Implantes de mama

Uma revisão da FDA indica possível associação com um tipo raro de câncer

[matéria publicada em DRUGS.COM (26/01/2011), originalmente mantida em Inglês]

ISSUE: FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

BACKGROUND: In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants. According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

RECOMMENDATION: In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.

The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.

Paracetamol

Produtos contendo combinações à base de acetaminofeno devem ser prescritos com dose máxima de 325 mg por comprimido ou cápsula

[parte de matéria publicada em DRUGS.COM (13/01/2011), originalmente mantida em Inglês]

FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.

Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action.

Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.

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.

Antibióticos

A nova regra de compra de antibióticos trará mais segurança à população?


Desde 28 de novembro, fica valendo a exigência da ANVISA (conforme publicada na RDC 44/10) para que haja retenção da receita para a compra de antibióticos na farmácia.

Apesar de saber da preocupação de entidades, como Abrafarma, Abcfarma e Conselho Federal de Farmácia, quanto ao péssimo acesso ao sistema de saúde e à necessidade das farmácias terem que adaptar seus sistemas de registros de vendas, considero esta uma atitude extremamente válida para a saúde atual e futura da população.

O uso indiscriminado de antibióticos, indicados muitas vezes no balcão de farmácias ou espontaneamente comprados como se fossem simples analgésicos ou anti-inflamatórios, pode aumentar o risco da criação de bactérias super-resistentes, uma vez que não seriam necessários em grande parte das vezes.

Em todo o caso, fica a polêmica: é melhor tratar menos, embora adequadamente, ou ampliar os tratamentos, continuando a fechar os olhos para a automedicação ou indicações por profissionais não autorizados?