FDA Targets Unapproved Quinine Drugs
U.S. companies that make unapproved prescription drugs that contain quinine have been given 60 days to stop producing the products, the U.S. Food and Drug Administration said Tuesday.
The unapproved drugs are most often prescribed to prevent or treat leg cramps but there are serious safety concerns, including patient deaths, associated with drugs that contain quinine, the FDA said.
Quinine is approved for the treatment of malaria. Because malaria is life-threatening, the risks associated with quinine are justified, the FDA said. There is one FDA-approved quinine drug to treat certain types of malaria without complications. That drug is not affected by the FDA order announced Tuesday.
The label on the approved drug includes warnings about the potential serious side effects of quinine and other important safety information. Quinine drugs can cause cardiac arrhythmias, severe hypersensitivity reactions, and thrombocytopenia, a decrease in blood platelets that can cause hemorrhage or clotting problems.
In addition, there can be serious interactions between quinine drugs and other drugs.
Since 1969, the FDA has received 665 reports of serious adverse events, including 93 deaths, associated with quinine drugs.
-----
Moderate Drinking May Lengthen Life
A drink or two a day may help extend your life, suggests an Italian study in the journal Archives of Internal Medicine.
A team at the Research Laboratories of the Catholic University of Campobasso analyzed data on more than a million people and concluded that men who drank up to four small bottles of beer or four small glasses of win a day reduced their risk of dying by almost 20 percent. The same degree of benefit was noted in women who drank two 100 milliliter glasses of wine or two 200 milliliter bottles of beer a day, reported the Daily Express in the U.K. One hundred milliliters is equal to just under 4 ounces.
It was already known that moderate consumption of red wine lowered the risk of heart disease. But this study suggests that moderate drinking reduces the risk of death from all causes.
It's believed that wine, beer and cider may help reduce levels of bad cholesterol and boost levels of good cholesterol. The scientists who conducted this study said that certain compounds found in wine and beer can also help cells repair DNA damage, the Daily Express reported.
"Alcohol contains substances that can protect the body from diseases such as cancer, diabetes and heart disease and this study underlines its beneficial effects," said Professor Giovanni de Gaetano, director of the Research Laboratories. "But the key is not to drink too much as excess immediately increases the risk of an early death."
He noted that other studies have found that spirits don't offer the same protective effects as beer and wine.
-----
Gene Mutation Linked to Family's High Risk for Pancreatic Cancer
U.S. researchers have identified a genetic mutation that may be linked to inherited pancreatic cancer in a Washington state family that's stalked by the disease.
Members of the Chappell family inherit a 50 percent risk of pancreatic cancer. If further research confirms that the genetic mutation is indeed responsible, then the mutation could be used to identify which family members are at risk for the disease, USA Today reported.
Family members without the mutation could have some peace of mind while those with the mutation could be screened in an effort to catch the disease at the early stages, said study senior author Dr. Teri Brentnall of the University of Washington in Seattle.
The study was published online in the journal PLoS Medicine.
While the Chappell family's high risk level may be unique, research into the genetic factors that influence their high rate of pancreatic cancer may help scientists learn more about this and other forms of cancer, USA Today reported.
-----
FDA Approves Drug to Treat Relapsed Lymphoma
The cancer drug Velcade (bortezomib) has been approved by the U.S. Food and Drug Administration for treatment of patients with relapsed mantel cell lymphoma (MCL).
MCL is an aggressive type of non-Hodgkin's lymphoma. The approval offers a new treatment option for these patients. Currently, there are no generally accepted treatment approaches and few options. Velcade is the first drug to receive FDA approval for treatment of patients with relapsed MCL.
A study found that 31 percent of MCL patients who'd received one or two prior therapies responded to Velcade, including eight percent who achieved a complete response that lasted a median of 13. 5 months.
The most common side effects included gastrointestinal problems, fatigue, and numbness and tingling in the hands and feet.
There are about 10,000 MCL patients in the United States. The average life expectancy for patients with relapsed MCL is one to two years. About 20 percent of patients with relapsed MCL survive at least five years.
-----
FDA Would Widen Patient Access to Experimental Drugs
New rules that would provide easier access to experimental drugs for seriously ill patients who have no other treatment options are being proposed by the U.S. Food and Drug Administration.
The proposed regulatory changes would also clarify the circumstances and costs for which drug makers could charge for an experimental drug.
"FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients," Dr. Janet Woodcock, FDA's deputy commissioner for operations, said in a prepared statement.
"By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for health-care practitioners in obtaining them," Woodcock said.
In order for an experimental drug to be approved for patients, the FDA would have to be satisfied that the potential benefits of the drug outweigh the risks.
The proposed changes, released Monday, are subject to comment for 90 days.
No comments:
Post a Comment