The Food and Drug Administration is requiring stronger safety warnings for a popular treatment to prevent pregnant women from prematurely giving birth.
Women should not be given injections of the drug terbutaline for more than three days "because of the potential for serious maternal heart problems and death," the FDA said Thursday. It is now requiring a boxed warning â€” the FDA's most serious type of warning â€” be added to the drug's label.
The FDA also warned doctors against prescribing a pill form of the drug for "any treatment of preterm labor" because it has not been shown to be effective and carries similar risks.
The FDA has approved terbutaline only to treat specific respiratory conditions, but doctors have widely prescribed the drug as a treatment for preterm labor. Once a drug has been approved by the FDA, doctors can prescribe the drug for any use they deem appropriate.
Many women receive it continuously for weeks through a terbutaline pump. Its use is strongly supported by some advocates for women carrying twins and triplets, who are at higher risk of giving birth prematurely.
"It would be alarming to me to see it become unavailable," said Janet Bleyl, president and founder of the Triplet Connection, a national support group for parents of multiples. "It has made a life-or-death difference for many, many of our families."
Depuy Reimbursement of Costs and Revision Surgery
Depuy Communicating with Doctors
Depuy ASR Reimbursement Process
On August 26, 2010, Johnson & Johnson announced their eleventh recall since September 2009. This recall stems from DePuy Orthopaedics Inc., which is a subsidiary of Johnson & Johnson..
DePuy Orthopaedics Inc., announced that it would be recalling its ASR Hip Resurfacing System and its ASR XL Acetabular hip-replacement system. According to the company, the recall took place because of new data from the National Joint Registry (NJR) of England and Wales which shows that within five years, one in eight patients needed a revision surgery, with the risk being highest amongst women. This translates to a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System.
Besides this device, Johnson & Johnson has recalled many over-the-counter drugs such as Childrenâ€™s Tylenol, Junior Strength Motrin, Childrenâ€™s Benadryl, Zyrtec Eye Drops, and Rolaids soft chews.
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