Monthly Archives: October 2007

Sprint Fidelis Recall Spurs More Questions Than Answers

When the popular Medtronic Sprint Fidelis defibrillator was voluntarily withdrawn from the market, some industry officials praised the medical device maker for proactively removing a potentially dangerous product from the market. Two weeks later, Medtronic’s decision is coming under scrutiny. The Sprint Fidelis problem surfaced in January 2007 after pacemaker patients began complaining of multiple electrical shocks. Their cardiologists checked hospital records and notified Medtronic of the problem. On March 21, 2007 Medtronic sent a “Dear Doctor” letter stating that the company had received reports of fracture rates in the Sprint Fidelis 6949 and that a limited number of doctors had experienced fracture problems. The Medtronic letter intimated that the fractures were a result of improper procedure on the part of the doctors. However, some cardiologists disagreed with Medtronic’s insinuation. Notably, Dr. Robert G. Hauser, who had been instrumental in triggering the Guidant pacemaker recall, and Linda Kallinen, Minneapolis Heart Institute’s director, combed the data and found similar fractures in the leads of the Sprint Fidelis defibrillator.
It’s disturbing to note that Medtronic had known that the fractured lead wires had been linked to 5 deaths since August 2006 but failed to act until the situation became a crisis in October 2007.

Miscarriage, Birth Defects Added to Cellcept Problems

Cellcept, a drug used in heart, liver, and kidney transplant patients, has been linked to miscarriages and birth defects in female users of child-bearing age, according to the FDA. Cellcept, an immunosuppressant drug, already carries a black box warning is designed to keep the immune system from attacking the new organ. Roche, the manufacturer of Cellcept, has sent a letter to health officials, urging women to obtain a negative pregnancy test prior to beginning a regimen of Cellcept.

Another Food Recall

Another food item has been recalled due to improper labeling of the product’s ingredients. This time the culprit is Bell’s Fishery of Michigan. Their Whitefish pate has been recalled because the product’s label failed to disclose that the pate contains milk, soy, and egg products. For someone who has an allergy to one or all of these ingredients a mistake like this can be deadly. This type of food problem is as dangerous and worrisome as the food contamination recalls we seen with contaminated spinach, lettuce, and peanut butter.

FDA Criticizes Ketek Manufacturer Aventis

The FDA has publicly criticized Aventis, the manufacturer of the antibiotic Ketek for not taking action about safety reports it had concerning the risk of serious liver damage. The critical letter was posted on the FDA website. Ketek was approved for use in 2004. The doctor who signed up the most patients for clinical trials plead guilty to fraud. Ketek’s problems come in the midst of an increasing awareness of how drug companies sometimes hide unfavorable data from consumers and health officials in order to increase profits.

FDA Pushes For Avandia Black Box Warning

Citing the risk for heart attacks, the FDA is pushing Glaxo Smith Kline, the maker of Avandia, to put the strongest possible warning on its Avandia labels. Avandia already carries a black box warning for heart failure. The new warning would be more serious in that it would warn doctors and consumers about the potential risk for heart attacks. An FDA analysis of multiple studies found that Avandia poses a 38% increase in the risk of ischemic incidents. An ischemic event occurs when blood flow is cut off from the heart resulting in subsequent heart attacks.

Food Inspections Falling Short

Five years ago, the federal government decided to increase safety measures concerning the manufacture and processing of foods. Yet, the procedures are not working as had hoped. In the last month, Topps Meat Co. went out of business after its ground beef patties were found to be contaminated with the deadly e coli bacteria. Previous food contamination cases involved spinach, lettuce, and ice cream. This has led some industry analysts to conclude that the new safety measures enacted five years ago are not being enforced in all food processing plants. This poses a serious threat to consumers and their health as well as consumer confidence in the grocery market.

Medtronic Will Face a Class Action Lawsuit

As a result of broken leads in its Sprint Fidelis defibrillator, Medtronic is facing two class action lawsuits-one has been filed in Puerto Rico and another in Canada. The Sprint Fidelis broken lead wires have been linked to 5 deaths as a result of excessive or improper shock delivered to the heart. The defibrillator is supposed to jolt the heart if its rhythm becomes uneven, too rapid, or too slow. The Sprint Fidelis sometimes works when it is not needed and on other occasions it doesn’t send the electrical jolt to the heart.

Viagra, Levitra, Cialis Linked to Hearing Loss

Two years ago, impotence drugs such as Levitra, Viagra, and Cialis were linked to vision loss in some patients. Now, the PDE-5 inhibitors or erectile dysfunction drugs have been associated with hearing loss in some patients. The studies which showed the link between hearing loss and the administration of Levitra, Viagra, and Cialis prompted the FDA to add a warning to the label of these drugs.

Sprint Fidelis Defibrillator May Pose More Risk to Young

Medtronic’s Sprint Fidelis defibrillator, which has drawn scrutiny because of the potential for lead fractures. The leads connect the defibrillator to the heart and are causing the defibrillator to deliver unnecessary and massive shocks, emit a beeping sound, or to not operate at all. The young may be more affected by this defect since they tend to lead a more active life and such activities may increase the risk of lead fracture. On October 15, 2007, the FDA urged Sprint Fidelis defibrillator patients to contact their physician immediately if they experience multiple shocks, lightheadedness, fainting, or palpitations.

Eli Lilly Diabetes Drug May Cause Fatal Pancreatitis

Byetta, Eli Lilly’s diabetes drug may be linked to a fatal form of pancreatitis, according to the FDA. The government agency is warning doctors and health professionals of the possible link. Byetta has been used by 70,000 patients since coming on the market. If you’re taking Byetta or have taken Byetta, you need to be aware of the symptoms of pancreatitis which include severe abdominal pain, nausea, vomiting, diarrhea, upper abdominal pain, and indigestion. The pain associated with pancreatitis is persistent and acute.