New York updates in category: FDA & Prescription Drugs

The U.S. Food and Drug Administration (FDA) has identified 25 drugs and biologic products that will be expected to turn in safety plans called Risk Evaluation and Mitigation Strategy (REMS), the...

The U.S. Food and Drug Administration (FDA) is researching data that shows an increased risk of cancer, in diabetic patients who use Regranex Topical Gel (becaplermin) for the treatment of foot and leg ulcers.The FDA received information from a study that was performed to investigate the possibility of increased cancer risk in connection with use of Regranex.The study was based on diabetic...

The FDA has issued a safety alert regarding the proper use of Tussionex Extended-Release Suspension, a potent long acting prescription cough medication, following several reports of adverse events - including death - associated with inappropriate use.The medication contains hydrocodone (a narcotic) and chlorpheniramine (an antihistamine) and is prescribed for use in adults and children six years...

The U.S. Food and Drug Administration (FDA) announced a nationwide drug recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc. under the brand name(s) Sierra Pre-filled, Inc. and B. Braun. The recall was announced after samples tested positive for Serratia marcescens, a bacterium that can cause death and serious injury. Serratia marcescens has been...

A study in the New England Journal of Medicine is reporting that many antidepressants do not work. The antidepressant study was performed by researchers at Oregon Health and Science University. They based their data on 74 studies that had been submitted to the FDA. The study shows that of the 74 studies registered with the Food and Drug Administration from 1987 through 2004, 38 were deemed...

The FDA is reminding prescibers and patients that certain osteoporosis medications may be associated with severe or incapacitating bone, joint and muscle pain. FDA advises that these side effects may develop days, months or even years after starting the drug and may persist despite stopping the medication. The Food and Drug Administration (FDA) monitors side effects of drugs that are currently...

The anti-bleeding drug Trasylol was recalled in early November after a study revealed the risk of death was 50 percent higher than on other drugs. The BART study examined results on over 3,000 patients that had been given Trasylol and two similar drugs. The Commission on Human Medicine decided this week to suspend Trasylol's license. The CHM decision to suspend the licence was made on the...

Pre-filled syringes manufactured by Sierra Pre-Filled have been recalled after being contaminated with Serratia marcescens. The recalled syringes had sicked approximately 40 people in two states. It is not known if the contaminated item was the syringe or the Heparin contained in them. Syringes from that batch also were sent to Colorado, Florida and Pennsylvania but infections so far have...

The vaccine Gardasil was introduced last year as a way to combat cervical cancer in women. It works by preventing an infection with Human Papilloma Virus (HPV). Now there are reports of girls having adverse affects after receiving the vaccine. One such report is from the family of a 12-year-old girl in Florida that had paralysis in one leg two weeks after receiving the first injection. The...

The blood clotting drug Trasylol will no longer be sold by Bayer AG after studies have shown there is an increased risk of death from using the drug. The recalled drug increases the risk of kidney damage when used during heart bypass surgery. The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA's...

The recent recalls of Chinese products has generated a scare. As consumers in a global economy we all should be concerned with the many reports. of defective products. As citizens we should be concerned with our governments failure to protect us. Lawyers have over the years been the help of last resort for injured consumers. In a global economy seeking compensation from those responsible is a...

The recent recalls of Chinese products has generated a scare. As consumers in a global economy we all should be concerned with the many reports. of defective products. As citizens we should be concerned with our governments failure to protect us. Lawyers have over the years been the help of last resort for injured consumers. In a global economy seeking compensation from those responsible is a...

Dialysis cartridges used in the NxStage's System One portable dialysis machine have been recalled due to potential dialysate leaks. The dialysis machines are used in 265 clinics around the country. After discussing the leakage issue with the U.S. Food and Drug Administration, NxStage said in the SEC filing that it decided on August 24 to physically recall the affected lots of cartridge...

The FDA issued a letter to Eli Lilly requesting more information about their drug Symbyax before approving it for a new use. Symbyax is a combination of Prozac and Zyprexa. Zyprexa is currently the subject of several state-led class action lawsuits due to underreported side effects and marketing of the drug for uses not approved by the FDA. The FDA made its request for more information on...

A Canadian women died in March due to toxic counterfeit drugs she purchased over the Internet. This was the first confirmed Canadian death due to Internet drugs. The women bought the bogus medication from a fake online pharmacy. The drugs she purchased were found to contain high levels of metal.The Executive Director of the Canadian Pharmacists Association (CPhA), Dr. Jeff Poston, is advising...