Sedatives need amputation warning: FDA directive
POSTED September 17, 2009 - 12:54 | POSTED BY Jaspreet Kaur
Last edited by Harpreet Bhagrath on September 17, 2009 - 14:49
On Wednesday, the FDA said that manufacturers of generic promethazine will have to put a “black box” warning at the top of the detailed package insert stating that when used improperly, the drug can cause severe skin damage and, in extreme cases, even gangrene.
The FDA has given 30 days to companies so that they can provide satisfactory explanation on the package inserts. After this, the FDA can give directions for changes it thinks will be apt.
How to use promethazine
The FDA explained that promethazine needs to be injected deep into muscle. It should never be injected into an artery or beneath the skin.
Also, while administering the drug intravenously, care should be taken that it is done slowly and at a low concentration. Otherwise it can leak out of a vein causing serious harm to the surrounding tissue.
Promethazine is being sold since 1956 and is available in the United States. It is also available over the counter in the United Kingdom, Canada, Switzerland, Australia, among many other countries.
It is sold under various brand names like Phenergan, Promethegan, Romergan, Fargan, Farganesse, Prothiazine, Avomine, Atosil, Receptozine and Lergigan.
Promethazine under scanner
Since the past many years, the FDA has received reports which prove that the drug is associated with a number of gangrene cases that led to amputation.
The drug was earlier sold by Wyeth Pharmaceuticals Inc. under the brand name Phenergan. It has been at the centre of controversy when the U.S. Supreme Court passed a judgment this spring which said that consumers harmed by a drug approved by the FDA still have the right to take legal action against the manufacturer.
Wyeth had appealed against the case in the Supreme Court after a Vermont woman named Diana Levine, who was once a professional guitar and piano player, sued the company because her right arm had to be amputated after being injected with Phenergan.
In her lawsuit, Levine had claimed that the drug manufacturers had not properly informed of the risks associated with using Phenergan. The lawsuit had won her a whopping $6.7 million jury award.
