Doctor Pleads Guilty to Illegal Distribution of Opioids Resulting in Overdose

A doctor in Manhattan pleaded guilty early in December to illegally distributing fentanyl and oxycodone to patients who did not medically require it. As a result, at least one of his patients is dead from an overdose, having been prescribed hundreds of times the amount of oxycodone generally prescribed for medical purposes. The doctor, who worked for a major Manhattan … Read the rest

New Report Shows FDA Failed to Adequately Address Opioid Crisis

A new report by researchers at Johns Hopkins University shows that the Food and Drug Administration (FDA) failed to adequately address the opioid epidemic that has caused enormous suffering throughout the United States. The documents show the FDA failed to appropriately conduct oversight of the pharmaceutical industry and did not adequately train doctors to handle opioids and the associated risk … Read the rest

Purdue Proposes Settlement for Opioid Suits in Bankruptcy Court

Purdue Pharma LP, one of the largest manufacturers of opioids in the United States, recently filed for bankruptcy in New York amidst a bevy of lawsuits related to the sale and marketing of opioid medications. Its now-former owners, the Sackler family, have been accused both individually and as Purdue’s board members of deliberately pushing its prescription painkillers, thus aggravating an … Read the rest

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