Monthly Archives: February 2008

Tysabri (natalizumab) and liver injury

Posted on February 28, 2008 by admin

FDA news: Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The … Continue reading →

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Patient reporting of adverse drug reactions

Posted on February 18, 2008 by admin

The BBC report on the MHRA’s drive to increase public participation in The Yellow Card scheme. Dr June Raine, from the MHRA, said: “We are keen to let people know that whilst their medicines have important benefits, they may also … Continue reading →

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Severe reactions to Botox (botulinum toxins)

Posted on February 11, 2008 by admin

FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both … Continue reading →

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Duphaston (dydrogesterone) withdrawal

Posted on February 5, 2008 by admin

Duphaston is to be withdrawn for commerical reasons: Duphaston/Duphaston HRT (dydrogesterone) is to be withdrawn from the market from March 2008 for commercial reasons. Duphaston was licensed for use in several indications, including threatened or recurrent miscarriage, dysfunctional uterine bleeding, … Continue reading →

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Drug Safety Update February 2008

Posted on February 5, 2008 by admin

The MHRA have published Drug Safety Update February 2008, including: Statins: class effects identified Varenicline: safety update Carisoprodol and meprobamate: risks outweigh benefits Yellow Card scheme update Reporting by patients and the public Biosimilar products Duphaston/Duphaston HRT (dydrogesterone): withdrawal of … Continue reading →

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Varenicline – FDA Update

Posted on February 2, 2008 by admin

The FDA have updated the prescribing information for varenicline: FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These … Continue reading →

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