Vioxx Risks
Heart Attacks
The recent study out of the Cleveland Institute, which appeared in the Aug. 22 issue of The Journal of the American Medical Association, concluded that Vioxx doubled the risk for heart attacks. The Cleveland Clinic noted an increase in the development of myocardial infarctions, or heart attacks, in people treated with Vioxx, when compared with those treated with naproxen (a standard NSAID).
While not everyone taking Vioxx is at a high risk for heart attack, the study raises significant questions regarding its safety for patients with high blood pressure, in poor shape, etc. The study goes on to caution doctors to use the drugs carefully, especially in people with heart disease.
It is, as yet, not clear whether the increased risk of heart attack is due to a property of Cox-2 inhibitors (this includes both Vioxx and Celebrex), or is a property unique to Vioxx.
The recent link between heart attacks and Cox-2 inhibitors has prompted the Food and Drug Administration to consider whether they should require manufacturers of Cox-2 inhibitors to strengthen the label to include a warning about the potential risk for cardiovascular problems. Contact us for more Vioxx lawsuit information.
Cox-2 Inhibitors
NSAIDs (non steroidal anti-inflammatory drugs) like aspirin or ibuprofen work to relieve pain by blocking two enzymes in the body, Cox-1 and Cox-2. These enzymes help to regulate normal cell function in the stomach and blood. While blocking the Cox-2 inhibitor is good (it plays a part in causing inflammation and arthritis pain), NSAIDs also block the Cox-1 enzyme that helps protect the lining of the stomach.
Cox-2 inhibitors inhibit only the Cox-2 enzyme, which plays a role in inflammation of body tissue. These drugs do not seem to block the Cox-1 enzyme that helps protect the lining of the stomach. Cox-2 inhibitors, in theory at least, do not cause the gastrointestinal problem that have been associated with NSAIDs.
Cox-2 inhibitors have their downsides as well though, especially for individuals who suffer from heart problems. The heightened risk of heart attack associated with Cox-2 inhibitors may be due to the fact that the Cox-1 enzyme helps in preventing blood clots that can certainly contribute to heart problems.
Which is better for you? NSAIDs such as aspirin and nonsteroidal drugs that inhibit the Cox-1 enzyme probably protect people from developing heart attacks, whereas, Cox-2 inhibitors don't protect people from developing heart attacks but do help stem gastrointestinal problems. Talk with your physician or healthcare professional about which is right for you.
Deaths Linked to Celebrex
Celebrex has not been without its own concerns. During 1999, the year that
the drug was released onto the market, it was linked to 10 deaths in the first
months that it became available. The story first ran in the Wall Street Journal
from research obtained from the Food and Drug Administration. Two of the deaths
were caused by heart attacks, one from a poor interaction with another drug,
one from kidney problems, one death listed no specific cause of death, and
half of them were attributed to gastrointestinal bleeding.
During the initial period of release onto the market, there were also 11 cases
of gastrointestinal hemorrhaging associated with Celebrex. The story passed
and Celebrex was not deemed responsible for the complications or deaths. However,
the recent study that linked Vioxx to an increased risk of heart attack, is
certainly a warning flag for Celebrex as well.
Danger in a Name?
Celebrex has received less than stellar press for the errors and complications
due to the similarity between its name and that to the drugs Celexa and Cereryx,
a medications used to treat depression and an intravenous drug for epilepsy,
respectively. 50 reports have been submitted to the FDA about this confusion.
The confusion over the names have not led to any serious medical problems.
Half of the cases were reports detailing the confusion over the name, 19 were
prescription written for the wrong drug but caught before the patient took
the drug, and the remainder involved individuals actually taking the wrong
drug. Contact us for more Vioxx lawsuit information.
Experts Weigh in on Vioxx and Celebrex
Some experts question whether Celebrex and Vioxx are better pain relievers
that NSAIDs. Most agree that Cox-2 inhibitors are easier on the gastrointestinal
system than NSAIDs. The manufacturers have petitioned the FDA to allow
them to label the drugs as safer on the stomach, but the FDA was not
convinced. Their petitions did, however, raise concerns about cardiovascular
problems associated with Cox-2 inhibitors.
The conclusion of FDA medical officer Maria Lourdes Villalba was that Vioxx
should continue to carry the same warning as other NSAIDs regarding gastrointestinal
(GI) problems like ulcers, bleeding and perforation. Villalba also noted that
the risk of heart attack and stroke should be added to the label.
Cox-2 inhibitors are Big Business
The pharmaceutical giant Merck manufactures Vioxx, while Pfizer and Pharmacia manufacture and market Celebrex. These Cox-2 inhibitors are significant moneymakers for these large pharmaceutical companies. The recent report of possible health risks may hurt their sales. Since the drugs have been available in 1999, Celebrex and Vioxx are now generating yearly combined sales of $6 billion. The fact that the manufacturers have denied the report findings is certainly not surprising given the drugs standing as important cash cows.
If You Take Vioxx
If you take Vioxx, talk with your doctor or healthcare professional (nurse, nurse practitioner, physician assistant, pharmacist, etc.) about whether the drug is right for you. Physicians should be aware of the health risks associated with these Cox-2 inhibitors. Always voice any questions and concerns you may have regarding the safety issues over these drugs. Know which warning signs to be aware of. Your physician may recommend you take a low dose of aspirin along with the Cox-2 inhibitor in order to lower the risk of heart attack.
For more information on Vioxx warnings,
contact us to speak with a Vioxx Lawyer