FDA - Boxed Warnings
FDA New Boxed Warnings February 2011
Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin hydrochloride), and Avandaryl (rosiglitazone maleate/glimepiride) Tablets
(Diabetes medication)
BOXED WARNING WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION
Source : FDA (March 2011)
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Risk of fluoroquinolone-associated Myasthenia Gravis Exacerbation February 2011 Label Changes for Fluoroquinolones
(a group of antibiotics which exert their antimicrobial effects by inhibiting bacterial DNA gyrase. They are effective primarily against gram-negative organisms)
Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.4
* Exacerbation of myasthenia gravis
Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)5
* Exacerbation of myasthenia gravis
Factive (gemifloxacin mesylate) Tablets6
* Exacerbation of myasthenia gravis
Floxin (ofloxacin) Tablets7
* Exacerbation of myasthenia gravis
Levaquin (levofloxacin) Tablets, Oral Solution and Injection8
* Exacerbation of myasthenia gravis
Noroxin (norfloxacin) Tablets 9
* Exacerbation of myasthenia gravis
Proquin XR (ciprofloxacin) Extended-Release Tablets10
* Exacerbation of myasthenia gravis
BOXED WARNING
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Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin hydrochloride), and Avandaryl (rosiglitazone maleate/glimepiride) Tablets
(Diabetes medication)
BOXED WARNING WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION
- A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with a statistically significant increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, showed a statistically non-significant increased risk of myocardial infarction and a statistically non-significant decreased risk of death. There have been no clinical trials directly comparing cardiovascular risk of Avandia and Actos (pioglitazone, another thiazolidinedione), but in a separate trial, Actos (when compared to placebo) did not show an increased risk of myocardial infarction or death
- Heart Failure in Observational Studies of Elderly Diabetic Patients Comparing Avandia to Actos ...
- Meta-Analysis of Major Adverse Cardiovascular Events in a Group of 52 Clinical Trials (updated)
- ...Other studies suggest that this risk may also apply to men, although the risk of fracture among women appears higher than that among men.
- The use of Avandia in combination with insulin may increase the risk of myocardial infarction.
Source : FDA (March 2011)
Link to Source
Risk of fluoroquinolone-associated Myasthenia Gravis Exacerbation February 2011 Label Changes for Fluoroquinolones
(a group of antibiotics which exert their antimicrobial effects by inhibiting bacterial DNA gyrase. They are effective primarily against gram-negative organisms)
Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.4
* Exacerbation of myasthenia gravis
Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)5
* Exacerbation of myasthenia gravis
Factive (gemifloxacin mesylate) Tablets6
* Exacerbation of myasthenia gravis
Floxin (ofloxacin) Tablets7
* Exacerbation of myasthenia gravis
Levaquin (levofloxacin) Tablets, Oral Solution and Injection8
* Exacerbation of myasthenia gravis
Noroxin (norfloxacin) Tablets 9
* Exacerbation of myasthenia gravis
Proquin XR (ciprofloxacin) Extended-Release Tablets10
* Exacerbation of myasthenia gravis
- Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.
- Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)
- Noroxin (norfloxacin) Tablets
- Levaquin (levofloxacin) Tablets, Oral Solution and Injection
- Proquin XR (ciprofloxacin) Extended-Release Tablets
- Floxin (ofloxacin) Tablets
- Factive (gemifloxacin mesylate) Tablets
BOXED WARNING
- Fluoroquinolone products may exacerbate muscle weakness in persons with myasthenia gravis. Avoid fluoroquinolone products in patients with known history of myasthenia gravis
- Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
- Exacerbation of myasthenia gravis
- Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
- Tell your healthcare provider about all your medical conditions, including if you have a disease that causes muscle weakness (myasthenia gravis).
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