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.
Zicam Gets Rid of More than Colds!
June 19, 2009
Zicam, the cold remedy marketed by Matrixx Initiatives, is the subject of a warning letter from the Food and Drug Administration (FDA).
Several Zicam products have been associated with loss of sense of smell, or anosmia.
The warning advises that the product can no longer be marketed without FDA approval.
If you or a loved one has suffered lost sense of smell from Zicam use call your doctor immediately. Then, contact The S.E. Farris Law Firm for a Free consultation. You may reach us at 314-A-LAWYER or by clicking here.
Doctors Question Avandia Safety
June 10, 2009
Some doctors don’t agree that a recent safety study which claims Avandia (rosiglitazone) is safe, is as conclusive as presented at the American Diabetes Association meeting. Some physicians are calling the study “flawed.” Avandia is used used with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes (non-insulin-dependent diabetes).
In an editorial in the Lancet–where the research was published–two doctors wrote that the study’s limitations prevent any “definitive conclusions” about Avandia’s effects on cardiac safety. Avandia has been haunted by safety concerns for two years, ever since an analysis found that patients using the diabetes med were more likely to suffer a heart attack than people taking other diabetes remedies were.
A GlaxoSmithKline (the makers of Avandia) funded study, called the Record, found that Avandia does not boost overall cardiovascular risk, though it does increase the risk of heart failure. “Record provides important and reassuring information about Avandia for physicians fighting diabetes,” said Dr. Ellen Strahlman, GSK’s chief medical officer,said in a statement on the study’s release. “Clinical outcomes trials like this offer the highest standard of evidence when considering the benefits and risks of medicines.”
Some doctors beg to differ. They told the Wall Street Journal that the overall rate of cardiovascular problems among patients in the trial was abnormally low. A significant number of Avandia patients took statins–10 percent more than the non-Avandia users, Forbes reports—and those cholesterol-fighters are known to cut heart attack risk. Plus, a relatively high level of patients dropped out of the trial entirely, which could have compromised the results, they said. (Glaxo said about 45 percent of participants dropped out at some point, but that dropout rate didn’t affect the primary aim of the study.)
Meanwhile, another physician told the WSJ that the Record trial may have been too small to be sure Avandia is clear of increased heart attack risk. And Forbes is questioning the fact that Glaxo didn’t make clear that so many patients had dropped out of the Record study. Steve Nissen, the cardiologist who launched the Avandia controversy with his meta-analysis, went so far as to call the trial “worthless” because of the dropouts and the statin-drug use.
James Stein of the University of Wisconsin-Madison told Forbes that Record patients and doctors knew which drugs they were on, weakening the result. Plus, in a subset of Avandia patients who had established heart disease, the risk of heart attack increased by nearly 26 percent, he said.
So it appears the debate over Avandia is far from over.
If you or a loved one has suffered a heart attack which you believe may be related to Avandia use, contact The S.E. Farris Law Firm for a Free consultation. You may reach us at 314-A-LAWYER or by clicking here.