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 … 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 … 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 … 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 … 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 … 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

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