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FDA News Briefs for Wednesday, March 7, 2018

March 7, 2018

These Food and Drug Administration (FDA) developments came in this week:


FDA Authorizes Direct-to-Consumer BRCA Test

The FDA has authorized the Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 selected variants (23andMe). It is the first direct-to-consumer test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The test only detects three out of more than 1,000 known BRCA mutations. More Information.


Safety Alert: Hospira Hydromorphone Injection

The FDA announced a voluntary recall of 3 lots of hydromorphone injection, 10 mg/mL, 1 mL in 2 mL single dose vials. Hospira initiated the recall due to the potential that units from the affected lots may be empty or cracked at the bottom of the glass vial. Cracked vials may compromise the sterility of the product. More Information.


Safety Alert: Sagent Pharmaceuticals Methylprednisolone for Injection

The FDA announced the voluntary nationwide recall of 10 lots of methylprednisolone sodium succinate for injection, usp, 40 mg, 125 mg, and 1 g. The affected products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall due to the discovery of high out-of-specification impurity results detected during routine quality testing of stability samples for two lots. An elevated impurity has the potential to decrease effectiveness of the product in patients. More Information.