CELEBREX® Side Effects
Did you know?
Celebrex was the first of Pharmacia's COX-2 inhibitors.
CELEBREX® Side Effects: Deaths Linked to CELEBREX®
While the recent report linked heart attacks specifically to Vioxx®, this does not mean that CELEBREX® is not without its risks as well. Several years ago when the drug initially came to market, The Wall Street Journal ran a story that spread throughout the media linking CELEBREX® to 10 deaths during its first three months. In addition, there were eleven other cases of gastrointestinal hemorrhage associated with the drug. The Wall Street Journal obtained the information from the FDA's Freedom of Information Act. Of the ten deaths, half of them were from ulcers (also known as gastrointestinal bleeding). Two of the deaths occurred from heart attack, one to a kidney problem, one to an interaction with another drug, and no cause was given for the other death. While nothing came of this story (i.e. CELEBREX® was not deemed responsible for the deaths), the recent revelations bring to life once again the potential dangers associated with Cox-2 inhibitors.
The association between Cox-2 inhibitors and health concerns has prompted the Food and Drug Administration (FDA) to consider adding warning labels to Vioxx® and CELEBREX® about the potential risk of cardiovascular problems.
Cox-2 Inhibitors CELEBREX® Side Effects
Cox-2 inhibitors inhibit the enzyme involved in inflammation of body tissue. Traditional NSAIDs inhibit both the Cox-1 and Cox-2 enzymes. The problem with this is that they stop the "good" Cox-1 enzyme that helps protect the lining of the stomach. Cox-2 inhibitors, in theory at least, do not impair the good Cox-1 enzyme, only the Cox-2 enzyme that is responsible for inflammation. Cox-2 inhibitors therefore cause less gastrointestinal problems.
However, Cox-2 inhibitors are not without their problems. They increase the risk of heart attack. The reason for this may be a simple difference between what enzymes are inhibited in the platelets by these drugs. One theory for this holds that the Cox-1 enzyme plays a role in preventing clot formation that leads to heart problems.
So aspirin and other 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.
The Effectiveness of CELEBREX®
Many experts in the field are not convinced that CELEBREX® or Vioxx® are more effective for pain relief than traditional nonsteroidal drugs (NSAIDS). There does seem to be substantial evidence that both drugs are safer in regards to gastrointestinal side effects, like ulcer, gastrointestinal bleeding or obstructions. However, the manufacturers of the drugs were unable to convince the FDA to allow them to market the drugs as being safer on the stomach than other NSAIDS. The only thing the companies managed to do was to raise concerns about the risk they posed to consumers with regards to cardiovascular problems.
Clinical trials that led to the approval of CELEBREX® and Vioxx® suggested that the drugs were safer on the stomach. But the manufacturers had to conduct longer-term studies to drop a warning about serious ulcers that all NSAIDs carry. 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.
Furthermore, Vioxx® and CELEBREX® do not do anything whatsoever to treat osteoarthritis, they simply treat the pain. Glucosamine on the other hand is completely safe and has been shown to be beneficial in the treatment of the disease by rehabilitating cartilage through the production of proteoglycans and glycosaminoglycans.
What to do if you are currently taking CELEBREX®?
The most important step for patients currently taking Vioxx® or CELEBREX® is to discuss their health and history with their physician. Your doctor is hopefully aware of the potential health risks associated with these Cox-2 inhibitors and may advise using low-dose aspirin or some other alternative in order to minimize the risk of heart disease from these drugs. Patients must educate themselves on the potential risks, and if they experience any side effects associated with Cox-2 inhibitors, they need to immediately contact their doctor.
FDA Warning – Celebrex
Too early to draw conclusions about CELEBREX® safety
- Five of the 10 people who died suffered from gastrointestinal bleeding or ulcers. Of the other deaths, two were attributed to heart attacks, one to drug interaction, one to a kidney disorder--and a fifth cause remains undetermined.
"It's too early to reach any conclusions about the drug's safety," an FDA spokesman tells CNN.
The deaths and complications figured in the FDA's adverse-events report, which is filed quarterly. Reports of problems are provided by pharmaceutical companies, doctors and patients.
"There is no indication these deaths and complications were caused by the use of CELEBREX®," says Scarlett Foster, a spokesperson for Searle & Co., a subsidiary of Monsanto Company. "Before coming to any conclusions, we need to look at other medical conditions that could have contributed to these events."
Patient information materials provided by Searle & Co. also state stomach ulcers can occur in patients using CELEBREX® without the problem being evident. So patients and their doctors should watch for signs and symptoms of stomach bleeding.
Source: http://www.arthritis-glucosamine.net/arthritis/CELEBREX®-side-effects-Vioxx®-side-effects.html
CONTACT AN EXPERIENCED CELEBREX LAWYER
Several thousand people have contacted us to help them find an experienced Celebrex lawyer. Every month, more than 100,000 people visit our legal help centers seeking help for their family's legal needs. In the past 5 years we have we helped thousands of people get their cases settled with experienced legal representation in each state.
There is NO COST or obligation for this service. |
