FDA revises antidepressant warning
February 9, 2005 07:58

The Food and Drug Administration Wednesday revised its warning about antidepressants and their effect on children and teenagers taking such drugs.

In its earlier warning, the FDA had said drugs such as Zoloft, Paxil and Prozac could cause suicidal actions among children and teens.

Subject: FDA MedWatch: saquinavir/ritonavir (ritonavir boosted saquinavir) drug interaction with rifampin

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Roche and FDA notified healthcare professionals about an important drug interaction warning. Drug-induced hepatitis with marked transaminase elevations has been observed in healthy volunteers receiving rifampin 600 mg once daily in combination with ritonavir 100 mg/saquinavir 1000 mg twice daily (ritonavir boosted saquinavir). Roche advises prescribers that Rifampin should not be administered to patients also receiving saquinavir/ritonavir (ritonavir boosted saquinavir) as part of combination antiretroviral therapy (ART) for HIV infection.

Read the complete MedWatch 2005 safety summary, including a link to the "Dear Healthcare Professional" letter, at:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Invirase

Subject: FDA MedWatch: Agrylin (anagrelide hydrochloride) contraindicated in patients with severe hepatic impairment

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Shire and FDA notified healthcare professionals about changes to the CONTRAINDICATIONS and WARNINGS sections of the prescribing information for Agrylin (anagrelide hydrochloride), a medication approved for the treatment of thrombocythemia secondary to myeloproliferative disorders to reduce platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombohemorrhagic events. Pharmacokinetic studies have revealed an 8-fold increase in total exposure (AUC) to anagrelide hydrochloride in patients with moderate hepatic impairment. Use of anagrelide hydrochloride has not been studied in patients with severe hepatic impairment. Labeling changes include the contraindication to the use of Agrylin in patients with severe hepatic impairment. The WARNINGS section describes the need for dosage reduction in patients with moderate hepatic impairment and the necessity of monitoring these patients carefully for cardiovascular effects.

Read the complete MedWatch 2005 Safety Summary, including links to the Dear Healthcare Professional letter and highlighted label, at

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Agrylin

"Congress is considering placing federal restrictionson an individual's ability to hold a wrongdoer accountable. But lawmakers should stop and take a long, hard look at what happened when similar measures were enacted here in Texas just two years ago. When... (Read Article)