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FDA Says Medtronic Catheter Alert Now a Class I Recall

A health alert issued in June by Medtronic regarding problems with catheters used with its implantable intrathecal drug pumps has been deemed a Class I recall by the  Food & Drug Administration (FDA), the agency’s most serious type.  Medtronic says it has received 83 reports of infusion system difficulties worldwide that have been attributed to either an occlusion or a disconnection of the sutureless catheter from the pump. In one case, a patient died from acute baclofen withdrawal related to complications from an improperly connected catheter.

Neither the June health alert  nor the FDA’s classification Friday called on patients to have devices removed, and hospitals and doctors are not being asked to return unused products.   However, patients who experience the catheter problems described in the recall will require a surgical procedure for correction, Medtronic said. (more…)

FDA Recalls Mr. Brown Instant Coffees and Milk Teas as Chinese Melamine Problems Spread to U.S.

The Food & Drug Administration (FDA) said today that China-made Mr. Brown instant coffee and tea products were being recalled amid concerns that they are contaminated with melamine.  China has been dealing with a scandal over melamine-tainted dairy products for weeks, but this is the first time they have been involved in a U.S. recall.

So far, the FDA has said no milk-based imports from China have tested positive for melamine contamination.  But the agency is  recommending that U.S. consumers not consume any of the recalled Mr. Brown instant coffee and milk tea products.  The FDA is also telling retailers and foodservice operators to remove the products from sale or service. The recall includes seven Mr. Brown products: (more…)

Bisphosphonate Infusions Linked to Inflammatory Eye Disease

 A letter in the New England Journal of Medicine says that Boniva,  Zometa and Reclast infusions caused inflammatory eye disease in four patients.  Inflammatory eye disease is only the latest side effects to be associated with these drugs, and others in their class.

Zometa, Reclast and Boniva are part of a class of drugs known as bisphosphonates, which also includes Fosamax, Didronel, Boniva, Aredia, Actonel, and Skelid.  They were first approved by the Food & Drug Administration (FDA) to reduce the risk of bone fracture and to increase bone mass in people with osteoporosis.  Bisphosphonates are also administered via infusion to slow bone turnover in people who have cancer that has spread to their bones, and to lower excessive levels of calcium in the blood in some people with cancer.  Bisphosphonates are also used to treat Paget’s disease of bone. (more…)

Procrit and Epogen Subject of FDA Safety Review Following Deaths in German Study

The Food & Drug Administration (FDA) says it is reviewing the safety of Procrit and Epogen after another brand of epoetin alfa was associated with higher death rates among patients in a German stroke study. Procrit and Epogen are known as erythropoiesis-stimulating agent (ESA) and are approved in the U.S. to treat anemia in cancer patients undergoing chemotherapy. They are made by Amgen, but Procrit is sold by Johnson & Johnson subsidiary Ortho Biotech under a licensing agreement.

The German study involved a version of epoetin alfa called Eprex, made by Johnson & Johnson, which is not marketed in the U.S. According to the FDA, Johnson & Johnson  made it aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.  Treatment of anemia was not a goal of the trial and most patients were not anemic. (more…)

Peripheral Artery Disease in Women Tied to Second-Hand Smoke

A new study has found that non-smoking women exposed to second-hand smoke face a higher risk of peripheral artery disease (PAD) than those who do not experience such exposure. “This study broadens the finding about the detrimental health effects of passive smoking on heart disease and stroke,” senior author Frank Hu, a professor of nutrition and epidemiology at the Harvard School of Public Health, said in a news release issued by the American Heart Association. While the study focused on women, Hu said it’s likely that secondhand smoke exposure affects men in the same way.

For the study,  conducted by researchers at the Chinese PLA General Hospital in Beijing, secondhand smoke exposure was defined as exposure to tobacco smoke for at least 15 minutes daily for more than one day every week for at least two years during the past 10 years. (more…)

Study Finds Higher Stroke, Heart Attack Risks With Spiriva, Atrovent

A new study indicates that the COPD (chronic obstructive pulmonary disease) drugs such as Spiriva and Atrovent can increase heart attack and stroke risks by 58 percent. Spiriva and Atrovent are known as inhaled anticholinergis, and are used daily by people with COPD to ease breathing.

“In absolute terms, what it means is that if you were to use these drugs for a year, your absolute risk of developing an additional cardiac death would be one in 40,” Dr. Sonal Singh, assistant professor of internal medicine at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., told “US News and World Report”.  Dr. Singh was lead  author of an article detailing the study that appeared in the Sept. 24 issue of the “Journal of the American Medical Association”. (more…)

Study Raises Questions About Artificial Sweetener, Splenda

A new study conducted at Duke University has linked the artificial sweetener  Splenda to health problems. The release of the study has already prompted one consumer advocacy group to call on federal regulators to take a look at Splenda, but the maker of the popular sweetener is dismissing the study’s findings because it was funded by a group that lobbies for the sugar industry.

The Duke University Splenda study was posted today on the  Journal of Toxicology and Environmental Health website. The study was conducted using male rats over a period of twelve weeks. The researchers found evidence that, in the animals studied, Splenda reduced the amount of good bacteria in the intestines by 50%, increased the pH level in the intestines, contributed to increases in body weight and affects the P-glycoprotein (P-gp) in the body in such a way that crucial health-related drugs could be rejected. (more…)

Excessive Use of Denture Cream Could be Dangerous

Another denture product has been linked to health problems.  According to researchers at the University of Texas Southwestern Medical Center in Dallas, excessive amounts of  denture cream can cause neurological problems because they contain zinc.

Last March,  the Food & Drug Administration (FDA) said one person had died and at least 72 others were sickened as a result of allergic reactions to denture cleaners.  The FDA blamed a bleach called persulfate, an allergen that is used in most denture cleansers, for the reactions. In many cases, patients suffered an allergic reaction after swallowing the cleaner, which is not recommended.  The agency FDA asked manufacturers of denture cleansers to include a warning in the label about persulfates.  (more…)

Revlimid Linked to Skin Disorders

The Food & Drug Administration (FDA) says 14 cases  – including 3 deaths – of Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been seen in patient treated with Revlimid.

Stevens-Johnson Syndrome is a hypersensitivity complex affecting the skin and the mucous membrane.  The disorder causes blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash.  Toxic epidermal necrolysis presents with a similar blistering of mucous membranes. However, in addition to blistering, the entire epidermis peels off in sheets from large areas of the body. Both disorders can be life threatening. (more…)

Leukemia Risk Seen with Unapproved Use of Phosphocol P 32

Unapproved use of the cancer drug Phosphocol P 32 has been tied to two cases of leukemia in children. Phosphocol P 32, made by Covidien Ltd.,  is  approved to treat fluid leaking in the lungs or abdominal cavity caused by spreading diseases such as cancer or infection. Covidien has added information about the leukemia cases to the “Warnings” section of the Phosphocol P 32 label.  In addition, “leukemia in children” is now noted as a risk in the label’s “Adverse Events” section.

In a letter sent to doctors informing them of the labeling changes, Covidien  said that the “Adverse Events” section of the Phosphocol P 32 label has  also been updated to include information about post-marketing reports  that showed patients experienced radiation injury to the small bowel, bladder and part of the large intestine known as the cecum following administration of the drug. (more…)

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