New York City Personal Injury Lawyer - Defective Drugs

Certain Zicam OTC Products Recalled

Chrissie Cole — Wed, 17 Jun 2009 20:33:00 GMT

The U.S. Food and Drug Administration (FDA) is warning consumers to avoid using certain over-the-counter Zicam products, after receiving 130 reports of loss of sense of smell associated with use.

Many Zicam users who experienced loss of sense of smell, also known as anosmia, said the condition occurred with the first dose; while others reported a loss of smell after multiple uses.

The affected Zicam products are:

--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

Anosmia, can adversely affect a person’s safety by limiting their ability to detect the smell of gas, spoiled food or smoke and other dangers in the environment.

“We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).

In a letter to Matrixx Initiatives, the maker of Zicam products, the agency said the company must cease marketing the products because they are misbranded and fail to warn users of the risks associated with use.

Zicam users that have experienced loss of smell or other problems associated with these products are advised to contact their health care professional.

Originally posted at InjuryBoard by Chrissie Cole

Three Deaths Linked To Psoriasis Drug Raptiva

Chrissie Cole — Fri, 20 Feb 2009 12:05:00 GMT

The FDA has confirmed three reports of death from progressive multifocal leukoencephalopathy (PML) associated with the Psoriasis drug, Raptiva. A fourth case is being looked at as well.

PML is a rare and often-fatal brain infection, where there is inflammation of the brain's white matter. Patients with a severely compromised immune system are at risk of suffering from an irreversible brain function and possibly death. No treatment exists for PML.

Psoriasis is a chronic and painful skin disorder characterized by inflamed, red, scaly lesions, caused when affected skin cells reproduce faster than normal. Certain forms of psoriasis may be fatal.

Raptiva’s product labeling was revised in October 2008 to include a boxed warning about the risks of life-threatening infections associated with the drug, including PML.

Genentech, the manufacturer, was directed by the agency at that time to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide intended to educate patients about the drug’s associated risks.

The agency advises health care professionals to carefully monitor patients taking Raptiva for any sign of neurologic disease.

In September 2008, the drug Rituxan, also manufactured by Genentech, revised its labeling after a woman who was treated with it died from PML, according to the U.S. Food and Drug Administration (FDA).

Originally posted at InjuryBoard by Chrissie Cole

Genetech Updating Rituxan Label After Patient Death

Chrissie Cole — Mon, 15 Sep 2008 14:24:00 GMT

Genetech notified healthcare professionals of revisions to the prescribing information on the drug Rituxan after a woman who was treated with it died from a brain infection, according to the Food and Drug Administration (FDA).

Progressive multifocal leukoencephalopathy (PML) is a rare and often-fatal brain infection, where there is inflammation of the brain's white matter.

The drug was first approved by the FDA in 1997 to treat non-Hodgkin’s lymphoma and in 2006 for the treatment of rheumatoid arthritis.

According to the FDA, this is the first reported case of infection in a patient taking Rituxan for the treatment of arthritis. PML cases have been linked to patients taking Rixutan for unapproved uses in the past, including blood cancer.

Biogen Idec first reported the fatal case of PML in July.

Originally posted at InjuryBoard by Chrissie Cole

Regranex Use May Increase Risk of Cancer

Chrissie Cole — Sun, 30 Mar 2008 20:44:20 GMT

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 patients who are at least 19 years of age, with no history of cancer and prescribed Regranex or not.

While there is not conclusive evidence at this time to decide there is an increase in the number of patients that develop cancer, there is considerable danger to diabetics leaving foot ulcers untreated. The potential risks of using Regranex should be considered against the benefits.

The FDA suggests patients discussing the pros and cons of Regranex use with their medical doctors.

Originally posted at InjuryBoard by Chrissie Cole

FDA Issues Alert on Tussionex

Chrissie Cole — Tue, 11 Mar 2008 00:37:07 GMT

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 of age and older.

"There is a real and serious risk for overdosing if this medication is not used according to the labeling," said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. "Today's action is an example of the FDA working with drug manufacturers throughout a product's lifecycle to keep health care professionals and patients informed of new safety data."

Adverse events reports associated with Tussionex include life threatening side effects and death in patients, including young children.

The reports also revealed that doctors are at times prescribing the drug, and patients are at times staking more than the recommended dosage or taking the medication more frequently then recommended.

Originally posted at InjuryBoard by Chrissie Cole

FDA Warns of Contaminated Syringes

Chrissie Cole — Fri, 25 Jan 2008 00:38:43 GMT

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 linked to blood infections, urinary tract and wound infections and pneumonia.

The FDA advises all consumers and health care facilities to stop using the recalled products immediately. Consumers should return the products to the location in which they were purchased. Health care facilities should return the recalled products to their distributor.

The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections.
The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.

Originally posted at InjuryBoard by Chrissie Cole

Antidepressants Have Little Effect

Shannon Weidemann — Sun, 20 Jan 2008 10:23:05 GMT

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 positive, and all but one were published, the report said.
But of the 36 studies found to have negative or questionable results by the FDA, 22 were not published. And of the 14 that were published, researchers said at least 11 "mischaracterized" results by putting a positive spin on them, the report said.

Many doctors review these reports in order to decide on the best course of treatment for their patients. Critcs argue that doctors are not receiving all sides of the data.

If you would like to learn more about prescription drugs, please visit InjuryBoard's Prescription Drug information page.

Originally posted at InjuryBoard by Shannon Weidemann

Trasylol License Suspended

Shannon Weidemann — Fri, 21 Dec 2007 12:01:53 GMT

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 basis of preliminary findings from a clinical trial (the BART study), which was stopped early after excess mortality was observed in the aprotinin arm compared with the tranexamic acid and aminocaproic acid arms (relative risk 1.5).

Trasylol has been used around the world in open heart sugeries to reduce bleeding complications. It has been linked to kidney failure, heart attack and stroke. There have been several recent studies questioning the safety of Trasylol.

If you would like to learn more about Trasylol, please visit our Trasylol information page.

Originally posted at InjuryBoard by Shannon Weidemann

Sierra Heparin Syringes Recalled

Shannon Weidemann — Wed, 19 Dec 2007 21:54:04 GMT

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 turned up only in Illinois and Texas, said Dr. Arjun Srinivasan of the federal Centers for Disease Control and Prevention.
The infections can cause fever and chills. They can be serious but generally respond well to antibiotics.

The lot number on the recalled items is 070926H. If you believe that you have the affected pre-filled syringe you should contact your doctor or local health department for more information.

If you would like to learn more about recalled drugs, please visit InjuryBoard's FDA & Prescription Drugs information page.

Originally posted at InjuryBoard by Shannon Weidemann

HPV Vaccine Linked to Paralysis

Shannon Weidemann — Wed, 14 Nov 2007 21:48:35 GMT

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 family is very upset and is looking for answers.

Cronin says he can't go after Merck with a lawsuit because Gardasil is now part of a federal fund which pays out to those injured from vaccines.
First Coast News has learned, Gardasil was added to the National Vaccine Injury Compensation Fund just months after it hit the market. "The Federal government would not put it on the list without medical scientific justification," says Cronin.

The girl has been undergoing physical therapy in the hopes that she will regain feeling in her leg and be able to resume her favorite activities.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Shannon Weidemann