Taking Mirapex or Requip for Restless Leg Syndrome? Beware of “Disease Mongering”

“Disease mongering” is a term coined by some drug-marketing critics to describe what they view as an effort by pharmaceutical companies to enlarge the market for a drug by convincing people that they are suffering from something that can be medically treated and encouraging them to ask their doctor to prescribe the drug in order to enlarge the market for drug treatment and promote a particular product.

An example of such a tactic is advertising for Restless Leg Syndrome (RLS), a neurological disorder characterized by unpleasant feelings in the legs with an associated uncontrollable urge to move when resting because … Read the rest

Off-Label Marketing of Fentora Leads to $425 Million Penalty

On September 27, 2007, the Food and Drug Administration issued a warning about the risk of potentially fatal overdoses with Fentora, a narcotic painkiller manufactured by Cephalon. The action came less than two weeks after the company sent a letter to doctors notifying them of three drug-related deaths. Cephalon has just recently agreed to settle the U.S. Justice Department investigation of its allegedly illegal off-label marketing of Fentora (fentanyl buccal) and Actiq outside the indications on their labels. Cephalon denied it marketed the drugs improperly and claims the problems are a result of improper prescribing.

In settling, they have … Read the rest

Heart Surgery Drug Trasylol Withdrawn from Market

The German pharmaceutical company, Bayer AG, announced that it will withdraw Trasylol, its controversial drug used for heart surgery, from the market. The withdrawal was due in part to a study performed in Canada which suggested that Trasylol increased rates of death.

The New England Journal of Medicine published the results of a study it conducted finding that Trasylol increased the risks of stroke, heart attack, kidney failure, and death. The research concluded that stopping the use of Trasylol would result in the prevention of 10,000 to 11,000 cases of kidney failure per year along with the savings of over … Read the rest

Childrens’ Toy Aqua Dots Recalled for Containing a Chemical That When Eaten Converts Into “Date Rape Drug”

Aqua Dots, a/k/a Aqua Beads, a Chinese-made toy, was recalled Wednesday, November 7, 2007, by the Consumer Product Safety Commission after two children in the United States and three in Australia were hospitalized after swallowing the beads.

Aqua Dots are packets of brightly colored beads that children arrange into mosaic designs. When sprinkled with water, the beads then stick together in as little as 10 minutes to form durable artworks. The toy was pulled from shelves after scientists found they contain a chemical that converts into a dangerous, potentially fatal drug when eaten. The chemical coating on the beads, when … Read the rest

FDA Warns Off-Label Prescription of Painkiller Fentora Can Cause Death and Life-Threatening Side Effects

The Food and Drug Administration issued a warning today about the risk of potentially fatal overdoses with Fentora, a narcotic painkiller manufactured by Cephalon. The action comes less than two weeks after the company sent a letter to doctors notifying them of three drug-related deaths.

The FDA has received reports of death and life-threatening side effects in patients who have taken Fentora. The reported deaths were the result of improper selection of patients, dosing, or improper product substitution, according to the FDA. One of the deaths was a suicide.

Last October, the FDA approved Fentora for use in cancer patients … Read the rest