Another Digoxin Recall
July 29, 2009
As Medication Solutions, LLC announced that Digoxin, prescribed for patients suffering from heart failure or abnormal heart rhythms, showed up in different sizes which had a bearing on the dose. The variations in the sizes of the medications could create problems in either too little a dose or too much. Digoxin is a generic version of Digitek, and is marketed by Caraco Pharmaceutical Laboratories.
The Digoxin packaged by AS Medication Solutions includes all tablets that are USP 0.25 mg and were distributed before March 31, 2009 with an expiration date up to and including August, 2011. The drug is sold in scored white tablets, imprinted with the number 441 and an NDC number 54569-5758-0.
Patients taking Digoxin of a higher than proper dose can suffer from digoxic toxicity- especially in patients with kidney problems. Side effects of digoxin toxicity include low blood pressure,cardiac instability, bradycardia, and vomiting. Digoxin toxicity is very serious and can result in death.
On the other hand, a low dosage will not deliver the appropriate medication level and therefore the patient will not receive the benefit of the drug.
If you have taken or are still taking Digoxin as a treatment for heart problems, check your packaging. Because the product does not expire until 8/2011, you could very well have recalled medications in your possession. The FDA warns against taking this product- either return it to the company for reimbursement or speak with your physician about an alternative form of medication.
If you or a loved one has had problems from Digoxin or Digitek, contact The S.E. Farris Law Firm for a Free consultation. You may reach us at 314-A-LAWYER or by clicking here.
Denture Cream Poisoning from Zinc
July 23, 2009
Approximately 35 million people use denture adhesives called denture creams, typically when they wake up and after they eat. Ingestion of denture cream is a known cause of zinc-induced copper deficiency resulting in neurological problems. Zinc is very common and an important dietary requirement. Humans typically ingest between eight and eleven milligrams per day (often through red meat, nuts and grains).
However, lawsuits alleging zinc toxicity of denture creams are showcasing how too much of a good thing can be harmful. Some consumers who used denture cream were exposed to at least 330 milligrams of zinc daily, far more than the recommended daily intake of 40 milligrams.
Denture creams were approved more than 30 years ago as a “Class 1 medical device” according to a statement by the FDA. Class 1 medical devices are considered low-risk and are not required to list the ingredients on the label.
Zinc in denture cream is absorbed through the gums. High levels of zinc inhibit copper absorption, which can cause a copper deficiency and anemia. It can also reduce the function of the immune system. One of the most disabling side effects of zinc poisoning are called “neuropathies.” There are more than 100 different kinds of neuropathy, although peripheral neuropathy is the most common form. According to The Neuropathy Association, peripheral neuropathy is “the result of damage caused to the nerves, which disrupts the body’s ability to communicate with its muscles, skin, joints, or internal organs.” Symptoms include numbness or tingling in the extremities, abnormal sensations, foot pain, loss of balance, and inability to hold objects.
Though reducing zinc intake to normal levels can help, oftentimes the damage is not reversible, and there is no cure. Victims injured by denture cream may have extensive medical and other needs, which they cannot afford on their own.
There are several lawsuits filed against GlaxoSmithKline and Proctor and Gamble for their denture cream products—Poligrip and Fixodent. The lawsuits allege that the denture cream manufacturers failed to warn consumers about the risks of zinc toxicity.
FDA Statement
“The U.S. Food and Drug Administration (FDA) regulates denture adhesives, which are medical devices under the Food, Drug and Cosmetic Act. A denture adhesive is a device intended to be applied to the base of a denture before the denture is inserted in a patient’s mouth to improve denture retention and comfort. FDA has classified this product as a low-risk device (class I). While manufacturers are not required to submit marketing applications to FDA for most class I devices, they still must register and list a class I device with the agency and comply with other applicable FDA requirements. These requirements include adverse event reporting, manufacturing controls, and labeling that is neither false nor misleading. FDA monitors adverse events from medical devices through mandatory and voluntary reporting systems. Manufacturers and hospitals are required by law to report deaths and serious injuries. Manufacturers also must report malfunctions that could result in death or serious injury. FDA reviews reports submitted to the agency and has authority to take immediate action, when warranted, to protect public health. Consumers can report problems experienced with any product to FDA either by phone (800-FDA-1088), fax (800-FDA-0178), on-line (www.fda.gov) or mail (MedWatch, The FDA Safety Information and Adverse Event Reporting Program, FDA, 5600 Fishers Lane, Rockville, MD 20852).”
If you or a loved one has suffered symptoms which you believe may be related to denture cream use, contact The S.E. Farris Law Firm for a Free consultation. You may reach us at 314-A-LAWYER or by clicking here.