Producer of Vioxx, Merck, May Have Known of Harmful Side Effects

Merck, the drug company that puts out Vioxx, an arthritic painkiller, is accused of knowing the dangerous side effects of using the drug. It was pulled off the shelves on September 30, 2004 and made nearly $2.5 billion a year. The company is likely to face nearly 10,000 lawsuits due to the claim that the drug demonstrates an increased risk of heart attack and stroke in pill-takers of more than 18 months.

This was discovered by a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) sponsored by Merck that indicated that “Vioxx users have an increased risk of suffering heart attacks, strokes, or other cardiovascular injuries.” Most lawsuits have already occurred in Merck’s home state of New Jersey and involve users who have taken the drug in a smaller time frame than that, thus giving Merck the winning edge.

Vioxx is a part of the non-steroidal anti-inflammatory family that includes Advil, Motrin, Nuprin and Naproxen (Aleve). It is a cox-2 inhibitor, which means that it isolates the cox-2 enzyme without affecting the cox-1 which helped to end gastric problems and gave relief to users. It is thought to damage fatty compounds in lipids and increase the amount of blood clots in users. The drug has also been known to induce ulcers, bleeding and perforation. It may also be responsible for increased infections to the renal system, the liver and possibly cause anemia. Overall, it is estimated that 3.7 percent of patients using Vioxx for 18 months experienced one of the serious cardiovascular risks involved.

Merck has admitted that Vioxx causes heart attacks after 18 months, said Merck’s adversary Mark Lanier, the Texas plaintiff lawyer who won the verdict in state court in Angleton, Texas in an e-mail to CNNMoney.com. The ethical thing would have been to warn [the public]. I expect [to see] a further lack of ethics as Merck denies that Vioxx is dangerous at all now. They will try to sell the jury on the idea that Vioxx is a vitamin. It was also reported that Merck may have known evidence to back this up as early as 1997 that cardiovascular risks were likely in users. However it wasn’t until 2000 that the extent of these risks become more known and the study informed the public that “myocardial infractions or heart attacks was approximately 500% higher in patients receiving Vioxx compared to those receiving Naproxen.” However, side effects are not unheard of. “Nearly every prescription drug, and most over-the counter drugs, have side effects,” says Steven Findlay, director of research for the National Institute for Health Care Management (NIHCM).

The U.S. Food and Drug Administration has issued a list of other possible side effectsthat may affected past Vioxx users. The list includes: Chest pain, fluid retention, fever, palpitations, irregular heartbeat, digestive problems, ear, nose and throat problems, immune system deficiencies, metabolic side effects, respiratory problems and skin problems. Other studies have been done and past users may also experience abdominal tenderness/discomfort, chest pains, abscesses, cysts, angina pectoris, atrial fibrillation, hematomas, vomiting, blurry vision, conjunctivitis, allergies, weight gain and loss, change in appetite, asthma, psychiatric problems (e.g. anxiety and depression), and musculoskeltal problems including joint inflammation, muscle weakness/stiffness and pain.

Another great concern is that of kidney failure. Due to the Cox-2 inhibitors within Vioxx, there is potential that these could cause significant damage to the user’s kidneys and might lead to kidney failure for some patients. This was discovered because of a recent case of a women who suffered from kidney failure and had been taking Vioxx. The researchers and analysts decided to take the claim as a test and found related causes for this issue. A new study tested the claim and it is decided that while Vioxx may be considered safer than other drugs, it still significantly lowered the kidney’s ability to get rid of waste.

According to a recent USA Today article, nearly five people who took Vioxx also developed a type of meningitis, citing this as yet another rare, yet serious side effect of this off the shelf drug, the U.S. Food and Drug Administration report. This is just one of the seven cases reported to the FDA since May 99. All of the patients were taking the drug when they developed the disease, only two of these cases lacked enough information to determine the causes, but the other five were valid Vioxx users. The FDA has requested that Merck add meningitis to its’ list of potential side effects.

Merck’s own FDA-approved label listed a number of potential side effects. According to a published PDF by Merck themselves.
The list is as follows:

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 ain, peripheral edema, postoperative pain, syncope, trauma, upper extremity edema, viral syndrome.

Cardiovascular System: angina pectoris, atrial fibrillation, bradycardia, hematoma, irregular heartbeat, alpitation, 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, 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, skinerythema, urticaria, xerosis.
Urogenital System: breast mass, cystitis, dysuria, menopausal symptoms, menstrual disorder, nocturia, urinary retention, vaginitis.

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