Bevacizumabe

FDA inicia o processo para retirada da indicação do Avastin (bevacizumabe) para o tratamento do câncer de mama

[parte de matéria publicada em DRUGS.COM (16/12/2010), originalmente mantida em Inglês]

FDA notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

BACKGROUND: FDA is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

RECOMMENDATION: Oncologists currently treating patients with Avastin for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

Patients currently receiving Avastin for breast cancer should speak with their oncologists about whether to continue their treatment or explore other treatment options.

Propoxifeno

Propoxifeno proibido pela FDA devido ao risco de toxicidade cardíaca

[parte de matéria publicada em DRUGS.COM (19/11/2010), originalmente mantida em Inglês]

ISSUE: FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene, an opioid pain reliever used to treat mild to moderate pain, from the U.S. market at the request of the FDA, due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. FDA requested that the generic manufacturers of propoxyphene-containing products remove their products as well.

BACKGROUND: FDA’s recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart (see Data Summary in Drug Safety Communication). The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms.



OTCs

Instruções confusas em embalagens de muitos medicamentos para crianças isentos de prescrição


[parte de matéria publicada em DRUGS.COM, em 30/11/2010, originalmente mantida em Inglês]

The admonishment to parents to carefully follow the directions on the labels of over-the-counter kids' medicines may be futile, new research suggests. The study found that most of the popular cough-and-cold, pain-relieving, allergy and stomach drugs just don't explain dosing very well to begin with. Nor is there much consistency in product labeling.

"Almost all the products had inconsistencies," said Dr. H. Shonna Yin, lead author of an early-release study that will be published in the Dec. 15 print issue of the Journal of the American Medical Association.

"This is a real issue," added Dr. G. Randall Bond, medical director of the Cincinnati Drug and Poison Information Center at Cincinnati Children's Hospital. But he also pointed out that while "a large number of emergency visits are related to [over-the-counter medications], very few of those are related to misdosing. Most of the time it's kids who got into the medicine. That's the real driver."

The study comes almost exactly a year after the U.S. Food and Drug Administration (FDA) issued voluntary guidelines recommending that manufacturers of common over-the-counter medications be more consistent in their dosing directions and include measuring devices with the products, among other suggestions. The Consumer Healthcare Products Association, which represents these manufacturers, also issued voluntary guidelines.