Will Australia Follow U.S. FDA’s Lead in Requiring Painkiller Makers to Warn Buyers of Reactions Such as Skin Blistering? (VIDEOS)
The U.S. Food and Drug Administration required on Thursday the manufacturer of Tylenol and other popular painkillers to warn consumers of the risk of the medication's side effects, including skin blistering and sloughing off the body.
Dr Sharon Hertz, deputy director of FDA'S Division of Anesthesia, Analgesia and Addiction, said the warning does not intend to scare consumers or health professionals or to encourage them to use other medication for pain.
"However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious side effect, which are potentially fatal," Ms Hertz said in a statement.
The FDA has issued a similar warning in 2005 against non-steroidal anti-inflammatory drugs like Advil after Karen Bartlett, a New Hampshire resident, suffered in 2004 a near-fatal reaction to the generic drug sulindac. In late June, the Supreme Court, however, cleared the manufacturer of sulindac over Ms Bartlett's injuries such as full-body burns and blindness, in effect reversing a jury verdict that granted the woman $21 million damages.
With the new rules, FDA will require a black box warning on packaging for painkiller about the Stevens-Johnson Syndrome and the skin conditions that can occur without warning to people who may have previously used acetaminophen with no similar problems.
With the action of the U.S. FDA often taken as the lead by other nations, consumers in other western countries like Australia, New Zealand, Canada and Europe are monitoring if their own drug regulation agencies would follow the footstep on the painkiller warning.
Among the Australian states, it is South Australia which is active in planning a ban on all synthetic drugs that imitate the effect or are sold as alternative to illegal medication. The SA government placed a temporary ban in June on 19 such products after a teenager who used a substance known as NBOMe - a synthetic form of LSD that causes psychotic and hallucinogenic episodes - jumped to his death in Sydney.