Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Anemia Drug Recalled Due to Reactions Among Dialysis Patients
A voluntary recall has been issued by the makers of the anemia drug Omontys because of reports that the treatment can cause serious, and sometimes fatal, allergic reactions in some kidney dialysis patients.
Takeda Pharmaceuticals Co., of Osaka, Japan, and Palo Alto, Calif.-based Affymax Inc. said in a joint statement on their websites Sunday that all lots of the drug have been recalled and doctors should stop prescribing Omontys (peginesatide). The medication is used to treat anemia in people with chronic kidney disease.
Among the first 25,000 patients who received a first injection of Omontys, .02 percent suffered fatal allergic reactions that included anaphylaxis shock, the companies said in the statement. The reaction typically occurred within 30 minutes of the first injection of Omontys.
In a statement released Sunday, the FDA said it has received 19 reports of anaphylaxis, three resulting in death, from dialysis centers in the United States.
Some of the patients were resuscitated by doctors, the agency added.
“Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys,” said Howard Sklamberg, director, Office of Compliance, FDA’s Center for Drug Evaluation and Research. “Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”
Overall, about .2 percent of dialysis patients suffered some level of allergic reaction, and a third of those were serious enough to require medical intervention and sometimes hospitalization, the companies said in their joint statement.
“Our company is working with the FDA and Affymax, and decided to voluntarily recall Omontys to put patients’ safety first,” said Kazumi Kobayashi, a spokesman for Takeda, Bloomberg News reported.
The U.S. Food and Drug Administration approved the treatment last March, according to Bloomberg.
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New Breast Cancer Drug Approved by FDA
A new drug for late-stage breast cancer has been approved by the U.S. Food and Drug Administration.
Genentech’s Kadcyla (ado-trastuzumab emtansine) is for use in patients with HER2-positive, late-stage breast cancer who were previously treated with another anti-HER2 drug called Herceptin (trastuzmab) and a class of chemotherapy drugs called taxanes, which are commonly used to treat breast cancer.
“Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA news relase.
“Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein,” he explained.
The FDA’s approval of the drug was based on a study of 991 patients. Kadcyla carries a boxed warning that it can cause liver and heart problems and even death. It can also cause life-threatening birth defects, the agency said.
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4 Indicted in Peanut Butter Salmonella Outbreak
Four former employees of a Virginia-based peanut company linked to a 2009 salmonella outbreak in the United States have been indicted by a federal grand jury.
The outbreak — traced to a peanut processing plant in Georgia — killed nine people and sickened hundreds and led to one of the largest recalls in the nation’s history.
The 76-count indictment charges the former employees of Peanut Corp. of America with conspiracy, wire fraud, obstruction of justice and other offenses related to contaminated or misbranded food, the Associated Press reported.
Those facing the charges are company owner Stewart Parnell, his brother and company vice president Michael Parnell, Georgia plant manager Samuel Lightsey and Georgia plant quality assurance manager Mary Wilkerson.
FDA inspectors found numerous problems at the plant in Blakely, Ga., including mold and roaches. The company went bankrupt after the recall, the AP reported.
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Medical Groups Warn About Unnecessary Tests and Treatments
Dozens of types of tests and treatments are too often recommended by doctors when patients don’t need them, according to a warning issued Thursday by a coalition of leading medical groups in the United States.
This unnecessary care wastes time and money and sometimes causes harm to patients, according to the organizations that represent more than 350,000 doctors, the Associated Press reported.
The Choosing Wisely Coalition said patients need to ask their doctors, “Do I really need that?” The coalition was formed by the American Board of Internal Medicine Foundation.
Too many people “think that more is better, that more treatment, more testing somehow results in better health care,” Dr. Glen Stream, former president of the American Academy of Family Physicians, told the AP. “That really is not true.”
The academy contributed to this year’s list of 90 examples of potentially needless care, which adds to 45 examples included on last year’s list. Among the newly-added warnings:
- Don’t screen for a clogged neck artery in healthy people with no stroke signs. It could lead to risky surgery for a blockage that would cause no harm.
- Don’t try feeding tubes in people with advanced dementia. Helping them eat is a better approach.
- Don’t routinely give heartburn medicine to infants with reflux. This treatment hasn’t been proven effective in babies and could cause side effects.
- Don’t prescribe opioid painkillers for migraines except as a last resort. Opioids can carry the risk of addiction and can actually worsen migraines. Instead, use more migraine-specific drugs.
- Don’t induce labor if a pregnant woman misses her due date and both mother and baby are doing fine.
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New Silicone-Gel Breast Implant Approved by FDA
A new silicone-gel breast implant for women 22 years and older has been approved by the U.S. Food and Drug Administration.
The agency said that Allergan’s Natrelle 410 implant contains silicone gel that is firmer than the company’s older Natrelle models, the Associated Press reported.
The approval was based on data from 941 women collected over seven years. Allergan’s studies did not compare the safety of the new implant with that of the older models.
“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Dr. Jeffrey Shuren, the FDA’s medical device director, the AP reported. “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.”
Silicone-gel implants were banned by the FDA in 1992 due to fears they could cause illnesses such as cancer and lupus. But the ban was lifted in 2006 after research ruled out most of the health concerns.