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 several tablets from the affected lots may exceed the weight requirement, essentially causing higher dosages of acetaminophen, resulting in consumers possibly 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 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 the 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 currently 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.

When codeine is ingested, the body converts it to morphine by a specific enzyme. Some people have DNA variations that make this enzyme more active, causing the codeine to be converted at a faster and more complete rate. These people are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can cause difficulty breathing, which can be fatal. For those children with this genetic ability, taking codeine may increase the risk of breathing problems and possible death.

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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 estrogen, and Prempro, a combination of Premarin and a progestin, which are both prescribed to combat the symptoms of menopause. The 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 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 recent 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 the strict construction of the 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 the 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 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 over 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 will 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 are 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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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 view the detailed summary which will identify the safety labeling section and revised subsection, and a brief summary of the new or modified safety information.

The following medications have been affected:

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Birth control drugs such as Yaz and Yasmin are under new scrutiny from safety regulators. These and other similar drugs, once heavily promoted as having fewer side effects and the ability to clear up acne, could be ordered by the Food and Drug Administration (FDA) to provide new warning labels, as research is now suggesting that newer birth control formulations are more likely to cause blood clots than older drugs. While the increased risk is slight, it is considered significant because blood clots can cause heart attacks, strokes, and blockages in the lungs or blood vessels, which can be fatal.
These popular drugs use a version of a female hormone that appears to reduce side effects that are found in older drugs, effects such as bloating and mood swings. But, the FDA is also reviewing research on clot risks associated with Johnson & Johnson’s weekly Ortho Evra patch, which uses a different version of the female hormone progestin.
Millions of women have used these products since they introduced a decade ago, but recent studies comparing the medical histories of women taking the new drugs to older ones suggest a slightly higher risk of blood clots in the legs and lungs. While all hormone-based drugs increase the risk of clotting, the matter is further complicated in that clots can be caused by factors such as smoking, obesity, or family history.

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