Zometa, Reclast and Boniva infusions have been linked to a rare inflammatory eye disease, according to a letter published in the “New England Journal of Medicine” (NEJM).  The Australian doctors who authored the letter wrote that infusions of these drugs should be “used with caution, or avoided altogether, in patients with acute ocular inflammation or a history of inflammatory eye disease or uveitis.”

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…)

Epoetin alfa, an anemia drug sold in the U.S. as Procrit and Epogen, is being reviewed by federal regulators after patients in a German stroke study treated with the drug died at a higher rate than those administered a placebo.  The Food & Drug Administration (FDA) said it will be receiving more data about the German epoetin alfa trial in the next several weeks.  Once that data has been analyzed, the FDA will communicate its conclusions and recommendations regarding this drug to the public.

Procrit and Epogen are known as erythropoiesis-stimulating agent (ESA).  They are made by Amgen, but Procrit is sold by Johnson & Johnson subsidiary Ortho Biotech under a licensing agreement. ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells.  Procrit and Epogen are approved in the U.S. to treat anemia in cancer patients undergoing chemotherapy. (more…)

Hurricane Ike victims in Texas are reportedly facing long waits for meetings with insurance adjusters.  Adjusters are apparently being hindered by the shear number of claims, areas that are still inaccessible and properties with damage so extensive that they require multiple inspections.  Many Hurricane Ike policy holders are understandably anxious to have their insurance claims settled so that they can begin rebuilding their lives.  But it is important that anyone with a Hurricane Ike insurance claim understand their rights and responsibilities so that in addition to having their claim paid quickly, it is also paid fairly.

According to Texas law, insurance companies usually have 15 days to start investigating a claim once a policyholder lets them know about it. But when a natural disaster strikes, the state’s insurance department can extend that deadline by 30 days. That was done on Wednesday.  Insurers can take as long as they need to investigate claims, such as sending adjusters and inspectors out to examine damages and collecting reports.  Once an investigation is complete, insurance  companies have  30 days to decide whether to pay a claim from a natural disaster, compared to 15 days in a non-disaster situation.  If the claim is accepted, the company has five days to make the payment.  If an insurance company doesn’t meet these deadlines, the state can impose fines. (more…)

Yesterday we reported that the E. coli strain that had sickened students at Michigan State University (MSU) was linked to at least eight other cases in that state, including one at the University of Michigan (U-M) and five at the Lenawee County Jail.  Now, the state Department of Community Health is reporting that the strain is now being linked to at least 13 other cases statewide.  While investigators believe all the patients fell ill from the same food source, the source remains unidentified.  “The problem is that we still don’t know what the source is,” said James McCurtis, spokesman for the Michigan Department of Community Health.  Public health officials believe the eight confirmed infections at MSU may have come from contaminated food delivered to the campus.

Of the eight MSU students, five share a common DNA fingerprint with five cases that emerged out of the Lenawee County Jail, three in Macomb County, and one case each in Washtenaw, St. Clair, Wayne, Oakland, and Kent counties.  According to Dean Sienko, medical director of the Ingham County Health Department, the common DNA fingerprint “strongly suggests that those are part of the same outbreak.”  There are also an additional 21 probable cases at MSU, Sienko said. (more…)

Visits to strip clubs, undeserved patent royalties, and lavish trips are just a few of the illegal incentives Medtronic allegedly furnished to spine surgeons, a federal lawsuit filed by a former company lawyer claims.  According to The Wall Street Journal, the lawsuit charges that Medtronic used the perks to encourage spine surgeons to use its spinal products, including its Infuse Bone Graft.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.   (more…)

A study conducted by University of California, San Francisco (UCSF) researchers states that selective reporting of drug clinical trials may bias comparisons to other medications.  The researchers also state that over half of all supporting clinical trials for U.S. Food and Drug Administration (FDA)-approved drugs have remained unpublished as long as five years after permission has been granted to sell those drugs in the United States. Study findings were published in the journal PLoS Medicine.

As part of their research, the team reviewed medical literature to determine the publication status of all 909 clinical trials that supported the 90 new drug applications that were approved by the FDA in the years between 1998 and 2000.  The group found that 76 percent of all key trials—for example, large Phase II and Phase III trials, which are designed to determine a drug’s overall risks and benefits—were published in medical journals, usually within three years of FDA approval of the drug.  Interestingly, less than half—only 43 percent—of all supporting trials submitted to the FDA were published. (more…)

The European Medicines Agency wants to raise awareness of a deadly brain infection associated with the drug Tysabri.  It recommended Thursday that the product information for Tysabri (natalizumab) be updated to include more information about the risk of progressive multifocal leukoencephalopathy (PML).

PML attacks the brain and central nervous system and is usually fatal.  It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. People with a weakened immune system or people taking drugs that suppress their immune system (immunosuppressants) are most likely to get the disease. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. (more…)

New Zealand is reporting that one of China’s most popular candies—typically sold at Asian markets in the United States—contains dangerous levels of melamine, a toxic industrial chemical.

Melamine is a trimer of cyanamide; a metabolite of cyromazine, a pesticide; and is a major component in Pigment Yellow 150, an ink and plastics colorant.  Melamine is used to create thermosetting plastics, fertilizers, fire retardants, cleaning products, countertops, dry erase boards, fabrics, glues, housewares, and high-resistance concrete.  Melamine is also used to reduce water contents in concrete to make it longer lasting and more flexible.  Most notably, melamine has made the news on a number of recent occasions because of its ability to seemingly increase protein contents in food, especially foods such as watered-down milk products, which has been the case in the extensive and ongoing contamination scandal in China, in which several babies have died and 53,000 children have been sickened.  Studies confirm that ingestion of melamine may lead to reproductive damage, bladder stones, kidney stones, and bladder cancer. (more…)

A study of Paxil has found that the it – and possibly similar antidepressant – could damage fertility in some men.  According to the study, conducted by scientists at Cornell Medical Center in New York, men who took Paxil for four weeks sustained damage to the DNA in their sperm.

Paxil – known generically as paroxetine – was brought to market by GlaxoSmithKline in 1992, and by 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.  Paxil is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Paxil has already been linked to an increased risk of birth defects, as well as suicidal behavior in children and teenagers.  Studies have also shown that women taking SSRIs are more likely to have a low birth weight baby. (more…)

n the midst of yet another tainted food scandal in China, it has been revealed that one of China’s largest dairy producers received consumer complaints about its baby milk formula as early as December 2007.  This is much earlier than previously thought and 10 months prior to the producer ordering a nationwide recall over concerns its formula was sullied with melamine, a toxic industrial chemical.  The disclosure was made in a government report made public by China’s official Xinhua News Agency and is yet another indication that Sanlu Group, the dairy producer at the epicenter of this massive scandal, repeatedly attempted to hide information about its contaminated supplies.  Although the report did not specify the nature or number of complaints, it did place the timing at significantly earlier than when first reported.

The melamine-tainted powdered milk formula has sickened over 53,000 infants and killed three children nationwide, according to the Health Ministry.  The illnesses and deaths led to recalls of Chinese-made dairy products in China and other parts of Asia, which has devastated China’s huge dairy industry and has added to ongoing concerns about the quality of food and consumer products made in China. (more…)