The 8th annual national MEDMARX(R) Data Report released last month by the U.S. Pharmacopeia (USP) revealed that more than 1,400 commonly used drugs are involved in errors linked to drug names that look alike or sound alike. USP’s review revealed a near doubling since 2004 of the pairs of drug names that look or sound alike, from 1,750 pairs to 3,170 pairs.
According to findings in the MEDMARX report, 1.4% of the errors resulted in patient harm, including seven errors that may have caused or contributed to patient deaths. Medication errors are often the basis of medical malpractice cases.… Read the rest
The U.S. Food and Drug Administration (FDA) on February 1, 2008, issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.
Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. Chantix has been suggested as being a possibly significant contributing factor to the bizarre and tragic death of musician Carter Albrecht on September 5, 2007.
The FDA action adds credibility to the belief that Chantix … Read the rest
Merck and Schering- Plough, the makers of the popular cholesterol drug, Zetia, announced that Zetia and Vytorin, a pill containing Zetia and Zocor, had failed to benefit patients of a two-year trial which was completed in April of 2006. Merck and Schering-Plough’s press release stated that Zetia not only failed to slow down the accumulation of fatty plaque in the arteries, it contributed to the formation of plaque. Patients taking Vytorin to reduce the growth of fatty plaque in the arteries actually experienced a growth of plaque in their arteries twice as fast as those taking Zetia alone.
This … Read the rest
Pursuant to the terms of the $4.85 billion Vioxx settlement, January 15, 2008 is the deadline for all plaintiffs with a Vioxx-related case to register — whether or not their injuries would necessarily qualify for the settlement payout. This preliminary step will establish how many cases Merck, the manufacturer of Vioxx, faces. Those that don’t qualify for the settlement could still go to court. More than 28,000 of the estimated 60,800 claimants have submitted registration information so far.
But several plaintiffs attorneys have made a motion requesting that the federal judge overseeing the Vioxx settlement, U.S. District Judge Eldon … Read the rest
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
On June 27th, a Senate hearing was held regarding the pharmaceutical industry’s routine practice of promoting and marketing drugs and medical devices by showering doctors with gifts. Drug companies which attempt to persuade doctors to prescribe their drugs provide doctors with meals at high-priced restaurants, stock options, sponsorships for educational programs, drug samples, tickets to sporting events and Broadway shows, lab professorship funding, and trips to educational conferences at popular vacation areas with airfare, car rental, and hotel costs included.
Senator Clair McCaskill, Missouri Democrat, and Senator Herb Kohl, Wisconsin Democrat and chairman of the Special Committee on Aging, … Read the rest
The news last week was filled with various reports concerning the manner in which pharmaceutical manufacturers market their products, such as OxyContin, anemia medicines, and atypical psychotics, including ways in which doctors are encouraged to prescribe their products, even to children. The U.S. Senate passed, by a vote of 93-1, a bill that gives the Food and Drug Administration additional authority to regulate drug advertising, among other powers such as the ability to order changes in drug labels.
The bill was passed in large part as a reaction to the experience with Vioxx, where it took 14 months to change … Read the rest