The US Food and Drug Administration (FDA) has added 8 drugs to its list of products to monitor because of possible signs of serious risks or new safety information. The drugs treat conditions that include cancer, epilepsy, hypertension, and malaria.
The agency spotted yellow flags for the 8 drugs in the FDA Adverse Event Reporting System (FAERS) database during April, May, and June 2012.
Deaths due to narcotic abuse typically occur by overdose, and consequent respiratory failure. New data demonstrates a novel cause of death associated with narcotic abuse. On October 12, 2012 the US Food and Drug Administration (FDA) warned that individuals who abuse the prescription pain medication oxymorphone hydrochloride extended-release tablets (Opana ER, Endo Pharmaceuticals) are at serious risk of developing thrombotic thrombocytopenic purpura (TTP), a blood disorder that can result in kidney failure and death.
According to the FDA, cases of TTP linked to Opana appear to occur only when the drug is injected intravenously.
The FDA notes that in TTP, blood clots form in small blood vessels throughout the body. The clots can limit or block blood flow to the body’s organs, such as the kidneys, brain, and heart.
Platelets help the blood to clot. In TTP, as platelets form blood clots, fewer of them are available to assist with clotting in other parts of the body. This can lead to bleeding under the skin and internal bleeding.
TTP can cause death or lead to other complications with permanent damage, such as kidney failure, brain damage, or stroke.
FDA Adds 8 Drugs to Watch List
The US Food and Drug Administration (FDA) has added 8 drugs to its list of products to monitor because of possible signs of serious risks or new safety information. The drugs treat conditions that include cancer, epilepsy, hypertension, and malaria.
The agency spotted yellow flags for the 8 drugs in the FDA Adverse Event Reporting System (FAERS) database during April, May, and June 2012.
Read more: FDA Targets 8 drugs that have potential adverses health effects
Read more: CT scans Linked to Leukemia and Brain Tumors
Bacteria has a proclivity for finding any medium that can support its growth. That includes the gel that is used by ultrasonographers to perform routine ultrasounds. Normally the skin acts as a decent barrier against microbials but not always. Klebsiella and Pseudmonal organisms have a tendency to find their way through the skin barriers and can cause superficial or deep skin infections. Sterile technique and good habits are necessary to prevent contamination of these biologic media. The following FDA information as reported in MedScape details the recently discovered contamination of ultrasound gel.
A recent study published in the CDC's Morbidity and Mortality weekly report, 2011; 60:1487 addresses the epidemic of overdoses associated with prescription narcotic medication. Physicians unwittingly prescribe too much opioid medications and often turn their patients into narcotic addicts. The abstract follows:
The US Food and Drug Administration issued a warning to healthcare professionals and the public underlining the appropriate storage, use, application and disposal of fentanyl patches, including Duragesic (Janssen Pharmaceutical Inc) and generic patches, to prevent life-threatening harm from accidental exposure to fentanyl, particularly by children. The toxicology of Fentanyl is such that there is a very narrow range of therapeutic safety for this drug. Accidental overdose has become increasingly common. Adverse drug effects have been noted with increasing frequency in both in- and outpatient settings.
Read more: FDA Issues Fentanyl Patch Warning
Opiates are dangerous substances that can cause overdose, death and disability, and lead to toxicology malpractice lawsuits. Most narcotics have a narrow range of therapeutic benefit. Outside this range, they become dangerous because they can cause CNS effects and respiratory depression. When physicians change a patient from one opiate to another, the risk of an adverse health effect increases. That is because the potency of each narcotic differs, and similar doses may confer different degrees of analgesia and side effects. Narcotics commonly cause adverse drug events. The following recent news release discusses a scientific paper that addresses the ramifications of changing narcotic drug regimens in more detail.
Yes folks, those pills that everyone is taking, the lipid-lowering statins, have now become toxicologically controversial. Efficacy is now in question, risk/benefit analyses are shifting, and cardiologists and toxicologists are re-evaluating value. I came across this interesting interview with the FDA's Amy Egan, MD, MPH who discusses the story behind statin label changes. In late February 2012, the FDA issued new labeling changes for the entire statin drug class. First, all statins must now carry a warming noting that there have been reports of increased blood sugar and hemoglobin A1c levels with statin use. Second, labels must now warm about interactions between statins and protease inhibitors for HIV and Hepatitis C patients, because the interaction of the two could cause myopathy and acute renal failure. Read the interview:
Read more: Statins: The Toxicology and Why Label Changes are Necessary
