Today, the U.S. Food and Drug Administration (FDA) requested that SEI Pharmaceuticals of Miami, Florida recall all Xiadafil VIP Tabs sold in eight tablet bottles (Lot # 6K029) or blister cards of two tablets (Lot # 6K029-SEI).  Florida officials issued a “stop sale” action at SEI’s Miami distribution facility on May 13 that required SEI to hold—intact—violative Xiadafil VIP Tabs found on-hand at the facility.

The Xiadafil VIP Tabs contain a potentially harmful, undeclared ingredient found in the prescription drug Viagra that may dangerously affect a person’s blood pressure as well as cause other life-threatening side effects.  The lots of Xiadafil VIP Tabs containing the potentially dangerous ingredient, bear an expiration date of September 2009 (09/09).   Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and claim to treat erectile dysfunction (ED). (more…)

Many former Vytorin patients switched off the expensive drug after a study -called ENHANCE – released earlier this year showed it was no more effective than cheaper statins.  Now it turns out that one of those patients was none other than Republican presidential nominee Senator John McCain.

Vytorin, which was developed and marketed jointly by Merck and Schering-Plough, was approved for use by the Food & Drug Administration (FDA) in 2004. Since it came on the market, Vytorin sales have reached $5 billion per year. Vytorin is a combination of cholesterol-lowering Zetia and the statin Zocor – known generically as simvastatin. Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines. High cholesterol levels put a person at risk of developing clogged arteries – a major risk factor for heart attacks and strokes. Doctors and Vytorin users were led to believe that the drug would effectively reduce both sources of cholesterol, thereby lessening the amount of plaque build up in the arteries, as well as the risk of having heart attacks and strokes. (more…)

Earlier this month, New Jersey state health officials began investigating six confirmed cases of Salmonella at Princeton University to determine if they were related to 70 other cases of stomach illnesses there.  The Princeton Regional Health Department (PRHD) worked with New Jersey state officials to conduct preliminary food history surveys with both infected and healthy students.  Initial data pointed to the Frist Gallery as being a possible source of infection, PRHD health officer David Henry said.  Now, New Jersey health officials are saying that a Salmonella outbreak at Princeton University appears to have been caused by an ill food service worker who touched some shredded cheddar cheese.

The state Health Department says there were 28 confirmed and 42 probable cases of Salmonella infection on campus between April 20 and May 2. 

All the cases appeared to have generated from two food stations at the Frist Student Center. (more…)

Children who lived in toxic Katrina trailers distributed by the Federal Emergency Management Agency (FEMA) could face years of health problems.  The FEMA trailers were filled with toxic formaldehyde fumes, a chemical known to cause cancer and respiratory problems.  Thanks to FEMA’s ineptitude and deception, children spent months – and in some cases years -  in the trailers.  Now health officials around the Gulf Coast are concerned that problems stemming from the dangerous formaldehyde fumes will follow these children for the rest of their lives.

Thousands of people in Mississippi and Louisiana were given FEMA trailers as temporary housing following hurricanes Katrina and Rita. But by 2006 FEMA was getting reports from field workers along the Gulf Coast that residents of FEMA trailers where getting sick from the air in the toxic trailers. The first suspect was formaldehyde, which is used in the manufacture of the trailers. Despite the reports, e-mails uncovered last summer during a congressional investigation into the trailers showed that FEMA lawyers told the agency to drag its feet on air quality testing. FEMA’s Office of General Council also advised the agency not to test the trailers because doing so “would imply FEMA’s ownership of the issue”. (more…)

In a May 1 letter to 10 laboratories, the House Committee on Energy and Commerce writes that the labs may have been encouraged by importing companies to withhold tainted food samples in order to enable foods to reach United States consumers.  The committee asked 50 multinational food companies for a variety of recall- and food-import records dating as far back as 2000.

The letter suggests labs may have discarded test results indicating failures of Food and Drug Administration (FDA) standards at the encouragement of importing companies. “We’re gathering information from both the FDA and private industry about the labs almost being complicit in helping importers game the system,” said Representative Bart Stupak (Democrat-Michigan), chairman of the Oversight and Investigations subcommittee investigating the labs and food companies.  “Someone told us you pay for the result you want to get from the labs.”  The letter restates Stupak’s suspicion that testing on some samples was repeated until the food passed. (more…)

A federal agency has said truckers and bus drivers should steer clear of the smoking cessation drug Chantix.  The move comes after a recent study indicated that Chantix put users at a higher risk for traffic accidents.  It is just the latest problem linked to the Pfizer drug, which has also been linked to psychological side effects, including suicidal thoughts and behavior.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.   (more…)

Antipsychotics, even when taken for a very short time period, are likelier to land elderly people with dementia in the hospital.  In some cases, patients died.  Researchers stress the underlying problems, which require the need for these medications—behavioral problems such as aggression and agitation—pose real issues.  Alternatives are limited, the researchers added.  “A misreading of the findings would be we don’t need to do something for these nursing home residents,” said study author Dr. Gary J. Kennedy, head of geriatric psychiatry for Montefiore Medical Center in New York City.  The findings were published in the May 26 issue of the Archives of Internal Medicine.

Many experts feel behavioral interventions should be tried first and antipsychotics used as a last resort, “when the behavior or the psychiatric symptoms are really out of control and causing complete distress not only for the person suffering from Alzheimer’s, but for caregivers all around them,” said Maria Carrillo, director of medical and scientific affairs at the Alzheimer’s Association in Chicago. “It’s important to work these things out with the physician and, of course, do follow-up very closely together, so you can make sure these antipsychotics are having the effect you want and, if not, discontinue them immediately.” (more…)

More patients are complaining of squeaky hip replacement implants.  As recently as 2006, the American Association of Orthopedic Surgeons called the recently emerging hip squeaking phenomenon an “underreported medical trend that has stumped the medical community.”  “As a surgeon, hearing someone walk, hearing them squeak, it’s a little unsettling,” said Dr. Andy Star, chief of orthopedics at Abington Memorial Hospital. “We are a little anxious about it and we honestly don’t know what to tell the patients.”

Other than going through a second major surgery, there are virtually no options for dealing with the squeaking that doctors are reporting among some patients who received ceramic hip replacements.  Reports of noisy joints following hip replacements were very rare before 2003 when the federal Food and Drug Administration (FDA) approved the first ceramic-on-ceramic implant for total hip replacements. (more…)

Emerging research just this week indicates that men working as painters and decorators who are exposed to glycol ethers are more likely to have poor semen quality.  Scientists from the Universities of Sheffield and Manchester conducted the research.

Research findings, which have been published in the British medical journal Occupational Environmental Medicine, reveal that men who work with solvents such as glycol ether have a 2.5-fold increased risk of experiencing a low motile sperm count compared to men with low exposure.  Glycol ethers are widely used in many products including water-based paints, a product which is used by many painters and decorators.  Glycol ether is often used in dermatological products such as skin creams and is also used as a fixative for perfumes; an insect repellent; a topical antiseptic; a solvent for cellulose acetate, some dyes, inks, and resins; and in preservatives and pharmaceuticals. (more…)

Immediately following the Hurricane Katrina devastation, the Federal Emergency Management Agency (FEMA) ordered about $2.7 billion worth of trailers and mobile homes to house Katrina victims.  FEMA’s requirements were detailed in a mere 25 lines, with minimal details regarding occupant safety.  Today, industry and government experts say this is linked to a public health catastrophe involving 300,000 people, many children, who lived in FEMA homes and were—in many cases—exposed to high formaldehyde levels exceeding the Centers for Disease Control and Prevention’s (CDC) recommended 15-minute exposure limit for workers.  Fifteen minutes is the limit at which acute health symptoms begin to appear in sensitive individuals.

“I still can’t believe that we bought a billion dollars’ worth of product with a 25-line spec. There’s not much you can do in 25 lines to protect life safety,” said Joseph Hagerman, a Federation of American Scientists expert spearheading a $275 million effort, funded by the Department of Homeland Security, to develop new emergency housing. FEMA has also been criticized not responding sooner when it received reports of problems. (more…)