Mobile Personal Injury Lawyer - FDA & Prescription Drugs

FDA finds E. Coli in Nestle Cookie Dough Sample...

Troy Schwant — Tue, 30 Jun 2009 13:25:15 GMT

How many times have you herad that "one more cookie won't kill you"? Well today's news release by the FDA, shows that this may not be true.

Here is the full report:

www.foxnews.com/story/0,2933,529531,00.html

The Food and Drug Administration said Monday a sample of raw cookie dough collected at a Nestle USA manufacturing plant last week has tested positive for E. coli.

Nestle voluntarily recalled all Toll House refrigerated cookie dough products made at the Danville, Va., factory earlier this month after the FDA told Nestle it suspected consumers may have been exposed to E. coli bacteria after eating the dough raw.

The FDA and the federal Centers for Disease Control have been investigating whether the cookie dough was the source of the E. coli outbreak which has sickened 69 people in 29 states, according to the latest CDC data. E. coli is a potentially deadly germ that can cause bloody diarrhea, dehydration and, in the most severe cases, kidney failure.

The FDA says the sample of Toll House refrigerated prepackaged dough was manufactured at the plant on Feb. 10.

In a statement, Nestle said the sample that tested positive came from a 16-ounce Toll House refrigerated chocolate chip cookie dough bar. The product had a "best before June 10 2009" label.

"We are very concerned about those who have become ill ... and deeply regret that this has occurred," the company said in the statement.

The company also reiterated that consumers can return the recalled products to their local grocer for a full refund.

FDA spokeswoman Stephanie Kwisnek says the FDA is working with the Glendale, Calif.-based unit of Switzerland-based Nestle SA to find the source of the contamination. Nestle said it will continue to work "closely and in full cooperation" with the investigation.

Besides the Toll House products, Nestle also makes a variety of refrigerated pastas and pasta sauces at the plant.

The company shut down production in the cookie dough section of the plant when it issued the recall. That section remains closed, but the company is still manufacturing the pasta and pasta sauces in a separate section of the plant.

Originally posted at InjuryBoard by Troy Schwant

FDA warns against using certain nasal cold remedy products...

Troy Schwant — Wed, 17 Jun 2009 13:09:57 GMT

According to this report, the FDA warns that using certain Zicam nasal cold remedies can reduce and in some cases completely eliminate the sense of smell in some users.

Please check your medicine cabinet and be sure that you or a loved one isn't using these products.

Review the full article here:

www.cnn.com/2009/HEALTH/06/16/zicam.fda.warning/index.html

Originally posted at InjuryBoard by Troy Schwant

Placebo Prescribing: a surprisingly common lie and its risk

Trevor Reid — Fri, 24 Oct 2008 14:54:53 GMT

National Public Radio reported today that prescription of placebos by American doctors may be a common practice. Placebos are a form of off label use where the medicine is not shown to treat a patient's diagnosed ailment, but the influence on the particular patient is hoped to be positive--sometimes from nothing more than positive thinking and expectations. And the majority of doctor's surveyed find it acceptable, according to news from a study of internists and rheumatologists published in the most recent edition of the British Medical Journal.

NPR's report quotes Robert Sade, a surgeon, suggesting that such prescriptions are a grayish area in medical ethics. The American Medical Association's position is summed up this way:

"[I]f doctors want to use placebos, they should tell patients that one or more of the pills they're getting is not specifically designed for their illness, but that some have found it helpful."

I shudder. Outside of research where subjects are told upfront they may receive placebos, the practice is clearly a problem. First, autonomy and informed consent are paramount in our relationships with physicians, dentists, and every professional for that matter. Only you can take a meaningful measure of your own quality of life and assess whether any treatment worthwhile in light of the disclosed risks and drawbacks. In the process you rely on your doctor to be honest with you--a placebo is simply a lie. It undermines the entire basis of autonomy.

But, philosophical nuances aside, there is a second, more practical concern embedded in this news about placebo prescribing. Many of us are under the care of more than one doctor over the course of our lives. If doctors aren't absolutely open with patients how can patients convey an accurate picture of their health to another provider when asked?

Autonomy is so important to me personally that I even write "Patient expects complete candor and autonomy" in the "other concerns" section whenever I fill out a new patient intake form.

Once in a while a doctor's negative reaction to this has raised a red flag and I sought care elsewhere. More often it has lead to clear expectations, a better bedside manner, and the foundation for robust trust and openness to follow. Of course, within this framework I respect my doctors' professional knowledge. After all, that's why I hired them.

Originally posted at InjuryBoard by Trevor Reid

Off Label Uses of Prescription Drugs

Pete Burns — Thu, 09 Oct 2008 13:50:00 GMT

Off label use is a drug is prescribed for a purpose, at a dose, or through a route of administration that has not been approved by the FDA. After clinical testing the FDA approves drugs for specific conditions and in specified dosages. The FDA does not control the practice of medicine. Once the FDA approves a drug it is now available for the doctor to prescribe for whatever purpose and in whatever dosage the doctor deems appropriate. It is common practice for doctors to prescribe drugs for conditions and in dosages for which the FDA has not tested the drug. The patient has a right to know if any drug which has been prescribed for him is being prescribed off label. Ask the doctor and review the package insert to make sure the drug you are taking has been approved for the purpose and in the amount prescribed for you.

Originally posted at InjuryBoard by Pete Burns

Durogesic Patch - Informed Consent

Pete Burns — Sun, 05 Oct 2008 13:40:11 GMT

We represent a lady who has experienced brain damage as the result of inappropriate prescription of a Durogesic Patch. She had one day surgery and was sent home wearing a Durogesic Patch. The manufacturer’s warns against using the Durogesic Patch unless the patient is under supervision. Neither the patient not the family were warned of the need to monitor her or that this was an off label use of the Durogesic Patch. Twenty four hours later she was unconscious. During the night the patch had caused a reduction in her heart rate which impaired the oxygen flow to her brain. Informed consent may have prevented this tragedy.

Originally posted at InjuryBoard by Pete Burns

Medical Malpractice

Pete Burns — Thu, 01 May 2008 11:51:28 GMT

We represent the mother of a 14 year old girl in a wrongful death case. The child was having headaches so her mother took her to the defendant neurologist. He prescribed 200 mlg of desipramine (off label) without doing any kind of a cardiac work up. The child died of a desipramine overdose 33 days later. The defendant surrendered his license after charges were filed in connection with unrelated malpractice upon eleven of his patients. Desipramine is a dangerous drug and if a doctor prescribes it for your child get a second opinon.

I am preparing to depose Dr. Stephen D Silberstein of Philadelphia Pennsylvania who is testifying in behalf of the neurologist. I would be interested in any experience anyone has had with Dr. Silberstein and I will be happy to make his deposition available to anyone who wants it upon request.

Originally posted at InjuryBoard by Pete Burns

Baxter Recalls Heparin After Allergic Reactions

Chrissie Cole — Fri, 22 Feb 2008 23:30:38 GMT

On Monday, Baxter announced they are temporarily suspending the production of the drug Heprin, after 350 negative reactions have been reported in conjunction with the drug.

The active ingredient in Heprin, a blood-thinning medication, was reportedly made at a Chinese facility that the U.S. Food and Drug Administration (FDA) failed to inspect, according to a report in the Wall Street Journal.

Baxter and the FDA both said they are unclear if the product from a Chinese supplier, is tied to allergic reactions to the drug, Heparin, which has resulted in four deaths.

An FDA spokeswoman told the Journal that the Chinese plant "was supposed to be inspected" but was not due to "human error, and inadequate information-technology systems." The spokeswoman added that, "preparations are being made to perform an inspection as soon as possible," according to the report.

Originally posted at InjuryBoard by Chrissie Cole

FDA Approves Update to Ortho Evra Patch Label

Chrissie Cole — Fri, 18 Jan 2008 00:39:07 GMT

The U.S. Food and Drug Administration (FDA) has approved revisions to the current Ortho Evra Contraceptive Patch label.

The updated labels will reflect results from a new study that found users of the patch were at an increased risk of developing serious blood clots (also known as (VTE - venous thromboembolism), than those women who use birth control pills.

The study was conducted by Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson & Johnson and included women between15-44.

"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

The FDA revised the label for Ortho Evra, in September 2006, to warn women of the risk of VTE based on two studies. One study, by i3 Ingenix, showed that some women using the patch were at a two-fold greater risk for developing VTE.

The other study, by BCDSP, showed they were not at an increased risk compared to women taking birth control pills that contain 30-35 micrograms of estrogen and progestin norgestimate.

Originally posted at InjuryBoard by Chrissie Cole

FDA Warns About False Claims for Some Menopause Therapy Drugs

Chrissie Cole — Wed, 09 Jan 2008 23:00:33 GMT

The FDA has sent warning letters to seven pharmacies ,within the last week regarding false or misleading claims about their made-to-order products, commonly marketed as bio-identical hormone replacement therapy (BHRT).

The FDA has also agreed to create public-awareness campaigns designed to dispel myths about "bio-identicals."

Some pharmacies that make "bio-identicals" say they are all-natural and have fewer side effects, but "there is no credible scientific support for these claims," Deborah Autor, compliance director for the FDA's Center for Drug Evaluation and Research, said on a conference call with reporters.

There are an estimated 3,000 compounding pharmacies in the United States. The seven pharmacies given warning letters are in Pennsylvania, California and Texas.

Patients that use compounded hormone therapy drugs are advised to seek medical advice from their doctors about hormone therapy options.

Originally posted at InjuryBoard by Chrissie Cole

Merck Recalls 1 Million Doses Of Childhood Vaccine

Chrissie Cole — Thu, 13 Dec 2007 00:30:21 GMT

Merck & Co., a popular drug manufacturer, announced a recall of more than one million vaccines due to a contamination risk.

U.S. Health officials say the recall is not a health threat. Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference.

The recalled vaccine, HIB, is used to protect babies and children from meningitis and pneumonia. Merck announced the recall after testing at their Pennsylvania factory discovered a sterilization problem. At this time officials are unsure if the contamination involves a bacteria or virus.

Concerned parents are advised to contact their child's doctor for further information.

The recall is likely to heighten a debate over childhood vaccines and their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown such a connection.

This week New Jersey took a controversial step toward becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from parents.

Originally posted at InjuryBoard by Chrissie Cole