Friday, June 20, 2008

FDA Adds Black Box Warning on Antipsychotic Medications for Dementia Patients; Morphine Sulfate Tablets Recall

The FDA has added a black box warning to conventional antipsychotic medications, citing an increased risk of death with their use among dementia patients.
From WebMD:
In 2005, the FDA warned that clinical trial data strongly suggested that newer "atypical" antipsychotics increase the risk of death in dementia patients. The agency required these drugs to carry its strongest "black box" warning on their labels.

Now, based on observational studies, the FDA warns that older antipsychotics also seem to increase dementia patients' risk of death. These drugs, too, will carry a black box warning.

We also wanted to share a voluntary recall of morphine sulfate tablets:
Ethex Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by Ethex Corporation under an 'Ethex" label between April 16th and April 27th of 2008.

For any questions related to this action, please contact Ethex Customer Service (representatives are available Monday through Friday, 8 am to 5 pm CST): Telephone 1-800-321-1705.

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1 Comments:

Anonymous Anonymous said...

MAXIDEX WARNING

I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by LCON LABS.

Two days later I was BLIND

Use Google and enter EPOCRATES MAXIDEX to verify

August 7, 2008 3:35 PM  

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