Sleeping Aid Recall

Potentially habit-forming herbal sleep aid recalled

Health Canada issued an advisory Friday warning consumers against taking an herbal sleep aid because it could be habit-forming.

The federal agency says Sleepees contains the drug estazolam, which is not declared on its label. The supplement has not been authorized for sale in Canada.

The distributor, Vancouver-based Our World Network Inc., has stopped selling the herbal sleep aid and is recalling the following Sleepees product lots: B39054006, B39069004, B39035001, B38883003, B38893003, OWN 961, OWN-042606, OWN 980, OWN 913.

Estazolam, which should only be taken when prescribed by a health-care practitioner, can be potentially addictive when taken for as little as a few months.

"Consumers who may still have this product in their homes are advised to consult with a health-care professional before they stop taking the capsules, because of the risk of withdrawal symptoms," Health Canada said in a release.

Side-effects include depression, hallucinations

Side-effects linked with the use of estazolam may include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

No adverse reactions associated with the use of Sleepees have been reported in Canada.

Consumers should return the product to the place of purchase. For more information, people can call Health Canada's public enquiries line at at (613) 957-2991, or toll-free at 1-866-225-0709.

Source: CBC.ca

Drug Side Effects Report Cards - FDA

U.S. proposes 'report cards' for drugs

Last Updated: Tuesday, January 30, 2007 | 7:03 PM ET

Drug "report cards" may list any unexpected side-effects that become known within 18 months of a drug's approval, the U.S. Food and Drug Administration said Tuesday in response to criticism of the agency's drug safety oversight.

In September 2006, a panel of experts at the U.S. Institute of Medicine said the FDA needed to boost its staff, funding and power to track the safety of not only new medications, but also drugs already on the market.

The panel met after Merck & Co. pulled its anti-inflammatory drug Vioxx from the market in 2004, five years after it was approved. Long-term use of the drug was linked to an increased risk of heart attack and stroke.

The institute's report concluded that FDA officials downplayed concerns raised by safety reviewers after drugs were approved. The report also suggested the FDA did a poor job of managing scientific disagreements among staff.

In its response on Tuesday, the FDA said it was "making specific organizational and management changes to increase communications among FDA review staff and safety staff."

The response is not the final word, FDA Commissioner Dr. Andrew von Eschenbach said.

"It will be a continuous process of improvement. The initiatives we are announcing today are not the full story, nor are they the final chapter in that story," von Eschenbach told reporters in Washington.

The FDA's response includes plans to:

• Upgrade its electronic database for tracking potential side-effects.
• Create a new advisory panel on risk communication.
• Publish regular newsletters summarizing safety reviews of older drugs, including any emerging issues that do not include information the agency considers confidential.

The response came days before U.S. senators are to introduce legislation for drug safety changes.

Source: CBC.ca

In the Weeds

Source: TIME A to Z Health Guide