More Detail on Risk Urged for a Contraceptive Label
On December 8, 2011, the New York Times published an article noting the results of a recent U.S. Food and Drug Administration (F.D.A.) hearing on the popular birth control pills, Yaz and Yasmin, both manufactured by Bayer. The F.D.A.’s advisory committee discussed studies that provide conflicting evidence on the incidence of blood clotting events in […]
F.D.A. Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections
On August 30, 2011, the U.S. Food and Drug Administration (F.D.A.) issued a warning to health care professionals regarding use of repackaged Avastin (bevacizumab) in eye injection treatments. The F.D.A. cited 12 recent cases of serious eye infections in the Miami area after use of Avastin for treatment of eye diseases.
Avastin Injections Are Reported to Cause Blindness
On August 30, 2011, the New York Times published an article reporting that sixteen people in Tennessee and Florida suffered severe eye infections and blindness after receiving treatment with Avastin eye injections. Avastin is a low-cost drug used by some eye doctors to treat patients with the wet form of age-related macular degeneration, a condition […]
Five More Reports of Avastin Injections Causing Blindness
On September 1, 2011, the New York Times published an article reporting that five patients at the Los Angeles Veterans Affairs medical center were blinded after receiving Avastin eye injection treatment. Avastin is a cancer drug that is also used to treat the wet form of age-related macular degeneration. This drug costs approximately $50 per […]
Risk Reports Chill the Use of a Cheaper Eye Drug
On October 5, 2011, the New York Times published an article regarding recent incidents of vision loss in 21 patients across the country after use of Avastin injections for eye conditions. Avastin is a cancer drug prescribed off-label by eye doctors for the treatment of macular degeneration and other serious eye conditions.
Button batteries can be fatal to kids if ingested, experts warn
On November 22, 2011, the Chicago Tribune published an article concerning the dangers presented to children by button batteries. Button batteries, often made of lithium, pose a special threat to children who may ingest them. These coin-sized batteries are used in small electronic devices, such as musical greeting cards and remote controls. When ingested, a […]
F.D.A. Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast
On September 1, 2011, the Food and Drug Administration (F.D.A.) updated the Reclast drug label to include a new warning on the increased risk of kidney (renal) failure for patients taking the medication. This update comes after cases of acute renal failure were reported to the F.D.A. as a result of using Reclast.
Investigation Finds Recalls for Replacement Body Parts
On November 17, 2011, CBS 11 News broadcast a news segment regarding the 510(k) rule, a medical device approval process used by the F.D.A. to fast-track products into the market. The news segment focused on the 510(k) process used to approve the DePuy ASR XL hip system, which was recalled by DePuy Orthopaedics, Inc. in […]
DePuy ASR MDL Litigation Update
A DePuy ASR MDL status conference was held on Tuesday, November 22, 2011 before the Honorable David Katz, the judge overseeing the federal multidistrict litigation against DePuy Orthopaedics, Inc. and Johnson & Johnson regarding the recalled DePuy Orthopaedics ASR hip replacement devices.
F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug
On November 18, 2011, the New York Times published an article referencing the F.D.A.’s recent decision to revoke the drug Avastin as a treatment option for breast cancer patients. This decision came after a two-day hearing held in June of this year.