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Pharma giant Merck & Co. is winding down litigation related to its popular arthritis drug Vioxx.  Bloomberg reports the company paid out claims from a $4.85 billion settlement fund to the families of 3,468 Vioxx users who died of heart attacks or strokes.  Vioxx was pulled from the market in 2004 after a study linked it to an increased risk of cardiovascular events.

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California Medicaid patients may be taking dangerous amounts of acetaminophen, according to a new UC Davis study. Acetaminophen is safe at four grams a day or less but it is prescribed to some patients in much greater quantities, according to the study published in Annals of Pharmacotherapy.

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The makers of NuvaRing, a birth control device, have been sued by a Louisiana woman who alleges that using the product lead to the formation of a blood clot in one of her veins. Organon Pharmaceuticals USA, Organon International and Schering-Plough Corp. were named in the suit, which was filed in New Orleans federal court.

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Blood pressure drugs have been under a lot of pressure lately, as we’ve blogged here and here.

In the latest development, the Food and Drug Administration (FDA) today announced it will review the class of medications known as angiotensin receptor blockers (ARBs) after a recent study suggested they may be linked to a small increased risk of cancer. The agency stressed that it has not concluded that ARBs increase cancer risks and that its review is ongoing.

ARBs are prescribed for patients with high blood pressure and other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. ARBs are also sold in combination with other medications.

The FDA said it will review the available data and evaluate better ways to assess a possible link between ARBs and cancer.

As always, do not change medications without consulting with your doctor first.

GlaxoSmithKline’s embattled Avandia won a reprieve today after a Food and Drug Administration (FDA) advisory panel voted to keep the diabetes pill on the market despite evidence that it increases the risk of heart attacks.

The 33-member panel voted 20-12 against banning the sale of Avandia although those who wanted to keep the drug on the market also favored adding new warning labels and restricting its use, reports the Associated Press.

A majority of the panel also ruled that Avandia did not appear more likely to cause death than other diabetes drugs, according to the AP. The vote surprised observers since earlier the panel found sufficient evidence that Avandia may increase the risk of heart attack and stroke compared to other diabetes medications.

The FDA will now review the panel’s recommendations and make the final call on Avandia’s fate.

Avandia (rosiglitazone) is used to control blood sugar in people with type 2 diabetes, the most common form of the disease. Its safety  has come under increasing attack since February, when the FDA and the US Senate released reports critical of the cardiac risks associated with it.  But the drug has been embattled since 2007, when a study by the Cleveland Clinic linked it to an increased risk of heart attack. The FDA issued a safety alert for Avandia that same year.

GSK has defended Avandia even as it has recently settled hundreds of lawsuits brought by patients alleging the drug caused heart attacks and other health issues.

If you believe that you or a loved one has been harmed by Avandia, Sokolove Law may be able to help.

The Food and Drug Administration (FDA) will now require the rheumatoid arthritis drug Arava (leflunomide) to include information on severe liver injury as part of its black box warning.

Arava already carries a boxed warning that its use is contraindicated in pregnant women and women of child-bearing age who are not using a reliable contraception method.

The FDA said its decision was based on a review of 49 adverse event reports — including 14 cases of fatal liver failure — between August 2002 and May 2009. The greatest risk for liver injury occurred in patients with pre-existing liver disease and in those who took Arava while taking other drugs known to cause liver injury, according to the FDA.

In its safety advisory, the FDA said Arava patients should have their liver enzymes monitored at least monthly for three months after starting the drug and at least quarterly afterwards.  Treatment should be stopped if the patient’s ALT rises to greater than two times normal while the patient on leflunomide. A cholestryamine washout should be used to remove the drug from the body.

Patients taking Arava who experience itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools should contact their doctor immediately.

Prescription blood thinner Coumadin (warfarin) is being recalled by Bristol-Myers Squibb Co. since the level of its active ingredient, isopropanol, may shift over time, according to the Associated Press.

No side effects have been reported and the recall is being done as a precaution. The AP reports the recall involves more than 144,000 1-miligram tablets of Coumadin that were distributed in blister packs with expiration dates from June 2011 to November 2012.

Coumadin is used after surgery to avoid blood clots. However, Bristol-Myers told the AP that too much isopropanol could increase a patient’s chance of bleeding; too little could increase a patient’s risk of clots.

Should Avandia be pulled from the market?

That’s the key question the Food and Drug Administration (FDA) must decide as it meets this week to ponder the fate of GlaxoSmithKline’s (GSK) controversial diabetes drug, which some studies have linked to increased risk of heart attack, stroke, and death.

Two recent news reports have made Avandia’s position even tougher on the eve of this critical meeting at which an expert panel will assess the drug’s safety and recommend whether it should remain on the market.

First, The New York Times reported that an FDA reviewer last week issued a devastating critique of the clinical study used by GSK to refute safety claims lodged against Avandia.  The reviewer found that the so-called Record study failed to count at least twelve instances in which patients who used Avandia may have suffered cardiovascular problems, reports the Times. GSK stands by the study’s results, which will be part of the data reviewed by the FDA panel this week.

Meanwhile, Bloomberg News reported that a former FDA official has alleged that GSK did not share with federal regulators a study showing that Avandia might pose a greater heart attack risk than some other diabetes drugs. The allegation was made by Dr. Rosemary Johann-Liang in a deposition she gave in a lawsuit filed against GSK, according to Bloomberg. GSK took issue with Johann-Liang’s account and told the news service that no studies have proven that Avandia is dangerous.

Avandia (rosiglitazone) has come under increasing scrutiny since February, when the FDA and the US Senate released reports critical of cardiac risks associated with it. But the drug has been embattled since 2007, when a study by the Cleveland Clinic linked it to an increased risk of heart attack. The FDA issued a safety alert for Avandia that same year.

GSK has defended Avandia even as it has recently settled hundreds of lawsuits brought by patients alleging the drug caused heart attacks and other health issues.

As always, do not change any medication without first consulting your doctor.

Johnson & Johnson faces five potential class-action suits from consumers who have sued the drugmaker in federal court over its plan to offer refund coupons for its recalled children’s cold and allergy medicines, according to Bloomberg News.

The suits, which accuse the company of racketeering and fraud, claim the coupons are “worthless” because the medicines are not currently being made.  Also, consumers who have tossed the drugs and don’t have a receipt wouldn’t be eligible to receive the coupons. Bloomberg reports the suits instead seek a cash refund.

In April, J&J’s McNeil Consumer Care unit issued a product recall for more than 40 kinds of children’s cold and allergy drugs (including liquid Tylenol and Benadryl) for problems with quality and potency, according to Bloomberg.

New European studies suggest that pregnant women who take the anti-epilepsy drug Depakote may face more than double the risk of major birth defects in their children when compared to those who used other anti-epileptic medications, according to a MedScape report (subscription required).

Results from the two studies – the UK Epilepsy and Pregnancy Register and the European and International Registry of Antiepileptic Drugs in Pregnancy (EURAP) – were presented at the 9th European Congress on Epileptology last week.

We’ve blogged here and here about the risk of major birth defects associated with taking Depakote (divalproex sodium) and other valproate medications during pregnancy. Birth defects linked to Depakote include: spina bifida (a neural tube defect), abnormal skull development (craniosynostosis), cleft palate, and holes in the heart (atrial septal defect).

In the UK study, the data found that women who used Depakote and other valproate drugs in pregnancy had double the risk of major congenital malformations (6 percent) when compared to pregnant women who took the anti-epileptics carbamazepine or lamotrigine, reports MedScape.

Findings from the EURAP study are still preliminary. However, Medscape writes the study found that pregnant women who took Depakote faced a 9.3 percent risk of a major birth defect in their newborns versus those who used lamotrigine (2.9 percent) or carbamazepine (5.7 percent).