Articles Posted in Drug Warnings

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Myland has announced the recall of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg.

It is possible that a number of tablets from the affected lots may exceed the weight requirement, essentially causing higher dosage of acetaminophen, resulting in consumers possibility taking more than the intended acetaminophen dose.

This includes product with the following NDC numbers and lot numbers beginning with the letter “C” – The lot number can be found on the side of the manufacturer’s bottle.

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What happens when a drug company fails to warn of the risk of the product and the prescribing doctor later learns of the risk and continues to prescribe the drug?

The 2nd Circuit took this issue on in McElroy v. Eli Lilly. In this case, the plaintiff’s psychiatrist continued prescribing of Zyprexa – a drug that treats bipolar disorder and schizophrenia – even after being told of Zyprexa’s diabetes risk. In fact, the doctor even upped the dosage of the drug after March 1, 2004 (the date Eli Lilly sent a “Dear Doctor” letter to the medical community warning of the diabetes risks associated with the Zyprexa).

The 2nd Circuit found that plaintiff”s “continued prescription of Zyprexa for more than two years after the medical community knew or should have known about the drug’s risks indicates that his prescribing decision was not affected by those risks.”

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The U.S. Food and Drug Administration (FDA) is currenlty

reviewing reports of children who have developed serious adverse effects, or who have died, after taking codeine for pain relief after procedures such as a tonsillectomy and/or adenoidectomy. There have been three pediatric deaths and one life-threatening case of respiratory depression recently documented.

The reported cases involve children, ages two to five, that had evidence of an inherited (genetic) ability to convert codeine into life-threatening or fatal; amounts of morphine in the body. Each of the children had received doses of codeine that were within the typical dose range.

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A federal court in Connecticut kept alive a Prempro breast cancer wrongful death case, denying Wyeth’s pretrial motion for summary judgment. Plaintiffs’ brought the classic Prempro case against Wyeth who makes the hormone therapy drugs Premarin, an estrogren, and Prempro, a combination of Premarin and a progestin, which are both prescribed to combat the symptoms of menopause. Plaintiffs’ wrongful death lawsuit claims that a woman died of breast cancer using these drugs that were unreasonably dangerous and that they lacked adequate warnings.

Wyeth argued that the Connecticut Product Liability Act does not recognize strict liability design defect cases, contending that the infamous common K of Section 402A of the Second Restatement of Torts.

Section 402A imposes strict liability for defective products that are found to be unreasonably dangerous to the end user. Comment K suggests an exception for products that are “unavoidably unsafe.”  This Connecticut federal court found that comment K should not be applied uniformly to prescription drugs. Instead, each drug should be considered on a case-by-case basis.

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The FDA has notified healthcare professionals that it is aware of a study published in the New England Journal of Medicine yesterday, that reports a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax), as compared to individuals treated with amoxicillin, ciprofloxacin, or no drug at all.

Azithromycin belongs to a class of antibacterial drugs called macrolides. Macrolides have been associated with cardiovascular effects; specifically, prolongation of the QT interval. The FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.

The FDA has announced that it is reviewing the results from this study, and will communicate any new information on azithromycin and this study, or the potential risk of QT interval prolongation after the agency has completed its review.

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Most drug injury lawyers assume that the statute of limitations begins to run when the appropriate warning is placed on the drug or medical device. In mass tort cases, if you have a case that is past the state’s statute of limitations, you can’t find a lawyer to file your case for you.

I’m not a fan of strict construction of statute of limitations. The bright line leads to too many unjust results. Plaintiffs file cases all the time that get delayed and delayed by defense tactics. There is no reverse statute of limitations, the “Geez, you guys drug this thing out so long and the witnesses have forgotten everything so liability is established” rule. So not erring on the side of plaintiffs is a long established tradition in the law that no one even questions anymore. But that does not make it any less dumb.

Oh, right, back to the blog post. The New Jersey Supreme Court ruled that Accutane ulcerative colitis plaintiff timely filed her lawsuit because she had no reason to know that Accutane could cause inflammatory bowel disease in spite of the fact that a warning had been issued earlier in 2003.

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A recent study has found that there is new evidence that statins could increase women’s risk factor for type 2 diabetes.

Statins, often called wonder drugs, are medicines taken to lower cholesterol levels. Zocor, Lipitor, and Crestor are the most popular of these medications that reduce the risk of heart disease and stroke. Tens of millions of Americans take these medications, but a recent study that followed more than 150,000 women over the age of 50, with and without heart disease, found that those taking statin drugs had a 48 percent greater chance of developing type 2 diabetes. Doctors say that don’t know why statins increase diabetes, and that the research does not implicate any single brand. These findings seem to confirm prior smaller studies.

Now, I’m not saying that anyone should panic and stop taking their medication, since heart disease is one of the major complications of diabetes, but the risk is certainly something to consider and, ultimately, discuss with your doctor. Does the benefit outweigh the risk? It is going to depend on the patient.

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The FDA is advising that an additional concentration of liquid acetaminophen marketed for “infants” is now available. The new concentration, 160 mg/5 ml, will affect the amount of liquid given to an infant, and should be especially noted by consumers who re used to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

The Over-the-Counter (OTC) Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache.

Acetaminophen is marketed under brand names such as:

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The FDA Safety Information and Adverse Event Reporting Program has announced that the FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).

Gilenya is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults, and is used to reduce the frequency of flare-ups and delay physical disability.

The FDA believes – as do most neurologists – that Gilenya provides an important health benefit when used as directed, and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. The FDA recommends – obviously – that patients with MS not stop taking Gilenya without talking to their doctor.

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Last month brought changes to forty-eight (48) medical product labels (holding steady with 48 changes in October), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected: