FDA Commissioner Confirmed
On July 18, 2005, Lester M. Crawford D.V.M., Ph.D. was confirmed by the
Senate as Commissioner of the FDA. Dr. Crawford has served as the Acting
Commissioner for the past year. Previously, he served as Deputy Commissioner
of the FDA and as Director of the Center for Food and Nutrition Policy at
Georgetown University and Virginia Tech. Dr. Crawford has demonstrated a
continued commitment to working with OWH. In one of his first acts in his
new position, Dr. Crawford announced the establishment of a new women's health
award at the FDA. OWH congratulates Dr. Crawford on his confirmation, and
we look forward to future successful collaborations.
OWH -- BlueCross/ BlueShield Partnership
OWH has partnered with BlueCross/ BlueShield (BC/BS) to bring the latest
health information to women and their families. OWH supplied each of the
20 BC/BS regional directors with a CD containing our most popular fact sheets,
ranging from mammography to diabetes. Each region will print and distribute
copies to members across the country.
Recalls / Safety Alerts / Approvals
The Food and Drug Administration (FDA) issued a public health advisory on
Mifepristone (trade name Mifeprex, also known as RU-486). The advisory noted
that from September 2003 to June 2005 four women in California died from
sepsis (blood infection) following medical abortion with mifepristone and
misoprostol. The bacteria that caused the sepsis in two of the cases have
been identified as Clostridium sordelli. No causal relationship between these
events and the use of Mifeprex and misoprostol has been established. Sepsis
is a known risk associated with any type of abortion. Clostridium sordelli
is a bacterium that in very rare cases produces toxins that are rapidly fatal.
The patients in whom Clostridium sordelli was identified had no fever but
had a rapid pulse, low blood pressure, and very high red and white blood
cell counts. They also had symptoms that included weakness, nausea, vomiting
or diarrhea with or without abdominal pain.
The public health advisory called for advising patients to contact their
health care professional immediately if they develop any of these symptoms
with or without fever. A dear health care provider letter was written and
sent by the manufacturer, Danco Laboratories. Label changes also were made
to alert physicians and patients to the possibility of this rare infection.
July 29, 2005: Recall of Counterfeit "Lipitor" Sold in the United
Kingdom
The Food and Drug Administration (FDA) alerted U.S. residents to the recent
recall of a batch of counterfeit "Lipitor" (atorvastatin) sold
in the United Kingdom (U.K.). The medicine is used to treat high cholesterol.
The counterfeit Lipitor 20mg tablets were recalled in the U.K. on July 28,
2005. The affected product is sold in packages of 28 tablets. The
drug packages are marked with batch number 004405K1 and an expiration date
of 11 2007.
Complications from Metallic Tracheal Stents in Patients with Benign Airway
Disorders
The Food and Drug Administration (FDA) alerted health care practitioners
of serious complications associated with the use of metallic tracheal stents
in patients with benign airway disorders. The notification includes all covered
and uncovered metallic tracheal stents. This notification focuses on patients
with benign airway disorders because use of metallic stents in this patient
population may preclude them from receiving future alternative therapies
(such as tracheal surgical procedures or placement of silicone stents) after
a metallic stent is removed. This patient population has a greater risk of
serious complications than those with malignant disorders since the metallic
tracheal stent is left in place longer.
July 28, 2005: Approvable Letter to Mentor Corporation
The Food and Drug Administration (FDA) issued an approvable letter to Mentor
Corporation for their application for silicone gel-filled breast implants.
Federal law and regulations prohibit the government from discussing the specific
contents of the letter. However, an approvable letter is one of several intermediate
steps in the FDA review process of new products. Previously at their April
2005 meeting, the General and Plastic Surgery Devices Advisory Committee
voted 7-2 that Mentor's application was Ïapprovable with conditions.Ó This
letter does not mean that the device is approved for marketing in the United
States at this time.
View all recalls and alerts for the past
60 days. |
