FDA Drug Information Updates

The D.I.S.C.O. hosts discuss the agency’s first approval of pembrolizumab, a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

Released May 30, 2017.

FDA medical oncologists discuss the agency’s March 23, 2017 approval of avelumab for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma.

Released May 22, 2017

FDA medical oncologists discuss the agency’s March 2017 approval of niraparib for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

Released May 18, 2017

FDA medical oncologists discuss the agency’s accelerated approval of rucaparib for treatment of patients with deleterious BRCA mutation-associated advanced ovarian cancer who have been treated with two or more chemotherapies.

Released May 17, 2017

Based on new data from two large clinical trials, the FDA concluded that the type 2 diabetes medicine canagliflozin (brand names Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. The FDA is requiring new warnings, including their most prominent Boxed Warning, be added to the canagliflozin drug labels to describe this risk.

Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.

Report side effects involving canagliflozin and other medicines to the FDA MedWatch program at fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at fda.gov/DrugSafetyCommunications. If you have drug questions, contact the FDA at [email protected].

Released 5/16/2017

In the FDA's inaugural Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) episode, Dr. Richard Pazdur, director of the FDA Oncology Center of Excellence, talks with hosts Dr. Sanjeeve Bala and Dr. Abhilasha Nair about this new podcast series.

The Food and Drug Administration (FDA) is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. The FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

As a result, the FDA is requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond the 2013 restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. The FDA is now adding:

• FDA’s strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol …

FDA is recommending new safety measures to improve the safe use of long acting beta agonists (LABAs).

FDA is recommending new safety measures to improve the safe use of long acting beta agonists (LABAs).

The FDA has issued a public health advisory regarding serious medication errors that have arisen when consumers used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication,by mistake, when they had intended to use one of the traditional Maalox liquid antacid products.