quinta-feira, 3 de fevereiro de 2011

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.

quinta-feira, 20 de janeiro de 2011

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.