Friday, June 5, 2009

Propylthiouracil poses risk of serious liver injury

Propylthiouracil (PTU) treats hyperthyroidism (including Graves disease) by decreasing the amount of thyroid hormone produced by the thyroid gland. Its notable side effects include a risk of agranulocytosis. Agranulocytosis is a rare, drug-induced blood disorder that is characterized by a severe reduction in the number of white blood cells in the circulating blood.

Propylthiouracil is only available in the United States as a generic medication. Some manufacturers include Actavis Elizabeth, LLC of New Jersey and West-Ward Pharmaceutical Corp, also, of New Jersey.

Recently on June 3, 2009, the FDA alerted healthcare professionals of the seriousness of hepatic reactions related to PTU. It poses a risk of serious liver injury, including liver failure and death in adult and pediatric patients.

Reports to FDA’s Adverse Event Reporting System suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole. Metimazole is another treatment option for thyroid disorders. FDA has identified 32 cases (22 adult and 10 pediatric) of serious liver injury associated with PTU use. Although both PTU and Metimazole are treatments of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease.

Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months of treatment.

PTU should not be used in pediatric patients as a last resort. The FDA suggests that PTU only be used in pediatric patients who are allergic to or intolerant of Metimazole, and there are no other treatment options available.

West-Ward’s label from September 2007 does warn of agranulocytosis and of severe hepatic reactions. It is generally perceived the treatment of hyperthyroidism and not the disease itself causes these serious side effects.

Reports of adverse events associated with Propylthiouracil, including liver failure, should be reported to the FDA.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm

Labels: children, death, FDA, hepatic, Liver, PTU

posted by Jessica at 10:32 AM

Wednesday, May 27, 2009

Reports of Hepatotoxicity for Orlistat, the Active Ingredient for Xenical and Alli

On April 16, 2009, the Drug Safety Oversight Board briefly discussed orlistat and the potential risk of hepatotoxicity.

Orlistat is the active ingredient in anti-obesity drugs such as the prescription drug Xenical and the over-the-counter drug Alli.

Xenical is manufactured by Roche, which is headquartered in Nutley, N.J. Alli is manufactured GlaxoSmithKline, which is headquartered in England.

Sue Sutter of Scrip News in her May 21, 2009 article "US FDA examining reports of liver damage with orlistat" gives more details on the relationship between Orlistat and hepatotoxicity.

"Orlistat was discussed in the context of both non-prescription and prescription versions and the potential risk of hepatotoxicity based on several post marketing reports," the FDA told Scrip.

The agency said it was still reviewing the case reports to determine the extent of orlistat's contribution, if any, to the development of liver damage. The FDA declined to provide the number of post marketing reports it has received and said any action would depend upon results of its ongoing analysis....

Roche said more than 35 million patients have been exposed to orlistat therapy, and obesity is a high risk factor for hepatic injury. "The available information – post marketing spontaneous reports, clinical trial data and published literature as well as epidemiology data for drug-induced liver disease – does not suggest that orlistat is causally related to hepatic events."

Currently in Xenical’s package insert there are only rare reports of hepatic, or liver, injury.

The FDA has investigated Orlistat over concerns of rectal bleeding. See: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008

Any adverse reactions, such as hepatitis, liver injury or liver failure experienced with the use of Xenical or Alli should be reported to the FDA’s MedWatch Program

by phone at 1-800-FDA-1088,
by fax at 1-800-FDA-0178,
by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787,
or on the MedWatch website at www.fda.gov/medwatch.

Labels: Alli, FDA, hepatic, Hepatotoxicity, Liver, MedWatch, Orlistat, Xenical

posted by Jessica at 8:56 AM

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