Bring on a Pharmacist... Please

WASHINGTON –  Federal health officials are alerting doctors to the recall of an injectable antibiotic made by B. Braun Medical, due to floating particles found in vials of the drug. The Food and Drug Administration posted the notice late Tuesday, warning health professionals that the company has recalled lot H3A7444 of its Cefepime for Injection USP and Dextrose Injection USP. Visible particles were found in a sample from the lot, including specs of metal, cotton fiber and hair.

The agency warned that using the drug could result in blood clots causing stroke, heart attack and other catastrophic problems.

The drug was distributed to hospitals, pharmacies and medical suppliers nationwide, according to the agency's release.

Patients experiencing health problems should contact their physician and report all issues to the company at 1-800-854-6851.

Hearing the newsanchor mispronounce cefepime threw me off.  Initially thought he was talking about some drug I had never heard of.  If news can bring on a Dr. Oz or the Doctors show, how about bringing in a pharmacotherapy specialist to discuss medications?

What is REMS?

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if the Food and Drug Administration (FDA) determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system. This resource center contains information for pharmacists, patients, and other healthcare professionals about REMS, and the specific requirements for drugs that require a REMS. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.  Additional REMS Information.

Check out this FDA website to obtain more information.

Depakote and Abbott's $1.6 Billion Mistake

Abbott never had FDA approval to promote Depakote for aggression and agitation in the elderly or schizophrenia. The total includes a criminal fine of $700 million and civil settlements with the states and federal government totaling $800 million. Abbott pleaded guilty to a criminal misdemeanor for misbranding the medication. Abbott is also going to pay 45 states $100 million to resolve liability with consumer protective laws. Luckily the Justice Department found no deaths due to this crime.

The company admitted that from 1998 through 2006, it "maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use," the Justice Department said in a news release.

"In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use."

Heaphy said Abbott earned about $13 billion from Depakote sales during the period investigated, but he said it was difficult to determine how much of that was the result of sales for illegal purposes. He expressed confidence that, once the fines are factored in, Abbott will not have profited from the improper practices.

Um... Ok. $13 billion minus $1.6 billion equals a profit.

No wonder this will keep happening.

Glaxo Whistle-Blower Lawsuit: Bad Medicine - 60 Minutes - CBS News

Glaxo Whistle-Blower Lawsuit: Bad Medicine - 60 Minutes - CBS News. I sat mesmerized during this television program the other evening.  Big Pharma finally busted for the things that you wouldn't really expect in medicine in America...  negligence among other unspeakable things.  The whistleblower, Eckard, is now a multimillionaire.  I guess we Americans have to have an incentive to be able to do what she did.  I personally can't imagine how hard it would be to not be looking over my shoulder for what she did...  tell the truth.  Should we be PAID to tell the truth?  I don't think so.  Part of that money, or the majority of it really, comes from those that pay for their medicines at high prices.  That lawsuit won't backrupt the company by any means.  We are definitely a suing bunch expecting a big windfall of money as soon as someone goofs up.

Under the whistleblower law, Eckard was rewarded with a percentage of the millions that the government recovered in the fraud suit. Her portion comes to $96 million.

"You know that there are people watching this interview who are saying, 'Well, she did it for the money,'" Pelley pointed out. "And to them you say what?"

"That I hope and I pray that their mothers and their brothers and their children have safer medicine today than they had before I filed that lawsuit," Eckard replied. "And I believe they will. Right? I believe they will."

The usual...

Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.