Here are 3 drug/patient safety related update for your reference:
• FDA Warns of Botulinum Toxin Type A & Type B
• Antiepileptic & Risk of Suicidal Thoughts
• New Labeling Required for OTC Pain and Fever Medicines

• FDA Warns of Botulinum Toxin Type A & Type B
 US FDA recently notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required to add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.
FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy (REMS), including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

• Antiepileptic & Risk of Suicidal Thoughts
On, 05/05/2009 US FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. This class of antiepilectic drugs (11 drugs as listed below) is associated with increased suicidality risk based on a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the 11 drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

1. Carbamazepine
2. Felbamate
3. Gabapentin
4. Lamotrigine
5. Levetiracetam
6. Oxcarbazepine
7. Pregabalin
8. Tiagabine
9. Topiramate
10. Valproate
11. Zonisamide

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic

• New Labeling Required for OTC Pain and Fever Medicines
In the US, makers of OTC analgesics & antipyretic must revise their labeling to include warnings about potential safety risks associated with these popular drugs. These risks include internal bleeding and liver damage.

Final Rule
In a final rule issued on April 28, 2009, the US FDA directed that labeling be revised for paracetamol & NSAIDs. These are two classes of commonly used drugs that are effective in reducing fevers and relieving minor aches and pain such as headaches and muscle aches. NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen.

The final rule applies to all OTC durg  either as single entity or combination products. Under the final rule, manufacturers must include warnings on label about the risk of stomach bleeding for NSAIDs and the risk of severe liver damage for paracetamol.

Overdoses and Other Risks
Safety data reported in medical literature indicate that people sometimes take more paracetamol than the labeling recommends. Others unknowingly take multiple products containing paracetamol at the same time.
Exceeding the recommended dosage of paracetamol may increase the risk of severe liver damage. Alcohol use can also increase the risk of liver damage with paracetamol.
The risk of stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.
An FDA Advisory Committee meeting will be held on June 29 and 30, 2009, to discuss further steps the agency could take to reduce the risk of liver damage associated with paracetamol overdoses.

For More Information
FDA Press Release
www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html

A Guide to Safe Use of Pain Medicine
www.fda.gov/consumer/updates/painmeds022309.html

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