Throughout the United States millions of individuals rely on pharmaceutical drugs and medications for evaluations, conditions, and treatments. Although the Food and Drug Administration (FDA) evaluates new drugs before they are sold on the market to ensure that the drug is safe for the public, defective drugs or drugs that should not be ingested by certain individuals are still found on the market.
If you believe a defective drug or pharmaceutical has caused you injury or illness it is imperative that you seek medical attention in order to avoid long term damage. Taking legal action immediately can ensure that you remain within the statutes of limitations, and are able to pursue your claim. Defective drugs that are in question are inclusive of but not limited to:
Zicam On June 16, 2009, the FDA alerted consumers that certain Zicam products, which contain zinc, are associated with long-lasting or permanent loss of smell (anosmia). The FDA advises consumers to discontinue using or discarding the following Zicam products:
Zicam Cold Remedy Nasal Gel,
Zicam Cold Remedy Swabs, and
Zicam Cold Remedy Swabs, Kids Size.
Although the Zicam Cold Remedy Swabs, Kids Size, has been discontinued, the FDA is acutely concerned that parents still have the product in their homes and have their children use the product.
Matrixx Initiatives is the company that markets Zicam nasal cold products, used by consumers to reduce the severity of their colds. However, these products contain zinc, and since 1999 the FDA has received 130 consumer reports of anosmia from the use of Zicam intranasal products.
Gadolinium Gadolinium (or gadodiamide), a non-radioactive substance, is used in patients undergoing Magnetic Resonance Imaging (MRI) procedures. Physicians inject the substance into the patient's bloodstream because gadolinium gathers in abnormal tissue, creating a contrast between normal and abnormal tissue. This contrast allows doctors to detect abnormalities, such as tumors, in the patient's body. Although medical practitioners may conduct an MRI without using gadolinium, physicians obtain more comprehensive diagnostic information when gadolinium is used as compared to when another contrast agent is used.
In 2006, the FDA issued a Public Health Advisory finding a link between gadolinium-based agents and NSF. NSF is a serious condition that involves fibrosis of the skin, joints, eyes, and internal organs. Fibrosis occurs when there is an excess development of fibrous connective tissues in organs and tissues. Patients with NSF experience skin thickening that may prevent the individual from bending or extending the joints. Fibrosis starts in the lower body parts, such as the thighs and lower abdomen, and can spread to different parts of the body. In extremely serious cases of NSF, patients are unable to walk and in some extreme cases patients can die from NSF.
On May 23, 2007, the FDA requested that manufacturers of gadolinium-based contrast agents to include a boxed warning, telling consumers that patients who have significant kidney insufficiency and who receive gadolinium-based agents are at risk of developing a deadly disease called nephrogenic systemic fibrosis (NSF) (or Nephrogenic Fibrosing Dermopathy). The warning would also state that patients immediately prior to or after liver transplantation, or those with chronic liver disease, and who are experiencing kidney insufficiency are at risk of developing NSF.
The FDA recommends that patients with kidney malfunction not be tested with gadolinium-based contrast agents, unless the physician determines that the diagnostic information would be essential and not obtainable through alternative means.
Hormone Replacement Therapy Hormone Replacement Therapy (HRT) is a type of treatment for menopausal and perimenopausal women who are seeking to prevent or ease the symptoms associated with menopause, such as hot flashes, vaginal dryness, and mood swings. During HRT, physicians prescribe medication containing female hormones, such as estrogen and progestin. Physicians were also under the belief in the past that by increasing estrogen levels after menopause, heart disease and osteoporosis would be prevented.
However, the Women's Health Initiative (WHI) conducted a clinical trial on healthy postmenopausal women beginning in 1991 to determine the effects of postmenopausal hormone therapy. The trial consisted of two studies--the estrogen-plus-progestin study of women with a uterus, and the estrogen-only study of women without uteruses. The findings of these studies showed that women in the estrogen-alone cohort were more likely to have heart disease risk factors, such as high blood pressure and blood cholesterol. Further, compared with the placebo, the estrogen plus progestin group had an increased risk of heart attack and risk of stroke. For more information on WHI's clinical trial results, please see WHI's Question and Answer page.
To ensure that women are fully informed as to the risks and benefits of HRT, we have encouraged the manufacturers of HRT medications to modify their labels to include information on WHI's clinical trial.
Zyprexa Zyprexa (or olanzapine) is an antipsychotic medication that is used to treat schizophrenia and bipolar disorder in patients. The drug was manufactured by Eli Lilly and was the company's best-selling medication for schizophrenia. However, studies conducted in Europe and Japan, showed that Zyprexa caused significant increases in a person's blood-sugar levels. Several patients even died after suffering complications from Zyprexa-induced blood-sugar increases. A study conducted by Duke University in 2002 showed an increased risk of developing diabetes from using Zyprexa.
In addition to requesting Eli Lilly to have warning labels regarding the link between Zyprexa and diabetes on Zyprexa packaging material, the FDA has advised patients using Zyprexa and other antipsychotic medications to be monitored by their doctors for abnormal changes to their blood-sugar levels.
Seek Medical Treatment If you or someone you know has taken any of the drugs discussed above, and have suffered injuries as a result, seek medical treatment immediately. It is also important for you to seek legal assistance from an experienced attorney who is familiar with defective drug and pharmaceutical cases. Contact the National Justice Coalition today to be connected with a lawyer in your area who can evaluate and assist you with your defective drug case.