Pain Relief—The Current Controversy and Alternatives

But most of these painkillers or Pain Relief medicines have adverse side effects, and because of that it has become a controversial issue. We are discussing one of the most popular drugs called Vioxx.

US pharmaceutical giant Merck announced a global withdrawal of its blockbuster arthritis drug Vioxx (Rofecoxib) after a study showed it increased the risk for strokes and heart attacks. Law firms have already filed cases, or are otherwise investigating individual lawsuits against Merck, the maker of Vioxx. There are many published reports from many reliable sources including FDA (and even Merck itself), showing clearly the possible side effects of this much hyped and most criticized drug called Vioxx.

The US Food and Drug Administration advised patients using the drug to see a doctor to find an alternative treatment to Vioxx, which is scientifically known as rofecoxib, and added that it would study the effects of other drugs in the same class.

The FDA announcement is not surprising. In Merck's Vioxx Gastrointestinal Outcomes Research report published in the New England Journal of Medicine (November 23, 2000), Merck compared the effectiveness of Vioxx (rofecoxib) to naproxen. The study shows a statistically significant increase in heart attacks in the rofecoxib group (0.5 percent) compared to the naproxen group (0.1 percent). There were 20 heart attacks suffered by 4,047 Vioxx patients and 4 heart attacks in 4,029 naproxen patients. While the absolute numbers are low, this is a five-fold increase that statistically is highly significant and merited further studies. In addition the study reported increased problems with blood clotting that results in strokes and leg clots.

The drug has been on the market around the world since about 1999 and has been prescribed millions of times. In 2003 alone, the drug accounted for $2.5 billion in sales.

According to Merck's own FDA-approved label, Vioxx has a number of potential side effects. These are listed below:

• Body as a Whole: abdominal distension, abdominal tenderness, abscess, chest pain, chills, contusion, cyst, diaphragmatic hernia, fever, fluid retention, flushing, fungal infection, infection, laceration, pain, pelvic pain, peripheral edema, postoperative pain, syncope, trauma, upper extremity edema, viral syndrome.

• Cardiovascular System: angina pectoris, atrial fibrillation, bradycardia, hematoma, irregular heartbeat, palpitation, premature ventricular contraction, tachycardia, venous insufficiency.

• Digestive System: acid reflux, aphthous stomatitis, constipation, dental caries, dental pain, digestive gas symptoms, dry mouth, duodenal disorder, dysgeusia, esophagitis, flatulence, gastric disorder, gastritis, gastroenteritis, hematochezia, hemorrhoids, infectious gastroenteritis, oral infection, oral lesion, oral ulcer, vomiting.

• Eyes, Ears, Nose, and Throat: allergic rhinitis, blurred vision, cerumen impaction, conjunctivitis, dry throat, epistaxis, laryngitis, nasal congestion, nasal secretion, ophthalmic injection, otic pain, otitis, otitis media, pharyngitis, tinnitus, tonsillitis.

• Immune System: allergy, hypersensitivity, insect bite reaction.

• Metabolism and Nutrition: appetite change, hypercholesterolemia, and weight gain.

• Musculoskeletal System: ankle sprain, arm pain, arthralgia, back strain, bursitis, cartilage trauma, joint swelling, muscular cramp, muscular disorder, muscular weakness, musculoskeletal pain, musculoskeletal stiffness, myalgia, osteoarthritis, tendinitis, traumatic arthropathy, wrist fracture.

• Nervous System: hypesthesia, insomnia, median nerve neuropathy, migraine, muscular spasm, paresthesia, sciatica, somnolence, vertigo.

• Psychiatric: anxiety, depression, mental acuity decreased.

• Respiratory System: asthma, cough, dyspnea, pneumonia, pulmonary congestion, respiratory infection.

• Skin and Skin Appendages: abrasion, alopecia, atopic dermatitis, basal cell carcinoma, blister, cellulitis, contact dermatitis, herpes simplex, herpes zoster, nail unit disorder, perspiration, pruritus, rash, skin erythema, urticaria, xerosis.

• Urogenital System: breast mass, cystitis, dysuria, menopausal symptoms, menstrual disorder, nocturia, urinary retention, vaginitis.

If you have taken Vioxx in the past, and you have suffered a heart attack or stroke (or other serious complication), you have certain legal rights, and you may have a legal case against Merck, the maker of Vioxx. You should thus contact a Vioxx lawyer as soon as possible.

Let’s see some more information about the alternatives to Vioxx:

Indeed Vioxx is not the only Pain Relief drug available for patients experiencing arthritis pain, so the potential risk is not worth taking. There are plenty of other alternatives. Vioxx belongs to a small class of drugs called Cox-2 inhibitors. One alternative is to switch patients to one of the two other drugs in this class i.e. Celebrex and Bextra. Another alternative is to switch to one of the drugs in the large group called nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen or ibuprofen.

It's not yet clear whether Celebrex and Bextra have the same heart effects as Vioxx. There's some evidence that Celebrex is more heart friendly than Vioxx, but this is far from proven, says Carl Lavie, MD, medical co-director of cardiac rehabilitation and preventive cardiology at the Ochsner Clinic Foundation in New Orleans.

Lavie also added, "Celebrex doesn't raise blood pressure at high doses -- certainly not at the doses we use -- and there seems to be no increase in heart disease events. I would feel very comfortable, if a patient needs a Cox-2 inhibitor, to use Celebrex. This might be the case with Bextra, too, but I am not aware of the same kind of positive findings."

Some other alternatives are:

Bromelain: An anti-inflammatory and digestive aid, Bromelain has been used traditionally in Japan, Hawaii, and Taiwan, which stimulated interest by researchers in Europe. Now, Bromelain is one of the top single herbal products sold in Germany.

MSM (Methyl Sulfonyl Methane): MSM is a compound normally found in foods. It is believed to relieve the pain of osteoarthritis and help strengthen collagen in the joints.

Glucosamine: Glucosamine is primarily used to treat osteoarthritis. Research indicates that glucosamine is as effective as low doses of nonsteroidal anti-inflammatories such as ibuprofen. It appears to relieve pain and improve movement. It also slows the progression of the disease and protects joints from further damage. In some studies, x-rays have shown that glucosamine prevents progressive damage to the joints.

What do you need to do if you are taking Vioxx?

According to many experts and doctors, if you're taking Vioxx now, don't panic. The heart attack and stroke risk linked to Vioxx is very small. Before switching to another drug, it is very important to talk with your doctor. NSAIDs and other Cox-2 inhibitors can cause other serious side effects. So, if you're now taking Vioxx, it's important for you to schedule a talk with your doctor. Pharmacies won't be refilling current prescriptions. You don't need to worry about slowly stopping Vioxx. After talking to your doctor, it won't hurt to stop all at once and start taking something else if needed.

Merck is making a lot of information available to consumers. The company is planning to take out newspaper ads warning patients to see their doctors. And they're making more information available on the merck.com and vioxx.com web sites, and via a toll-free call to (888) 36VIOXX. The FDA also has information available on its web site and via a toll-free call to (888) INFO-FDA.

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