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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 7 of 7. This is the beginning of the thread.
Posted by Phillipa on July 2, 2010, at 20:41:42
There are 13 meds now added to FDA list of Potentially bad meds that have already caused horrible results which did not turn up during clinical trials. Two Psych meds are providgil and xyrem, two antibiotics biaxin, and zithromax. Also premarin.Phillipa
From Medscape Medical News
13 Drugs on Latest FDA List for Safety Monitoring
Robert Lowes
July 2, 2010 A watch list of 13 drugs based on potential signs of serious risks or new safety information collected by the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) during the first quarter of 2010 has been released.The FDA is studying all of the drugs to determine the need for any regulatory action.
A drug's appearance on the watch list does not mean the agency has determined that the drug poses the health risk in question. Physicians should not stop prescribing the drug, and patients should not stop taking it, according to the FDA.
The FDA is evaluating 2 antibiotics azithromycin (Zithromax; Pfizer) and clarithromycin (Biaxin; Abbott) to find out whether they are associated with liver failure. Suspicions about azithromycin and liver failure are not new. The label for the antibiotic states that adverse events discovered after the drug entered the marketplace and for which a causal relationship may not be established include "abnormal liver function including hepatitis and cholestatic jaundice, as well as rare cases of hepatic necrosis and hepatic failure, some of which have resulted in death." During clinical trials, cholestatic jaundice was a rarely reported adverse effect.
Postmarketing adverse events for clarithromycin have included infrequent cases of sometimes severe, but usually reversible, hepatic dysfunction, including cholestatic hepatitis, with or without jaundice. There also have been rare and fatal cases of hepatic failure "associated with serious underlying diseases and/or concomitant medications," according to the drug label. Cholestatic jaundice did not emerge as an adverse effect in clinical trials.
Two other antibiotics made it on the latest watch list. AERS turned up reports of pyloric stenosis linked to azithromycin extended release 2 g (Zmax; Pfizer) and pulmonary eosinophilia and eosinophilic pneumonia linked to daptomycin (Cubicin; Cubist Pharmaceuticals).
FDA Studying Anticoagulant to Determine Whether It Causes Blood Clots
Three other medications on the watch list are in the cardiovascular camp. The anticoagulant prasugrel (Effient; Eli Lilly), is being watched on account of thrombotic thrombocytopenic purpura a rare and life-threatening disorder that causes clots to form in small blood vessels throughout the body. The drug's label warns that this disorder emerged as an adverse effect during clinical trials. Heartwire recently reported that researchers continue to debate whether the medication increases the risk for cancer.
Another drug, dronedarone (Multaq; Sanofi-Aventis), used to treat atrial fibrillation and atrial flutter, has come under surveillance because of reports of congestive heart failure. As reported by Heartwire, clinicians have considered dronedarone a safer alternative to amiodarone (Cordarone; Wyeth-Ayerst; Pacerone; Upsher-Smith) for patients with atrial fibrillation.
The third cardiovascular drug on the watch list is ranolazine (Ranexa; Gilead), prescribed for patients with angina. Here, the FDA is investigating reports of torsades de pointes a ventricular tachycardia that can lead to sudden death.
Two medications prescribed for narcolepsy modafinil (Provigil; Cephalon) and sodium oxybate (Xyrem; Jazz Pharmaceuticals) are under study for a possible association with convulsions. Physicians prescribe modafinil to counteract excessive sleepiness caused by narcolepsy, sleep apnea, or shift work. Likewise, sodium oxybate reduces daytime sleepiness, as well as the number of cataplexy attacks suffered, in patients with narcolepsy.
Perhaps the most well-known product on the watch list is the blend of estrogens marketed as Premarin (Wyeth), used to treat symptoms of menopause. It landed on the list based on reports of angioedema.
Potential Signals of Serious Risks/New Safety Information Identified by AERS, First Quarter 2010
Product Name: Active Ingredient (Brand Name) or Product Class Potential Signal of a Serious Risk/New Safety Information
Azacitidine (Vidaza; Celgene) Acute febrile neutrophilic dermatosis (Sweet's syndrome)
Azithromycin (Zithromax) Liver failure
Azithromycin extended release 2 g (Zmax) Pyloric stenosis
C1 esterase inhibitors (Cinryze; ViroPharma; Berinert; CSL Behring) Thromboembolic events in patients with certain thrombogenic risk factors
Clarithromycin (Biaxin) Liver failure
Daptomycin (Cubicin) Pulmonary eosinophilia, eosinophilic pneumonia
Dronedarone hydrochloride (Multaq) Congestive heart failure
Estrogens, conjugated (Premarin) Angioedema
Modafinil (Provigil) Convulsion
Prasugrel hydrochloride (Effient) Thrombotic thrombocytopenic purpura
Ranolazine (Ranexa) Torsades de pointes
Sodium oxybate (Xyrem) Convulsion
Temsirolimus (Torisel; Pfizer) Infusion site extravasationThe current list of drugs is available on the FDA Web site.
The watch list of drugs generated by AERS during the fourth quarter of 2009, as well as previous lists, are also available.
Posted by fayeroe on July 2, 2010, at 23:04:18
In reply to 13 Meds On FDA LIst Providgil and Xyrem Too Antibi, posted by Phillipa on July 2, 2010, at 20:41:42
wow, if premarin is dangerous, a lot of post-menopausal women sure are going to sweat and chill, huh?
Phillipa, how do you find these great articles?
Posted by Phillipa on July 3, 2010, at 0:06:35
In reply to Re: 13 Meds On FDA LIst Providgil and Xyrem Too Antibi » Phillipa, posted by fayeroe on July 2, 2010, at 23:04:18
Come on my nursing online newsletter. I find this is the quickest way to find out what's going on. Thankful using bioidentical hormones. New study says safe in low doses. Not happy about the biaxin as took for two years for lymes and infection control doc just informed me that this drug was the cause of the loss of my taste and smell. Phillipa How do you find them?
Posted by fayeroe on July 3, 2010, at 0:22:09
In reply to Re: 13 Meds On FDA LIst Providgil and Xyrem Too Antibi » fayeroe, posted by Phillipa on July 3, 2010, at 0:06:35
oh......you get a nursing newsletter online. i do my research on the net.......just keep looking til i find what i need.
Posted by Phillipa on July 3, 2010, at 19:24:01
In reply to Re: 13 Meds On FDA LIst Providgil and Xyrem Too Antibi » Phillipa, posted by fayeroe on July 3, 2010, at 0:22:09
Problem is that you don't know which sites are legit. Sometimes a lot of conflicting info. This way I at least know that this is what the professionals are reading as also pharmacists and docs have access to this site. Have to enter your license number to enroll and can also get CME's for educational purposes. Phillipa Pub med is good
Posted by jade k on July 5, 2010, at 17:28:41
In reply to Re: 13 Meds On FDA LIst Providgil and Xyrem Too Antibi » Phillipa, posted by fayeroe on July 3, 2010, at 0:22:09
> oh......you get a nursing newsletter online. i do my research on the net.......just keep looking til i find what i need.
Yeah, I have been doing the same recently.
I go through the "favorites" I've saved...and I just keep digging til I find what I'm looking for.
I forgot how much relevant info I had stored!~Jade
Posted by jade k on July 10, 2010, at 16:26:45
In reply to 13 Meds On FDA LIst Providgil and Xyrem Too Antibi, posted by Phillipa on July 2, 2010, at 20:41:42
Throw us some GOOD news from one of your psych journals!
~Jade
This is the end of the thread.
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