Affymax and Takeda Institute a Recall of OMONTYS

Posted by Buck Daniel

February 25, 2013 – On February 23rd, Affymax and Takeda instituted a recall of OMONTYS following serious adverse reactions, including life threatening and fatal events. Omontys is used to treat anemia associated with chronic kidney disease for patients on dialysis. Anemia, in which the body is unable to produce enough red blood cells to deliver oxygen to the body’s organs, is often found in kidney dialysis patients. The condition causes fatigue and sometimes heart attacks.

Omontys was produced as an alternative to Epogen, which has been a staple of kidney-dialysis treatment since 1989. However, despite having knowledge that the safety endpoint of cardiovascular events and death was worse for Omontys than for its alternative Affymax kept Omontys on the market. It was further proven, through two randomized controlled trials published in 2013, that Omontys was no more effective than its alternative despite having far greater risks.

About five patients were reported to have died after receiving Omontys, according to the figures provided by Affymax, and around 17 had severe allergic reactions requiring immediate medical help and, in some cases, hospitalization. The reactions could occur within 30 minutes of the first dose.

Hip Implants a Bit More Likely to Fail in Women

From ABC13 KTRK News

February 19, 2013 – Hip replacements are slightly more likely to fail in women than in men, according to one of the largest studies of its kind in U.S. patients. The risk of the implants failing is low, but women were 29 percent more likely than men to need a repeat surgery within the first three years.

The message for women considering hip replacement surgery remains unclear. It’s not known which models of hip implants perform best in women, even though women make up the majority of the more than 400,000 Americans who have full or partial hip replacements each year to ease the pain and loss of mobility caused by arthritis or injuries.

“This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences,” said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families. “Research in this area could save billions of dollars” and prevent patients from experiencing the pain and inconvenience of surgeries to fix hip implants that go wrong.

Researchers looked at more than 35,000 surgeries at 46 hospitals in the Kaiser Permanente health system. The research, published Monday in JAMA Internal Medicine, was funded by the U.S. Food and Drug Administration.

After an average of three years, 2.3 percent of the women and 1.9 percent of the men had undergone revision surgery to fix a problem with the original hip replacement. Problems included instability, infection, broken bones and loosening.

“There is an increased risk of failure in women compared to men,” said lead author Maria Inacio, an epidemiologist at Southern California Permanente Medical Group in San Diego. “This is still a very small number of failures.”

Women tend to have smaller joints and bones than men, and so they tend to need smaller artificial hips. Devices with smaller femoral heads — the ball-shaped part of the ball-and-socket joint in an artificial hip — are more likely to dislocate and require a surgical repair.

That explained some, but not all, of the difference between women and men in the study. It’s not clear what else may have contributed to the gap. Co-author Dr. Monti Khatod, an orthopedic surgeon in Los Angeles, speculated that one factor may be a greater loss of bone density in women.

The failure of metal-on-metal hips was almost twice as high for women than in men. The once-popular models were promoted by manufacturers as being more durable than standard plastic or ceramic joints, but several high-profile recalls have led to a decrease in their use in recent years.

“Don’t be fooled by hype about a new hip product,” said Zuckerman, who wrote an accompanying commentary in the medical journal. “I would not choose the latest, greatest hip implant if I were a woman patient. … At least if it’s been for sale for a few years, there’s more evidence for how well it’s working.”

MedWatch – Zithromax (azithromycin): FDA Releases Statement on Risk of Cardiovascular Death

By Amber Stanford

May 26, 2012 – The FDA has recently recognized a new study released in the issue May 17, 2012 of the New England Journal of Medicine that reports a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug at all. The FDA intends to further review this research any findings.