Roven-Kaplan: Potentially Dangerous Drugs

Potentially Dangerous Drugs

Our attorneys are currently investigating or litigating cases concerning several potentially dangerous drugs. Although most remain on the market for patient use, many have been subject to FDA required label changes, voluntary manufacturer recalls, or are otherwise being studied for their hazardous effects. To learn more about the drugs that we are currently investigating, please click on the attached list for information on drug history, usage and potential dangerous side effects. To learn more about our work in this field, please contact John Roven or Hector Sandoval at 1-800-997-1505 or send us an e-mail with your questions (info@rovenlaw.com).

Nuvaring®

NuvaRing is a vaginal ring used as a contraceptive. The ring supplies a stream of hormones that prevent pregnancy. NuvaRing has been linked to various side effects including blood clots, toxic shock syndrome and possible pulmonary embolism.

Yaz® and Yasmin®

The blockbuster birth control pill with benefits, Yaz® was pitched as the choice for women desperate for relief from severe PMS and acne. But now, new independent studies have found that Yaz® carries higher blood clotting risks that other leading birth control pills. A lower-dose version of the same drug, called Yasmin®, was approved by the FDA in 2001.

Both Yaz® and Yasmin® have been linked to serious, life threatening side effects including:

Kidney Failure
Heart Attack
Stroke
Blood Clotting and
Deep Vein Thrombosis (DVT)

Mirena®; Intrauterine contraceptive (IUD)

Mirena® is a device manufactured by Bayer HealthCare Pharmaceuticals that, once put into place by a health care provider, is intended to provide contraceptive protection for up to five years. The plastic T-shaped device releases the synthetic progestogen levonorgestrel directly into the uterus. Like other contraceptives, Mirena’s hormone is designed to prevent pregnancy by thinning the lining of the uterus, preventing sperm from reaching and fertilizing an egg, and thickening cervical mucus to prevent sperm from entering the uterus.

Perforation of the uterus may occur when Mirena® is inserted, or the device may migrate from its original location and perforate or embed in the uterus after insertion. In both cases, Mirena® must be located and removed, often requiring surgery. Mirena® may also migrate outside the uterine cavity, causing adhesions or scarring (leading to infertility), peritonitis, pelvic inflammatory disease, intestinal perforations or obstruction, abscesses, and/or erosion of adjacent viscera like the vagina. Depending on the damage created, women may require total hysterectomy. Serious conditions may cause death.

Fosamax

Fosamax is a drug that was advertised, marketed and sold primarily for the treatment of Paget=s Disease and Osteoporosis. In addition, Fosamax was and is prescribed for off label uses including malignant conditions such as bone cancer.

Side effects: Potential side effects associated with the use of Fosamax have been reported to include Osteomyelitis. This is a painful condition which involves inflamation of the bone marrow. Fosamax has also been reported as associated with Osteonecrosis of the jaw. This a condition that is also known as aseptic necrosis of the mandible/maxilla. It is a terribly painful and dangerous condition resulting from infection and inflamation of bones insides the mouth and jaw area. Symptoms may take months to develop, and often become evident following some form of trauma to the tooth or jaw bone such as an extraction or other oral surgery that exposes the bone. Left untreated, the condition often causes the jaw bone to deteriorate and decay beyond repair.

In addition, a recent study in the New England Journal of Medicine (March 20, 2010) noted that women who have used Fosamax for a long time have suffered a high rate of fractures of the femur. Virtually all of these fractures occurred as a result of a minor fall from a normal standing position.

The FDA issued an alert in January 2010 concerning the possibility of severe bone pain related to Fosamax use. Fosamax was originally approved by the FDA in 1995. However, throughout the last 10 years, medical articles and case histories have reported frequent occurrence of these side effects.

Many state Dental Associations are now warning dentists to avoid invasive procedures (such as filling a cavity) in any patient actively taking Fosamax. Fosamax is a bisphosphonate drug. In 2008 the FDA issued a further alert regarding the possibility of severe bone joint or muscle pain in patients taking bisphosphonates.

Reglan (metoclopramide)

This drug has been used to treat many common gastrointestinal problems including GERD, acid reflux, and was used by some Obstetricians to treat the symptoms of morning sickness in pregnant women. Reglan has now been linked to the development of a debilitating condition called Tardive Dyskinesia, which is marked by involuntary repetitive movements similar to Parkinsons disease. Tardive Dyskinesia is difficult to treat and is rarely reversible.

Common side effects and co-morbid conditions which have associated with Reglan may include any of following:

1.         Involuntary or repetitive movements of the arms and legs
2.         Impaired movement of the fingers
3.         Parkinsons like symptoms
4.         Cervical dystonia (sometimes called torticollis)
5.         Abnormal facial grimacing or tics
6.         Rapid eye movements or involuntary blinking

In February 2009, the FDA mandated that manufacturers of Reglan and other metoclopramide containing drugs must warn of the risks of high dose or long term use. The FDA at that time mandated the use of a Ablack box@ warning on these drugs= labels:

ARecently published analysis suggest that metoclopramide is the most common cause of drug induced movement disorders. Another analysis of studied data by the FDA showed that about 20 % of a patients in that study who used metoclopramide took it for longer than 3 months. The FDA has become aware of continued spontaneous reports of Tardive Dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than 3 months.@

Reglan/metoclopramide has not been recalled from the market, but the FDA now requires the manufactures to provide all Reglan users with a medication guide. Reglan is available in multiple forms including tablets, oral solution and injections. Over 2 million people in the United States have used Relgan or other metoclopramide containing drugs.

Medication associated with Stevens- Johnson Syndrome

Steven-Johnson Syndrome (SJS) is a rare but serious condition which is also known as Toxic Epidermal Necrolysis (TEN). It has occurred following the use of certain over the counter and prescription medications. The symptoms of SJS usually begin with vague flu like symptoms. These symptoms may be followed by a painful rash that blisters and spreads to the epidermis (top layer of skin) and causes it to peel away and/or die. If SJS is not treated at its onset it may lead to serious complications which can include blindness, hearing loss and, ultimately, death. Treatment involves surgical removal of the damaged tissue and is similar to the treatment utilized for burn victims. Recovery can be slow and very painful depending on how far the condition has progressed before treatment is initiated.

The drugs most commonly associated with SJS / TEN include:

Allopurinol, Bactrim<7, Daypro (non steroid anti-inflammatories),
Dilantin 7, Tegretol 7 (this includes mood stabilizers containing carbamazepine).

Accutane ®

Accutane was originally developed for use in chemotherapy, it is now used as a drug to treat severe cases of acne. The manufacturer, Hoffmann LaRoche, removed the drug from the market in 2009. Accutane had been linked to several gastrointestinal and immune system diseases including Crohn’s Disease, Ulcerative Colitis, and Inflammatory Bowel Disease.

Wellbutrin® and Zyban®

Wellbutrin and Zyban are identical drugs which were marketed by GlaxoSmithKline. Wellbutrin was typically prescribed for various forms of depression. “Zyban” is commonly prescribed for smoking cessation. Recent studies have indicated a high index of suspicion in cases involving women who took one of these drugs during early pregnancy and then experience a birth of a child born with heart defects.