Latest News

Heart device recall poses a quandary for patients

On Sunday when Medtronic warned physicians to stop using a potentially faulty wire attached to its heart defibrillators, the company also advised patients to consult their doctors. On Monday, anxious patients were doing just that, causing some doctors’ offices to be flooded with calls as people tried to determine whether they might have the defective models. The risk of a defective wire is low. Medtronic said that about 2.3 percent of the estimated 235,000 patients with the defective wire, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. But learning through tests that one’s ... Read More

MRI contrast agents get strong kidney-risk warning

Certain contrast agents used in magnetic resonance imaging — gadolinium-based products made by Bayer AG, GE and others — will now carry the U.S. Food and Drug Administration’s strongest, “black box” warning. The FDA’s move on Friday finalizes its announcement in May that it would add the labeling warning to the MRI contrast agents. The final warning notes that the agent boosts the risk of a potentially fatal side effect in patients with certain kidney and liver conditions. The skin disease called nephrogenic systemic fibrosis, or NSF, can occur in some patients, the companies said in a joint letter to ... Read More

MRI Gadolinium contrast agents get black box warning

The U.S. FDA indicated that it would start adding its strongest ‘black box’ warnings to gadolinium based contrast agents used in MRIs by May of next year. There are five different types of gadolinium based contrast agents, and the FDA has evidence enough to suggest a causal connection between the agents and a skin condition called nephrogenic systemic fibrosis (NSF) in patients with impaired kidney function. NSF normally begins from days to several months after the exposure to the contrast agents, and results in the thickening and tightening of the skin. Skin may become spotted and may be accompanied by ... Read More

Drug industry seeks tests to spot side effect risks

Seven major pharmaceutical companies are banding together to develop genetic tests that predict which patients will have adverse side effects from drugs. The group, a nonprofit organization dubbed the International Serious Adverse Events Consortium (SAEC), will conduct two studies, one to look at drug-related liver toxicity and the other aimed at a rare drug-related skin condition called Stevens-Johnson syndrome. “SAEC’s focus is to identify and to validate DNA variance or genetic markers that are useful in predicting a drug-induced serious adverse event,” Arthur Holden, the chairman of the group, said during a midmorning teleconference Thursday. The findings of the consortium ... Read More

Natural menopause

Oestrogen and progesterone are necessary hormones for reproduction which are produced naturally by a woman’s ovaries. At around the age of 50 the body slows down and eventually stops production of these hormones, which brings on the menopause or ‘change of life’. The menopause is, strictly speaking, the moment when a woman no longer has menstrual periods, but the term is generally used to describe the years leading up to and after that time. For some the menopause can be uncomfortable and distressing. Symptoms can include: hot flushes, night sweats, palpitations, vaginal dryness, urinary tract infections, depression, mood swings, weight ... Read More

Cause of debilitating skin condition suggested

New findings from researchers at Wake Forest University Baptist Medical Center and colleagues suggest why some people with kidney failure can develop a rare tightening and swelling of the skin and other organs, including the lungs and heart. Reporting in the October issue of the American Journal of Dermatopathology, the authors suggest a possible explanation for why some patients on kidney dialysis who are injected with a “contrast agent” during a magnetic resonance imaging (MRI) develop nephrogenic systemic fibrosis (NSF). The U.S. Food and Drug Administration now requires a warning about the potential risk on the products’ labels. NSF leads ... Read More

Gadolinium based contrast agents more common and deadly than previously thought

Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NFD), a painful conditions that has been linked to the use of gadolinium based contrast agents used in Magnetic Resonance Imaging (MRI), could be more prevalent than once thought. A recently released study also found that kidney patients with NSF/NSD are far more likely to die than those without the disorder. NSF/NFD, a disease that affects people with pre-existing kidney disease, leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or ... Read More

Wyeth must pay $134.1 million in menopause drug lawsuit

Wyeth must pay $134.1 million, including $99 million in punitive damages, over its mishandling of menopause drugs that helped cause three Nevada women’s cancers, a jury ruled. The panel ruled Oct. 12 that the company owed the women $35.1 million in compensatory damages. Jurors in state court in Reno concluded today that Wyeth, the largest maker of hormone- replacement medicines, should also pay Arlene Rowatt, Jeraldine Scofield and Pamela Forrester punitive damages for concealing the breast-cancer risks of its Prempro and Premarin drugs. “We got the word out that a lot of women have been injured by this type of ... Read More

Kugel Mesh patients not out of the woods yet

Rockville, MD: Just because the Kugel Mesh Patch was recalled over a year ago does not mean that adverse event reports regarding the hernia patch are no longer being submitted to the U.S. Food and Drug Administration (FDA). In fact, the FDA received numerous reports in August of serious problems with the Kugel Mesh Patch, some of them life-threatening incidents. The reason that people are still suffering serious complications from the hernia patch is that when the recall was announced, doctors were told to weigh the risks of leaving the patch in with the risks of explanting it. Patients who ... Read More

Jury awards 3 women $134.5 million in hormone therapy lawsuit

Reno, Nev., (AP) – A jury has levied a $134.5 million judgment against the pharmaceutical maker Wyeth in a lawsuit filed by three Nevada women who contended that the company’s hormone-replacement drugs had caused their breast cancer. It was the largest award to date against Wyeth, of Madison, N.J., which faces more than 5,000 similar lawsuits across the country in state and federal courts. The panel deliberated for two days before announcing its verdict late Wednesday in favor of Jeraldine Scofield, 75, of Fallon; Arlene Rowatt, 67, of Incline Village; and Pamela Forrester, 64, of Yerington. A Wyeth spokesman, Douglas ... Read More