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Heart Surgery Drug Trasylol Withdrawn from Market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

“Stop-Smoking” Drug Chantix May Have Caused Psychotic and Suicidal Behavior Leading to Death of Musician

Concerns have surfaced that Chantix, the stop-smoking drug manufactured by Pfizer, may have led to musician Carter Albrecht’s bizarre and tragic death on September 5, 2007. That rare psychotic and suicidal behavior are possible side effects of Chantix is mentioned in extreme fine print of the original box insert. However, large-print, pharmacy handouts given to users of the drug warning of nausea, changes in dreaming, constipation, gas, and vomiting with the use of Chantix do not mention rare psychotic and suicidal behavior.

Albrecht was keyboard player from pop-music group Edie Brickell and the New Bohemians. Albrecht was also a singer, … 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

New York City and New York State File Suit Against MERCK Alleging Medicaid Fraud

Both New York City and New York State have joined together and, following the example of various other states, including Louisiana Mississippi and Utah, have filed suit against Merck& Company.

It is alleged that Merck not only defrauded consumers but also defrauded the state Medicaid program and other government insurance programs by purposefully concealing the dangerous side effects of Vioxx.

Vioxx was prescribed to patients for the treatment of migraines and arthritis but caused a high increase in heart attacks and strokes, and was pulled off the market in September of 2004.

Medicaid claims that had Merck been forthcoming of … Read the rest

FDA’s Rule Pre-empting State Law Failure-to-Warn Claim is Rejected

On July 3rd, the Vioxx multidistrict litigation court held that the Food and Drug Administrations (FDA)’s rule preempting state products liability law suits against drug companies in failure-to-warn claims is not persuasive. The court also stated that FDA cannot assume that Congress intended to override the long-standing presumption against preempting state law.

The court’s ruling is a victory for consumers injured by medicines that they claim are inaccurately labeled. Though issued in litigation pertaining to Vioxx, the ruling may also end up being applied to Avandia as cases are brought and move forward.

The FDA’s preemption theory is found in … Read the rest