FDA Recalls Generic version of drug of Powerful Sedative
This drug is reportedly linked to Michael Jackson’s Death
Two tainted lots of a generic version of a drug reportedly taken by Michael Jackson have been recalled by the drug maker. Teva Pharmaceuticals has voluntarily recalled Propofol, the generic version of Diprovan, which is a powerful anesthetic and sedative.
However, no link has been established between the drug and the singer’s death. Jackson died June 25 of cardiac arrest. The CDC is not involved in the investigation into Jackson’s death.
The CDC issued a health advisory Monday, stating two lots of a generic version of the drug had tested positive for endotoxin, a contaminant.
There are 40 reported events of patients developing high fevers and muscle aches after being injected with the drug. All of the people who had taken propofol recovered; only one was hospitalized and that patient was quickly discharged.
At high doses, endotoxin can lower blood pressure and cause much more serious reactions. A decrease in blood pressure can cause problems with the heart, said Dr. Arjun Srinivasan, the chief investigator on the recall for the Centers for Disease Control and Prevention.
Teva Pharmaceuticals is working with the FDA to determine how the contamination occurred and is voluntarily recalling the affected lots.
According to Teva, about 57,000 100 ml vials were recalled. With regard to the Jackson investigation, spokeswoman Denise Bradley said, “I can say the DEA did contact us about a specific lot number, and that lot number is not from the two we are recalling.”
The affected lots are 31305429B and 31305430B. Healthcare professionals are advised to immediately stop using these lots of propofol.
The Associated Press and the Los Angeles Times, citing unidentified sources, have reported that police found the drug Diprivan, a brand-name version of propofol, among Jackson’s medicines.
The FDA requests reports of adverse events with propofol are made to MedWatch. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.
The FDA can be contacted via:
- Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch,
5600 Fishers Lane, Rockville, MD20852-9787
- Fax: 800-FDA-0178
- Phone: 800-FDA-1088