Archive for the 'Recall' Category

VIBE manufacturers told to recall machine

Thursday, November 6th, 2008

The people who manufacture a machine touted as a way to increase “inner-connectively to your DNA,” has been ordered to recall the device because it doesn’t do anything it claims to.

The Food & Drug Administration (FDA) has issued a Class I recall for the Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator sold by VIBE Technologies of Colorado.

The FDA says that that the VIBE Machine is not approved, and that the company’s claims that it can be used to treat or cure medical conditions and diseases such as cancer, depression, infection, and pain are unproven.

The company had further claimed that the machine “is a technological breakthrough that enhances the human body by helping it reach its optimum vibrational energy level.”

According to the FDA, it does no such thing.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Families sue hospital, drug maker over baby deaths

Monday, September 15th, 2008

According to an Associated Press story, the families of two newborns who died after they were inadvertently given massive doses of heparin have sued an Indianapolis hospital and the Illinois-based company that makes the blood thinner.

The suit filed recently in Marion Superior Court against Methodist Hospital and Deerfield, Ill.-based Baxter Healthcare Corp. doesn’t specify damages.

The suit was filed by an defective drug attorney for the parents of two of the three newborns who died in September 2006 following injections of heparin 1,000 times greater than the recommended dose for infants. Also suing are the parents of two infants who were overdosed but survived.

The error occurred in part because of a mix up over labeling.

A Baxter spokeswoman said the deaths were tragic but preventable, and it is vital that clinicians always read the name and dose of a drug before giving it to a patient. Baxter changed the labeling on its heparin vials in October 2007.

A spokesman for Clarian Health Partners, of which Methodist is part, said the company did not have all the details of the litigation and had no comment.

Actor Dennis Quaid and his wife sued Baxter last year after their newborn twins got massive doses of the blood thinner at a hospital.

These families aren’t the only ones battling drug companies over wrongful deaths due to defective drugs or defective labeling. It is advisable to locate an experienced defective drug attorney in case legal advice is necessary for a heparin lawsuit or settlement .

FDA strengthens arthritis drug warnings

Monday, September 8th, 2008

The US Food and Drug Administration (FDA) has ruled to include stronger warnings for fungal infections caused by arthritis drugs.

The warnings apply to drugs like Amgen, Inc.’s Enbrel, Johnson & Johnson’s Remicade, Abbott Laboratories’ Humira, and UCB SA’s Cimza. The drugs Enbrel, Remicade, and Humira were among the top 25 selling drugs last year, with $13.5 billion in combined sales.

They are usually used to treat rheumatoid arthritis. According to the FDA, at least 241 patients have developed histoplasmosis—an infection caused by a fungus found in the Ohio and Mississippi river valleys. Twelve of the 45 reported deaths were caused by doctors who didn’t recognize the infection and delayed treatment for the infection; even more deaths have been reported from other fungal infections.

The FDA has forced companies to strengthen their existing cautions in the strictest form of caution: a black box in the drugs’ prescribing information. The drug manufacturers must also educate doctors about the risks and symptoms of fungal infections.