new analysis that showed 2.5 percent of patients receiving Tygacil died, compared with 1.8 percent of patients receiving other antibiotics.
Pfizer said in a statement it will update the labeling, Dow Jones reported. "Pfizer encourages health care professionals to review all available information to find an antibiotic therapy that works best for each patient's clinical situation," the company said.
Approved for the treatment of a specific type of pneumonia and certain skin and intra-abdominal infections, Tygacil is not approved to treat diabetic foot infections or for hospital-acquired or ventilator-associated pneumonia. In 2012, sales of the drug surpassed $335 million, Dow Jones reported.
The agency's concerns with Tygacil first surfaced in 2010, when the FDA warned of an increased risk of death in clinical studies. Since then, the agency has analyzed data from 10 trials to arrive at the decision to issue a black box warning.
"In general, the deaths resulted from worsening infections, complications of infection or other underlying medical conditions," the agency said.
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