Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Celebrex Is Found to Be No Riskier for Hearts Than Other Pain Drugs, But Still Risky!

Celebrex Is Found to Be No Riskier for Hearts Than Other Pain Drugs, But Still Risky! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The drugs seemed miraculous when they were introduced in 1999, and they soon became blockbusters, with billion-dollar sales. Vioxx, made by Merck, and Celebrex, made by Pfizer, could quell pain and inflammation just as well as drugs like ibuprofen and naproxen, but they did not cause ulcers and gastrointestinal bleeding.

 

But then, the shocker. A Merck clinical trial asking if Vioxx could also prevent colon cancer revealed that the drug increased the risk of heart attacks, and the company pulled it off the market in 2004. Ever since, a question has hung over Celebrex. Did it cause heart attacks, too?

 

A decade ago, the Food and Drug Administration asked Pfizer to find out. Now, at long last, the resulting clinical trial is done. Most medical researchers, including the study’s principal investigator, thought Celebrex would be riskier than either ibuprofen or naproxen. Instead, it was at least no worse and may even be safer than the alternatives.

 

“This is definitely a striking finding,” said Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was not associated with the study.

 

An estimated two million people in the United States take Celebrex or generic celecoxib, said Dr. Milton Pressler, a cardiologist in charge of clinical affairs for Pfizer Essential Health. The drug is available only by prescription; as the trial dragged on its patent expired, so now generic companies also sell it.

 

The study involved 24,000 people with arthritis who were at high risk for heart disease or already had it. A third of them were randomly assigned to take Celebrex, a third to take naproxen and a third to take ibuprofen. The doses were equivalent and neither the participants nor the investigators knew who was taking what.

 

The results were published online in the New England Journal of Medicine on Sunday to coincide with a presentation at the annual meeting of the American Heart Association by Dr. Steven Nissen of the Cleveland Clinic, who directed the new study.

 

He and others emphasized that the findings apply only to people taking the drugs every day for months or years and who are at high risk for heart disease or already have it. They do not apply to someone who pops an occasional ibuprofen like Advil for a pulled muscle or takes a naproxen such as Aleve for a headache.

Pharma Guy's insight:

The original headline of this article - "Celebrex Is Found to Be No Riskier for Hearts Than Other Pain Drugs" is misleading. All NSAIDs are risky according to the FDA. Read “FDA Warns of Increased Chance of Heart Attack or Stroke Caused by NSAIDs - No Exceptions!”; http://sco.lt/5sv7JJ

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FDA Warns of Increased Chance of Heart Attack or Stroke Caused by NSAIDs - No Exceptions!

FDA Warns of Increased Chance of Heart Attack or Stroke Caused by NSAIDs - No Exceptions! | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.


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.


Pharma Guy's insight:


In a 2007 COX-2 Health Advisory, FDA said: "FDA has concluded that the benefits of Celebrex outweigh the potential risks in properly selected and informed patients." I don't see FDA mentioning that in this safety alert.

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