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In response to new safety concerns, the FDA announced label changes to 65 medications last month. Medications with new labels include:

Abilify (aripiprazole) Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection  
Amturnide (amlodipine/aliskiren/hydrochlorothiazide) tablets
Angeliq (drospirenone and estradiol) tablets
Aptivus (tipranavir) Capsules and Oral Solution
Avalide (irbesartan/hydrochlorothiazide) tablets 
Benicar (olmesartan medoxomil) Tablets   
Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
Cardiogen-82 (Rubidium Rb 82 Generator)   
Crestor (rosuvastatin calcium) Tablets
Crixivan (indinavir sulfate) Capsules
Diovan HCT (valsartan/hydrochlorothiazide) Tablets  
EES (erythromycin ethylsuccinate) Granules for oral suspension, Eryc (erythromycin delayed-release) capsules, Ery-Ped liquid and
PCE (erythromycin particles in tablets) 333 mg and 500 mg film coated tablets     
Elestrin (estradiol gel)
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) tablets
Famvir (famciclovir) Tablets
Hepsera (adefovir dipivoxil) tablets
Invirase (saquinavir mesylate) Capsules and Tablets
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
Lescol (fluvastatin sodium) Capsules
Lescol XL (fluvastatin sodium) Extended-Release Tablets
Letairis (ambrisentan) Tablets 
Lexiva (fosamprenavir calcium) tablets and oral suspension
Lipitor (atorvastatin calcium) Tablets
Livalo (pitavastatin) tablets   
Lotensin HCT (benazepril HCl and hydrochlorothiazide) Tablets
Mevacor (lovastatin) Tablets 
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets    
Norvir (ritonavir) oral solution and tablets
Orencia (abatacept) for injection   
Ozurdex (dexamethasone intravitreal) implant 
Patanase (olopatadine hydrochloride) Nasal Spray
Phendimetrazine tartrate SR 105 mg capsules  
Pravachol (pravastatin sodium) Tablets
Premarin (conjugated estrogens) Vaginal Cream
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) and Premphase (conjugated estrogens plus medroxyprogesterone acetate) tablets
Prezista (darunavir), Oral suspension
Reyataz (atazanavir sulfate) Capsules    
Rituxan (rituximab) Intravenous Injection
Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium) tablets
Simcor (niacin ER/simvastatin) Tablets
Tekamlo (aliskiren/amlodipine) tablets 
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
Valturna (aliskiren/valsartan) tablets
Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets   
Vasotec (enalapril maleate) Tablets   
Viracept (nelfinavir mesylate) Oral Powder
Vytorin (ezetimibe/simvastatin) Tablets 
Xalkori (crizotinib) Capsules
Yasmin (drospirenone/ethinyl estradiol) tablets
Zocor (simvastatin) Tablets   
Zyvox (linezoid) Tablets and Oral Suspension

 
Bloomberg News (12/1, Feeley) reported, Takeda Pharmaceutical Co. "may face as many as 10,000 lawsuits in US courts over allegations that its Actos [pioglitazone] diabetes drug causes bladder cancer, and a group of judges is preparing to decide where they should be consolidated." Several months ago, "US regulators found...that an analysis of a company-sponsored study showed some users of Actos, the world's best-selling diabetes medication, faced an increased risk of developing the potentially fatal disease." Bloomberg News adds that lawyers representing claimants assert that "The evidence linking Actos to bladder cancer "is unusually strong and clear."
 

Hundreds of miles and worlds away from the ongoing Los Angeles trial against Michael Jackson's doctor for administering a fatal dose of Propofol to the King of Pop, a jury in Las Vegas was listening to a very different case over the same drug earlier this month.

In the end, the jury awarded $182.5 million to three plaintiffs who contracted hepatitis C from tainted vials of the anesthesia during colonoscopy procedures. The outbreak of hepatitis C in Las Vegas, which infected nearly 100 patients, was reportedly caused by the re-use of Propofol vials for numerous patients. The makers of Propofol were held liable after they increased the vial size to save money, forcing doctors to use the vial on more than one patient.
 

Abbott Laboratories ($ABT) set aside $1.5 billion for a potential off-label marketing settlement with the U.S. Justice Department. If the settlement closes at $1.5 billion, it would rank as the second-largest off-label settlement in history, outranked only by Pfizer's $2.3 billion deal.

The potential legal settlement would resolve a longstanding investigation into Abbott's Depakote promotions. Whistleblower lawsuits allege that Abbott pushed the epilepsy drug, which is also approved for bipolar mania and migraine prevention, for a variety of unapproved uses. The company boasted that Depakote could treat autism, sexual compulsions, agitated and aggressive dementia patients, along with other conditions. The unapproved uses were promoted in a variety of U.S. healthcare settings, including long-term care and assisted-living facilities.

Read more about Abbott Settlement

 
A Los Angeles Superior Court jury in California awarded $48 million to a man who allegedly contracted a severe skin disorder and mouth blisters after taking the popular pain reliever Motrin. The man filed a negligence lawsuit against the drug manufacturer, claiming that his side effects were not adequately listed on the medication label. The man said that after using Motrin to get rid of aches and alleviate a fever, he noticed skin lesions and mouth blisters. The manufacturer has claimed that the side effects and conditions could be connected to aspirin and Tylenol.
 
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