Philadelphia Personal Injury Lawyer - FDA

FDA Warning For Some Diabetic Testing Strips

Jamie Sheller — Mon, 17 Aug 2009 15:33:07 GMT

Recently, the FDA issued a warning regarding the use of certain types of glucose testing strips. According to the FDA, some of the strips can't distinguish between maltose, xylose, galactose, and other sugars. Such problems can produce falsely high readings, leading to dangerous overdoses of insulin. High doses of insulin can cause severe injury or death. Due to these dangers, the FDA warns that patients using therapies that include nonglucose sugars should not use GDH-PQQ glucose test strips. Dialysis patients or those with recent surgeries are more likely to use therapies that contain nonglucose sugars.

From 1997-2009, 13 deaths associated with false results in GDH-PQQ test strips were reported to the FDA. Those reports came from healthcare facilities, and prior to death, the patients suffered hypoglycemia, neurologic deterioration, severe hypoxia, and coma. The FDA safety alert included the following types of testing strips: ACCU-CHEK Comfort Curve test strips, ACCU-CHEK Aviva test strips, ACCU-CHEK Compact test strips, ACCU-CHEK Go test strips, ACCU-CHEK Active Freestyle test strips, Freestyle test strips, TRUEtest test strips, and Abbot Diabetes Care Freestyle test strips.

Originally posted at InjuryBoard by Jamie Sheller

Undeclared Steroids In Dietary Supplements

Jamie Sheller — Mon, 27 Jul 2009 11:12:41 GMT

According to federal authorities, two over-the-counter dietary supplements, Tren Xtreme and Mass Xtreme, contain illegal man-made steroids. The products are made by American Cellular Labs, and are sold over the internet and in Mass Muscle supplement stores. Authorities say that Tren Xtreme and Mass Xtreme are marketed as a "potent legal alternative to" steroids, and are popular among high school footbal players. The man identified as the owner of American Cellular Labs, claimed that he sold the company last year, and no one from Mass Muscle stores was available for comment. The head of the United States Anti-Doping Agency says that these products are popular dietary supplements because they promote quick muscle mass and strength. Their use among young people is of concern because steroid use by preteen and teenage boys can lead to the halt of bone growth. The FDA and prosecutors from the Northern District of California branch of the United States Attorney's office are leading the investigation into American Cellular Labs. Dietary supplements are under the jurisdiction of the FDA, but the FDA can only institute action if a current product on sale is identified as harmful or adulterated. However, a supplement is considered as an illegal, unapproved drug, if it contains an undeclared active pharmaceutical ingredient. Using supplements with undeclared illegal pharmaceutical ingredients is risky because such drugs have risks. The risks cannot be monitored for, if the consumer is unaware of the ingredient.

Originally posted at InjuryBoard by Jamie Sheller

Homeopathic or "Natural" Remedies Carry Risks

Jamie Sheller — Mon, 29 Jun 2009 14:21:56 GMT

Several recent recalls illustrate the dangers that can be posed by homeopathic or "natural" health remedies, which generally aren't required to go through the same kind of FDA-approval process as prescription drugs. Often, people mistakenly believe that products labeled homeopathic or "natural" are automatically safe.

In May 2009, Hydroxycut dietary products were recalled from the market after the products were linked to liver damage. Hydroxycut products are used for weight loss, as energy enhancers and fat burners. Iovate Health Sciences Inc. marketed Hydroxycut, and the products were widely distributed in grocery stores, health food stores and pharmacies. At the time of the recall, the FDA recommended that people immediately stop using Hydroxycut products.

In June 2009, consumers and doctors were notified by the FDA and Hi Tech Pharmaceuticals that Stamina Rx products were recalled. Stamina Rx was sold nationwide in health food stores and drug stores, and was marketed as a natural male enhancement product. The FDA determined that Stamina Rx contained an undeclared ingredient - the drug benzamidenafil, which is in the same class of drugs as some that are FDA-approved to treat erectile dysfunction. Benzamidenafil is not FDA-approved, and may interact dangerously with some other drugs and cause a dangerous drop in blood pressure. Consumers are urged to stop using Stamina Rx products immediately.

Another recent homeopathic remedy recall involved Zicam. Some Zicam nasal cold remedies were recalled by Matrixx Initiatives in June 2009, after the FDA warned that the products were unsafe. The FDA issued its warning about Zicam after hundres of reports that people lost their sense of smell after using Zicam. According to the FDA, Zicam products were also unlawfully marketed. Over the past several years, Matrixx, the maker of Zicam, has settled hundres of lawsuits regarding Zicam. Matrixx is also being investigated by the Securities and Exchange Commission.

For over 25 years, Sheller P.C. has aggressively represented individuals and classes of individuals who have been injured by defective products, including pharmaceuticals and medical devices. We also represent those who have suffered injuries due to other causes, such as inadequate medical treatment , improper business practices, or accidents.

Originally posted at InjuryBoard by Jamie Sheller

Recall of Intra-aortic Balloons

Jamie Sheller — Thu, 23 Apr 2009 16:21:48 GMT

Recently, the FDA issued a Class 1 recall of some intra-aortic balloons, manufactured by Arrow International. The recalled models include various 30 cc, 40 cc and 50 cc intra-aortic balloons manufactured from January 2008 through January 2009. Such pumps are a component of the Intra-Aortic Pump System which helps increase blood flow to the hearts of critically ill people. The recalled pumps have a faulty connector in their tubing assembly that may result in an incorrect volume setting. Users should return the the recalled products. Class 1 is the most serious type of FDA recall, which is used when there is a reasonable probability that a product will cause serious injury or death. Arrow International is based in Massachusetts.

Originally posted at InjuryBoard by Jamie Sheller