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 hospital, will be sentenced in March, and faces a maximum of twenty years in prison.

Opioid addiction has become an increasingly common problem throughout the United States, with many who become addicted dying from an overdose. While this spread of … 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 of addiction. These failures contributed to the rise of opioid addiction in the United States, which kills around 72,000 people per year.… 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 opioid crisis that is estimated to kill approximately 130 people every day in the United States. Purdue’s attorneys have proposed a settlement that would resolve the thousands of suits currently pending against them, as well as resolve a federal inquiry … 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 highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal ideation and behaviors when taking these drugs.

The FDA has received additional information bolstering the suggestion of a possible association between both varenicline … 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 permanent. In addition to a loss of the sense of smell, patients have also complained of a loss of the sense of taste. The FDA has received more than 130 reports of loss of sense of smell associated with the … 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 coffee mug to a solicitation for donations has been shown to significantly increase donations. These types of gifts can also influence prescribing behavior, according to a study that appears in The Archives of Internal Medicine. (Arch Intern Med. 2009;169(9):887-893).

The … 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 alpha-blocking drug that accounted for more than $1 billion in sales in 2007.

This BPH/cataract combination is dangerous: A study to assess the risk of adverse events following cataract surgery in older men prescribed Flomax found that exposure to tamsulosin … 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 for grades six through twelve.

One of Channel One’s drug ads links to Acneheroes.com, a kid-targeted website created by the pharmaceutical company Sanofi-Aventis to promote BenzaClin, a prescription drug for acne. The website features actor Cody Linley, who introduces himself … 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 packs.

This action was taken subsequent to the U.S. Food and Drug Administration’s April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.

Limited … 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 adequately warn consumers about the potential dangers of receiving a stent, including a ruptured coronary artery. The ad does warn of heart attack and stroke.

The ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, … Read the rest