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

Invokana’s Side Effects Put Users at Risk

Recently, an Illinois couple filed a lawsuit in the U.S. District Court of New Jersey, Trenton Division against Jassen Pharmaceuticals and its parent company, Johnson & Johnson, claiming that the use of Invokana caused a stroke. According to Invokana, the medication (Canagliflozin), when used along with diet and exercise, is proven to significantly lower blood sugar (A1C) in adults with type 2 diabetes. Since the launch of the treatment, many Invokana lawsuits have been filed, citing dangerous side effects, including diabetic ketoacidosis (DKA), heart problems, kidney damage, kidney stones, urinary tract infections, stroke, coma and death. Those who have … Read the rest

New York Department of Health Fails to Enforce Nursing Home Fines

New York has approximately 631 nursing homes, where the majority of residents are senior citizens.  The New York Department of Health (DOH), under Governor Cuomo’s Administration, oversees the state’s nursing homes to make sure regulations are followed, and is the enforcement agency when it comes to violations.

Recently, New York State Comptroller Thomas P. DiNapoli announced the results of the state audit. The DOH has not been consistently enforcing fines for nursing home violations, in some cases delaying for up to six years from the citation date to when the fine is imposed.  Although DOH properly conducted surveys under … Read the rest

Recall of Infant and Children’s Liquid Tylenol, Motrin, Zyrtec, and Benadryl: FDA Provides Advice to Consumers

Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Some of the manufacturing deficiencies include products that may contain a higher concentration of active ingredient than specified; others that contain inactive ingredients that may not meet internal testing requirements; and others that may contain tiny particles.

Parents and caregivers are advised by the U.S. Food and Drug Administration to stop using these products. Instead, there a number of other products on the … Read the rest

Michael Moores CAPITALISM: A LOVE STORY in Action: The FDA’s Approval of Menaflex

Last week, just one week before the opening of Michael Moores new movie, Capitalism: A Love Story, the U.S. Food and Drug Administration (FDA) admitted what has been known for a while that its approval of the Menaflex device in December 2008, came after intense political pressure from politicians made just months after they received significant campaign contributions from the manufacturer of Menaflex.

In issuing its approval, the FDA overrode the agency’s scientific reviewers who repeatedly and unanimously over many years decided that the device was unsafe because the device often failed, forcing patients to get another operation. This was … Read the rest

Should Television Ads for Chantix Be Required to State That Its Side Effects are the Subject of an FDA Black Box?

Yesterday morning an advertisement for smoking cessation drug Chantix came on my television. The ad featured a man extolling how much better his life is now that Chantix (and support, slips in the ad) has helped him kick his smoking habit. Then an announcer came on and read, for what seemed like an extraordinary time for the disclaimers usually heard on drug commercials, a litany of side-effects and warnings. These warnings included suicidal thoughts, personality changes, and skin rashes. The announcer did not state, however, that many of the side-effects announced are the subject of a FDA-mandated black box … 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

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