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Article Summary: Recent Evidence Suggests That Cox 2s May Elevate The Risk Of Heart
Recent Evidence Suggests That Cox 2s May Elevate The Risk Of Heart Attack And Stroke
With the Food and Drug Administration set to hold hearings next week on the safety of popular painkillers like Bextra and Celebrex, a U.S. Senator is charging that the agency is preventing one of its scientists from presenting results from the largest and most recent study of heart risks posed by the drugs.
The study, which was co-written by FDA scientist David Graham, a longtime critic of the medications that belong to a class of drugs called cox-2 inhibitors, is based on a large California Medicaid database to reveal heart risks posed by a wide range of painkillers. Cox-2 drugs include Bextra, Celebrex and Vioxx, the Boston Globe reported.
This would mark the third time in recent months that the FDA had been accused by Congress of ignoring research by its own scientists. In each case, the research was later confirmed by other scientists, the newspaper said.
In a letter to the FDA, Sen. Charles Grassley, an Iowa Republican, asked why the agency failed to make a review of the California study a priority, 'given the urgent regulatory and drug safety issues."
The letter, sent Friday night to FDA acting commissioner Lester Crawford, demanded a formal reply no later than Wednesday, the day the FDA hearings are scheduled to begin, the newspaper said.
The FDA did not immediately respond to requests for comment, the Globe said.
The hearings were prompted by Merck & Co.'s decision last September to pull Vioxx from the market after research showed long-term use of the drug increased the risk of heart attack and stoke.
Although originally introduced as a better alternative to traditional nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen and naproxen -- all of which increase the risk of gastrointestinal bleeding -- recent evidence suggests that cox-2s may elevate the risk of heart attack and stroke.
Malaria Drug Prompts Concern Among Some U.S. Troops in Iraq
U.S. military officials have stopped giving an anti-malaria drug called Lariam (mefloquine) to troops in Iraq following claims by some current and former soldiers that the medication causes disturbing, even dangerous behavior. Relatives of some troops contend the drug caused the suicides of their loved ones, the Associated Press reported.
Claims of the drug's side effects are largely anecdotal. The U.S. military, which developed the drug after the Vietnam War, insists Lariam is safe, although officials have expressed some concern and the military tells its pilots not to take Lariam, the AP said.
Last year, the Pentagon urged commanders to request a medical evaluation of anyone who showed behavioral changes after taking the drug, "especially... if they carry a weapon" -- which nearly all U.S. troops in Iraq do, the news service said.
The drug's manufacturer, Roche Pharmaceuticals of Nutley, N.J., notes that more than 30 million people worldwide have used Lariam over two decades. "There is no reliable scientific evidence that Lariam is associated with violent acts or criminal conduct," Roche spokesman Terence Hurley wrote to the AP in an e-mailed response to questions.
The company does warn, however, of rare but severe side effects, including paranoia and hallucinations, the news service said.
Lariam is among the drugs recommended by the U.S. Centers for Disease Control and Prevention for treatment and prevention of malaria, which kills an estimated 1 million people worldwide each year, the AP said. If you or anyone you know has taken BEXTRA and has experienced the above symptoms or side effects, contact our BEXTRA lawyer and receive a free case evaluation.
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