FDA Requires Boxed Warning on Serious Neuropsychiatric Events for Chantix and Zyban. Is a Ban Next?

The U.S. Food and Drug Administration (FDA) announced on July 1, 2009, that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) and to update the Medication Guides for patients that further discuss the risk of mental health events when using these products. The warning will … Read the rest

FDA Advises Consumers to Stop Using Zicam; Active Ingredient Can Cause Loss of Smell

In a press release dated June 16, 2009, the U.S. Food and Drug Administration (FDA) advised consumers to stop use of three over-the-counter Zicam Cold Remedy products: nasal gel, nasal swabs and the discontinued “kids size” swabs. The FDA’s advisory stated that the products are associated with the loss of sense of smell, called anosmia.

Anosmia may be long-lasting or … Read the rest

It Doesnt Take Much of a Gift to Influence Doctors Prescription Choices

A principal underlying assumption regarding limits on and ethics guidelines addressing pharmaceutical promotion is that smaller gifts are unlikely to exert influence on prescribing decisions. Nonetheless, a substantial body of marketing and psychology literature suggests that even trivial doctor gifts can exert influence irrespective of economic value.

Adding a small gift such as personalized mailing labels, a pen or a … Read the rest

Black Box Warning Label Suggested For Flomax Due to Complications From Cataract Surgery

Cataract surgery is the most commonly performed operation in the United States today, with nearly 2 million cataract operations performed in the United States each year. Benign prostatic hyperplasia (BPH), an enlarged prostate, is common in older men, affecting nearly 3 out of 4 men by the age of 70 years. BPH is often treated with tamsulosin hydrochloride (Flomax), an … Read the rest

They’re Marketing Prescription Medications to Our Children in Our Schools

Advocates for children are upset that Alloy Media and Marketing has run ads for prescription drugs from its Channel One website. Channel One provides free news and original programming to about 10,000 middle and high schools. Channel One is, in the opinion of many, a controversial in-school news program that makes viewing ads a compulsory part of the school day … Read the rest

Medtronic Recalls Selected Heparin-Coated Products

Medtronic, Inc., in what is termed a precautionary measure, has voluntary recalled selected products featuring its Carmeda BioActive surface, a coating applied to some devices used in heart bypass surgery and dialysis, because the coating includes contaminated heparin, a blood thinner that has been linked to 81 deaths. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing … Read the rest

Direct to Consumer Advertising of Cypher Stent Draws Heavy Criticism and Points to Need for Legislation

For several years the U.S. Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Now, a television advertisement for a heart stent, metal mesh devices that are used to prop open arteries after they have been cleared of blockages, has been scrutinized and attacked in an op-ed article for failing to … Read the rest

Governor Paterson Busy Protecting Citizens from Harmful Doctors, Drugs, Toys and Sexual Predators – Part 2

Part 2 of this topic discusses new legislation regarding dangerous drugsdefective toys and sexual predators using the internet to prowl and prey. The information herein is set forth in press releases issued by the governor’s office. Proposed legislation designed to protect patients from medical malpractice was discussed in Part 1 of this blog. Governor David A. Paterson has … Read the rest

Governor Paterson Busy Protecting Citizens from Harmful Doctors, Drugs, Toys and Sexual Predators – Part 1

Last week was a busy week for New York’s Governor David A. Paterson on issues often written about in this blog – medical malpracticedangerous drugsdefective toys and sexual predators using the internet. Some bills were signed, others introduced. The most ambitious of these was on the medical malpractice front, Governor Paterson proposed legislation that offers … Read the rest

Encouraging News? Congress Prepares to Undo Anticipated Supreme Court Decision Precluding Lawsuits Over Dangerous Drugs

In the event that the Supreme Court applies the federal doctrine of preemption to permit the pharmaceutical industry to avoid accountability for the harm dangerous drugs cause, the only remedy would be for Congress to pass a law expressly stating that preemption does not preclude state court lawsuits for compensation.

And that, hopefully, is the goal of the process engaged … Read the rest