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Archive for the ‘ Drug Injury ’ Category

Jun

FDA Finds New Outlet for Consumer Drug Information

The U.S. Food and Drug Administration (FDA) and the website Drugs.com (www.drugs.com) have teamed to broaden the reach of FDA’s consumer health information.

A new partnership forged by the two entities provides consumers with a joint resource on Drugs.com’s site that features FDA Consumer Update articles, videos, and slideshows. It will also bring FDA health information to Drugs.com’s mobile phone platform.

“The partnership with Drugs.com means that reliable, useful, and timely health information will be available to an even wider audience,” says Beth Martino, FDA’s associate commissioner for external affairs. “Partnerships like this are an important part of FDA’s effort to ensure the public has easy access to reliable, useful information that can help people protect and improve their health.”

With more than 12 million unique visitors each month, this terrific site seeks to provide comprehensive drug information online, and to assist in the reduction of medication errors. Featured services include an A-to-Z Drug List, a Pill Identifier (for those stray pills you find in the bottom of your bathroom cabinet), Clinical Trial Results, Pregnancy Warnings, and many more.

To read the FDA’s take on this new partnership, click here: Drugs.com Furthers Reach of FDA Consumer Health Information.

Unfortunately, even with the best information, drug injuries can happen. For example, there may be a prescribing error, or a defect in the manufacturing process. If you believe that you have been injured by a prescription or over-the-counter medication, please seek help from a physician. If you have legal questions, visit the HensonFuerst Drug Injury information page, or call one of our drug injury lawyers at 1-800-4LAW-MED. If you have questions, HensonFuerst has answers.

Popularity: 19% [?]

May

Weight Loss Drug May Cause Severe Liver Injury

The weight loss drug orlistat is sold over-the-counter under the brand name Alli, and by prescription under the brand name Xenical. Today, the FDA announced a label change to inform consumers that taking these medications can, in rare instances, cause severe liver injury.

This is quite a different story from the relatively benign side effects reported when the drug was first approved. Back then, the “worst” side effects were flatulence and an inability to control stool, also known as incontinence. (from MedicineNet)

According to the FDA’s review, there have been dozens of cases of serious liver injury, and at least 6 cases of liver failure associated with use of either Xenical or Alli. Two patients died from liver failure, and three required liver transplantation.

The FDA is reluctant to say that the drug definitely caused these cases, saying that other factors might be involved… but these injuries were reported as “adverse events” that happened to people after they took orlistat.

WHAT YOU SHOULD DO

If you are taking orlistat, talk to your doctor about what the new labeling means for you. If you experience any of the signs or symptoms of liver injury, stop taking the drug and contact your doctor immediately. These include:

itching
yellow eyes or skin
fever
weakness
vomiting
fatigue
dark urine
light-colored stools
loss of appetite

If you have any side effect of taking Xenical or Alli, you can report them to the FDA by calling 1-800-FDA-1088, or by visiting http://www.FDA.gov/medwatch (and click on “How to Report).

Click here to read more: FAQs about Orlistat.

If you believe that you have developed liver injury as a result of taking Xenical or Alli, seek medical attention immediately. If you want to explore your legal options, don’t hesitate to call the lawyers of HensonFuerst. If you have questions, HensonFuerst has answers.

Popularity: 26% [?]

May

URGENT RECALL: Infant & Children’s Liquid Medications

McNeil Consumer Healthcare has issued a voluntary recall of all of its over-the-counter liquid infant’s and children’s Tylenol, Motrin, Zyrtec, and Benadryl. While the company has said that no one has been injured, there is the potential for serious injury. Stop using these products IMMEDIATELY.

The company reports that some products may contain “a higher concentration of active ingredient than is specified” (dangerous!), inactive ingredients that don’t “meet internal testing requirements,” and possibly particle contaminants. They don’t say what those contaminants might be, but another pharmaceutical company (Hospira) had to halt production of two drugs due to machinery residue that got into the products. Nothing like tiny bits of stainless steel to make a person feel better….

According to the McNeil recall notice (available here: McNeil recall notice):

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.

The U.S. Food and Drug Administration (FDA) has an FAQ page devoted to this recall: FDA info for parents. Two of the most important questions and answers from that site:

I gave my child some of the medication. What do I do? Is my child at risk?

According to the information the FDA has received at this time, the potential for serious medical problems is remote. If your child exhibits any unexpected symptoms after use of any of the recalled products, contact your healthcare provider.

If I think my child may be having an adverse reaction to one of the products involved in this recall, who should I notify?

Adverse reactions or quality problems experienced with the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax, using the contact information at the bottom of this sheet. The agency asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

And, of course, HensonFuerst is always available to answer your legal questions about drug injuries or defective product injuries. This is an enormous recall affecting the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. If you think your child has had a bad reaction to one of the recalled medications, feel free to call us. If you have questions, HensonFuerst has answers.

Popularity: 30% [?]

Apr

Hospira Recall Involves Two NC Manufacturing Sites

It’s a case of twos: Two pharmaceuticals manufactured in two North Carolina plants have been recalled for a second time in six months due to contamination after equipment failure.

The products (both by Hospira, Inc.) are a numbing agent called Propofol, and an intravenous nutritional product called Liposyn–both sold only to doctors and hospitals. The drugs, which are manufactured in Rocky Mount and Clayton, NC, were recalled on November, 6, 2009… and again on April 16, 2010.

The problem in both recalls is the same: Stainless steel particulates made their way into the pharmaceuticals during the manufacturing process. According to a Hospira press release from the first recall (made available by the FDA):

“Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.” [emphasis added]

After two inspections by the U.S. Food & Drug Administration (FDA) in early 2010, the FDA issued a warning letter to Hospira citing several inspection violations, with the conclusion that the manufacturing problems continued. This prompted the April 16, 2010, national recall.

According to a report on Raleigh’s WRAL website, Hospira officials said the company is still manufacturing the drugs at the Clayton facility and are waiting for approval from the Food and Drug Administration before further shipments.

If it’s true that they are continuing to manufacture the recalled products before receiving FDA approval, that’s pretty frightening. And potentially dangerous.

Although there have not yet been any reports of patients being harmed by the recalled products, that doesn’t mean that we’re in the clear. If you were a patient and received either of these products while in a hospital or under a doctor’s care, you probably have a lot of questions. If you are worried that you may have suffered harm after receiving Propofol or Liposyn in the past 8 months or so, call HensonFuerst Attorneys.

If you have questions, HensonFuerst has answers.

Popularity: 29% [?]

Apr

Treatment Center Kills Man with Lethal Drug Overdose

The Raleigh News & Observer reports that a man being treated in a state-run drug treatment center in Butner, NC, after staff members gave him a lethal dose of methadone.

The story took a frightening turn when we learned that there was no reason for the man to have been prescribed methadone in the first place. Methadone is used to treat heroin addiction…but the patient was not addicted to heroin.

Apparently, he survived a low dose of methadone, but a physician increased his dosage. As the victim lay unconscious in his bed, a nurse assumed he was sleeping and ignored this blatant symptom of overdose. The man was found bleeding and unconscious in a bathroom after midnight by another patient.

It raises so many questions: Where was the hospital staff while this man was suffering? Is it common to have patients missing from their beds at midnight, and not be searched for? Are there no checks and balances for physicians and nurses who seem to be running on auto-pilot? Do any of the staff of state-run hospitals care enough to give proper treatment to their patients?

HensonFuerst is outraged by this type of treatment. We devote our lives to helping people who have been injured in this way… but we would be thrilled if these types injuries and deaths never happened in the first place.

While the newspaper article said that it was unclear whether there would be any disciplinary action against the staff, it would be a travesty if no action were taken. Whatever happened to the oath of “do no harm”?

If you or one of your loved ones have been injured while in any medical care facility, call us. HensonFuerst is on your side.

Popularity: 28% [?]

Mar

FDA Warning about Zocor

Today, the U.S. Food and Drug Administration (FDA) warned that taking the popular cholesterol-lowering drug simvastatin may–in some cases and in some people–cause muscle damage. While this sounds relatively harmless, the damage sometimes progresses to a severe form called rhabdomyolysis. With this disease (often called “Rhabdo” for short), the damaged muscles release proteins into the blood, which has the potential to cause kidney damage, kidney failure, and death.

You heard right: Taking a drug to lower your cholesterol has the potential to cause death from kidney damage.

Simvastatin is sold under the brand name Zocor, and is paired with other drugs in Vytorin and Simcor.

Rhabdo is a rare but real threat. As reported in the Los Angeles Times, the risk of muscle damage is higher for people who take 80 milligram doses of Zocor… people of Chinese descent…and when simvastatin is combined with other drugs, including niacin and amiodarone (brand names Pacerone and Cordarone). For a full list of potentially dangerous drug combinations, see the LA Times article here.

If you currently take Zocor, do not stop taking the medication without first talking with your doctor. If you have muscle pain or concerns about your medication, make an appointment with your doctor as soon as possible.

And if you have been injured from Zocor or other medications, and want to talk with a lawyer, call us for a free consultation. At HensonFuerst, if you have questions, we have answers.

Popularity: 31% [?]

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