Here are 3 safety news  related to health products for your information & updates.

● HSA Alerts on Adulterated “Power 1 Walnut”

The HSA warns members of the public not to consume an illegal product labelled as“Power 1 Walnut 动力一号核桃素片” found to contain two potent western medicinal ingredients,namely glibenclamide and sildenafil.   Glibenclamide and sildenafil  are prescription only medicines  which should only be taken under strict medical supervision. The photograph of the illegal product is shown.
Sildenafil and glibenclamide are substances controlled under the Poisons Act. It is an offence for an unlicensed person to import, sell or possess for sale any product containing these substances. Anyone found guilty of an offence under the Poisons Act is liable to a fine of up to $10,000 and/or imprisonment for a term of up to two years. For more information, please visit:  http://www.hsa.gov.sg/publish/hsaportal/en/news_events/press_releases/2008.html

• New Safety Warnings for Pfizer’s Anti-smoking Drug - Varenicline
US FDA has again issued a Public Health Advisory on Feb. 1, 2008, to alert health care providers, patients, and caregivers to new safety warnings concerning varenicline (Chantix, or Champix in Singapore) is a prescription medication used to help people stop smoking. 

Vrenicline was approved by FDA in May 2006. In November 2007, FDA issued an Early Communication to tell the public and health care providers that the agency was evaluating adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal thoughts, and attempted and completed suicide.

As FDA continues its review of the adverse event reports, it appears increasingly likely that there may be an association between Chantix and serious mood and behavior symptoms.

FDA has requested that Pfizer, the manufacturer of Chantix, give the safety information a more prominent position on the drug's prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” says Bob Rappaport, M.D., Director of FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. "Patients should talk with their doctors about this new information and whether Chantix is the right drug for them."

Tips for Consumers
Tell your health care provider about any history of psychiatric illness before you start taking Chantix.
Immediately tell a doctor if you or someone you care for has any changes in mood and behavior while being treated with Chantix. In most cases, mood and behavior changes developed during treatment, but some people developed symptoms after they stopped taking Chantix.
Be aware that vivid, unusual, or strange dreams may occur while taking Chantix.
Chantix may affect your ability to drive or operate machinery.
For More Information http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html

Date Posted: February 5, 2008

• Serious Health Risks with Antiepileptic Drugs
US FDA issued new information on Jan. 31, 2008, to alert health care professionals about an increased risk of suicidal thoughts and behaviours in patients who take medications called antiepileptics. Such drugs treat epilepsy, bipolar disorder, migraine headaches, and other conditions.

FDA studied suicidality reports from 11 antiepileptic drug studies and found that patients taking antiepileptics have about twice the risk of suicidal thoughts and behaviors, compared with patients receiving an inactive substance (placebo). This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidality than in the placebo groups.

FDA recommends that:
Patients currently taking antiepileptic medicines not make any changes without first talking to their health care providers.
Health care providers notify patients, their families, and caregivers of the potential for an increase in the risk of suicidality, so that patients can be closely observed for notable behavior changes.
Although only the following drugs were part of the analysis, FDA expects that all medications in the antiepileptic class share the increased risk of suicidality:

• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Levetiracetam (marketed as Keppra)
• Oxcarbazepine (marketed as Trileptal)
• Pregabalin (marketed as Lyrica)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
• Zonisamide (marketed as Zonegran)

The agency will work with manufacturers of marketed antiepileptic drugs to include this new information in the labeling of these products. FDA anticipates that labeling changes will be applied broadly to the entire class of drugs.

An upcoming FDA advisory committee meeting will address these data.

For More Information http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html

FDA Information for Healthcare Professionals: Suicidality and Antiepileptic Drugs
www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm

Date Posted: February 5, 2008

**********