Unfortunately, there are many drugs on the market which are inherently dangerous. Many have not received FDA approval but are being sold in health food stores and by organic retailers; many more FDA-approved drugs were not adequately tested for side effects before being made available to the public. Even if a drug has since been taken off the shelves, parties who have been injured by those drugs are still entitled to compensation under product liability law.

Vioxx

Millions of arthritis victims hailed the 1999 release of Vioxx, a non-steroidal anti-inflammatory medication, as a miracle. The drug proved highly effective for managing acute forms of pain, and in 2000, a clinical trial was begun to study its ability to prevent recurring colon polyps. While Vioxx was found to successfully prevent the formation of new polyps, after 18 months, a significant number of the patients in the study developed cardiovascular problems. Twice as many Vioxx recipients suffered strokes, heart attacks or blood clots as those patients who received placebos.

While Merck & Co., manufacturer of Vioxx, claims the risks posed by long term use of Vioxx are relatively low, on September 30, 2004 the company chose to voluntarily halt the clinical trial and remove the drug from pharmacies worldwide. With as many as 80 million users worldwide, the Vioxx recall is considered one of the largest in history.

Merck’s decision to remove Vioxx from pharmacies is a relief, but for people who have used the medication since it was released five years ago, this action came too late.

Zometa®, Aredia®, and Fosamax®

Attorneys of Childers, Buck, & Schlueter, LLP, in Atlanta, Georgia are currently accepting and investigating cases throughout the United States involving takers of the drugs Fosamax® (alendronate), Zometa® (zoledronic acid), and Aredia® (pamidronate). These drugs are members of the family of drugs known as bisphosphonates. A link has been found between bisphosphonates and a bone disease called osteonecrosis of the jaw (ONJ). This important discovery shows a high probability that Fosamax®, Zometa®, and Aredia® side effects include osteonecrosis of the jaw.

If you or a loved one has suffered from complications due to oral surgery while taking Fosamax, Aredia or Zometa, you could be eligible for compensation. The attorney’s at Childers, Buck, & Schlueter, LLP, have extensive knowledge of Food and Drug Administration regulations, as well as product liability law. They are experienced pharmaceutical lawyers. Contact Childers, Buck, & Schlueter, LLP, for more information today.

More Information about Bisphosphonates

Bisphosphonates are drugs that alter calcium levels in bone structure. Fosamax, Aredia and Zometa are potent intravenous bisphosphonates developed by Novartis Pharmaceuticals Corporation to be used in the management of metastatic disease to the bone and in the treatment of osteoporosis. Aredia is used for the treatment of osteolytic metastases of breast cancer and osteolytic lesions of multiple myeloma, as well as hypercalcemia of malignancy (HCM) and Paget’s Disease. Zometa is used for the treatment of HCM, and for the treatment of patients with multiple myeloma and with metastases from solid tumors. Bisphosphonate therapy is designed to strengthen bone and to help prevent the fractures and pain that often result from bone metastases.

The problem with Zometa and Aredia, which one clinical professor characterized as “a possible epidemic,” is that while these drugs may help prevent fractures in the hip and spine, they may also disrupt bone remodeling process (osteoclast/osteoblast axis) in the jaws. This may lead to bone death in the jaw.

Between 2001 and 2003, the Chief of Oral and Maxillofacial Surgery at a Long Island hospital noticed an alarming trend of osteonecrosis (bone death) of the jaw in patients who were undergoing oral surgery. The only commonality with these patients was that they were all taking bisphosphonates. While most of the bone death sufferers were taking large, intravenous doses of Aredia or Zometa, six of the patients had taken the smaller, oral dose of Fosamax.

The discovery, published in the Journal of Oral and Maxillofacial Surgeons in May of 2004, prompted both the Food and Drug Administration (FDA) and Novartis, the manufacturer of Aredia and Zometa, to issue a warning to health care professionals on September 24, 2004. The warning letter contained information about the risks of osteonecrosis of the jaw.

Aredia had been on the market since 1999, and the final pre-market submission of the product label to the FDA regarding the drug’s potential hazards and precautions mentioned nothing about potential osteonecrosis. Similarly, the pre-market label for Zometa, on the market since 2001, made no such mention of dangers to patients of oral surgery. Nearly five years elapsed before hospitals, doctors and their patients were made aware of the specific hazards of these drugs.

Other Uses of Bisphosphonates

Smaller doses of bisphosphonates have been used to treat sufferers of osteoporosis. This is a condition that weakens the micro architecture of bones, increasing the chances of fractures in patients who have the disease. Osteoporosis occurs mostly in post-menopausal women. Fosamax is an oral bisphosphonate developed by Merck that is used to both reduce bone thinning and promote bone growth.

While Merck has recently complied with FDA requirements to update the labeling of Fosamax with the proper information in late 2005, there was a dangerous time lag between market availability and proper warning information. Merck has also said very little on the subject on their product website, listing indigestion and irritation of the esophagus as potential health risks, but not osteonecrosis of the jaw. There is also a page encouraging the continued use of Fosamax.

Sources of Information

USA Today, March 13, 2005. "Drug Linked to Death of Jawbone" by Rita Rubin

Aredia Prescribing Information, 1998. Food and Drug Administration

Zometa Prescribing Information, 2001. Food and Drug Administration

Fosomax Revised Prescribing Information, 2005. Food and Drug Administration.

"The Benefits of Fosomax," Merck and Co. Inc.

"Why Continue Taking Fosomax?" Merck and Co. Inc.

Tylenol and Liver Failure

Because it is available without a prescription and commonly used to treat a number of ailments, most people are unaware that Tylenol can be hazardous to their health. But Tylenol’s active ingredient, acetaminophen, has been linked to a number of serious side effects, namely liver damage caused by acetaminophen toxicity. In fact, according to some researchers, acetaminophen toxicity (essentially the poisoning of the liver) is accountable for up to 40 percent of all liver failures in the United States and sends approximately 56,000 people to the emergency room each year.

When taken as directed, acetaminophen is considered very safe. However, when heavy or even moderate drinkers or people who are fasting (such as someone who is not eating because she is sick with the flu) use the drug, serious problems can arise.

>> back to top

Accutane

Accutane is the most potent acne drug on the market today. Available only by prescription and typically as a last resort when all other treatment methods have failed, Accutane is highly effective at treating severe acne. Unfortunately, its strong formulation also means that a large percentage of patients experience side effects. Some of these side effects, such as very dry skin, sun sensitivity, and nausea, are relatively manageable.

But others are much more serious, however. For one, Accutane can cause a myriad of birth defects, including mental retardation and physical deformities. In addition, it can cause fetal death. Because of the extremely high risk of birth defects for women who are pregnant or become pregnant while on the drug, Accutane patients must agree with their doctors on a pre-prescription pregnancy prevention plan.

Accutane has also been linked to cases of depression, psychosis, and suicide, as well as ulcerative colitis, Crohn’s disease, inflammatory bowel disorder, rectal bleeding, abdominal pain, central nervous system injuries, pancreatitis, immune system disorders, lupus, hearing and vision problems, and thyroid disorders. The possible psychological effects of the drug prompted the FDA to revise warning labels in 1998 and to add a separate consent form acknowledging the risk.

To date, Accutane is believed to have played a primary role in at least 66 suicides and more than 1,373 cases of mental illness, according to a report in USA Today.

>> back to top

PPA (Phenylpropanolamine)

Commonly used as an ingredient in over-the-counter (OTC) appetite suppressants and some cold/cough medications, Phenylpropanolamine, or PPA, has recently been linked to some dangerous health problems, primarily hemorrhagic stroke. Hemorrhagic stroke, which causes bleeding in the brain, can lead to dementia, paralysis, coma, and death. In response to this serious charge, the Food and Drug Administration (FDA) asked in May 2000 that manufacturers voluntarily stop producing PPA and that and consumers cease using any medication that contains it.

Researchers believe that the risk of such side effects are slightly higher in women but that men, too, are susceptible to similar problems.

>> back to top

Childers Buck
& Schlueter
260 Peachtree St.
Suite 1601
Atlanta, GA 30303
Ph: (404) 419-9500
Fx: (404) 419-9501
>> Get Map