Drug Injury Watch

Next Fosamax Jaw Injury Lawsuit Trial, Secrest v. Merck, Scheduled To Start In Early September 2011

Federal Court Judge Keenan Wants Two More Fosamax - ONJ Bellwether Cases To Go To Jury Verdict After This Trial

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  "Merck Wins Another Federal Bellwether Trial Regarding FOSAMAX(R) (alendronate sodium)"  (10/3/11, Merck Press Release)
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UPDATE:  On August 30, 2011 U.S. District Judge John Keenan dismissed plaintiff Linda Secrest's claims for failure to warn, breach of warranty, fraudulent concealment, and punitive damages, allowing only a design defect claim to stand for trial.

See: "Judge Again Trims Claims for Trial in Fosamax Suit", New York Law Journal (9/1/11)
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The federal court Fosamax MDL Secrest v. Merck trial will start on September 7, 2011; it had been scheduled to begin on March 14, 2011 but was postponed due to illness.

This Secrest case if one of the hundreds of federal court lawsuits that are combined in In Re Fosamax Products Liability Litigation, MDL 1789, U.S. District Court, Southern District of New York (Manhattan).

It is anticipated that this Secrest Fosamax trial, which concerns bisphosphonate-induced osteonecrosis of the jaw (ONJ) as the alleged drug injury, or side effect, will take several weeks and a jury verdict can be expected in late September or early October 2011. 

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On February 4, 2011 Judge John F. Keenan, presiding over the federal court Fosamax multi-district litigation (MDL) issued an order calling for two additional "bellwether", or test, cases involving the jaw condition ONJ to go to trial after the Secrest verdict.

The first Fosamax trial in this federal court MDL, Boles v. Merck, started in August 2009.  It initially resulted in a mistrial, which was followed by a second trial of the Boles case that ended with an $8 million verdict for the plaintiff.  This jury verdict amount was later reduced to $1.5 million by Judge Keenan, who gave the plaintiff a choice to accept the lesser amount or have a new trial on the damages aspect of her case.  It is our understanding that Mrs. Boles and her attorneys decided on the new trial, which has not happened, yet.

We will monitor the Secrest Fosamax trial and report this next MDL jury verdict as soon as it becomes available.

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Multaq: August 2011 Update: Another Liver Failure Case Report Article In Medical Journal

New Sanofi "Dear Doctor" Letter: Label Change Regarding Heart-Related Side Effects Coming Soon

(Posted by Tom Lamb at DrugInjuryWatch.com)

This August 2011 update on Multaq (dronedarone) covers both liver injury and cardiovascular side effects.

The medical journal Circulation: Arrhythmia and Electrophysiology published an article, "Acute Liver Failure Associated With Dronedarone", which described the case of a 70 year-old woman in Germany who developed a drug-induced liver injury associated with her Multaq use.  From the Introduction section of that article:

A 70-year-old woman was initially referred to a community hospital for progressive fatigue and hyperbilirubinemia for 2 weeks. Six months before admission, she was started on [Multaq(dronedarone0] for atrial fibrillation....  She did not smoke, drink alcohol, or use illicit drugs....

On the basis of the timing of jaundice in relation to dronedarone exposure and the absence of any other identifiable cause, she was diagnosed with dronedarone-induced acute liver failure. Liver function tests did not improve with high-dose steroid therapy. On the 9th day of admission, altered mental status and beginning of hepatic encephalopathy was noted.

She was therefore transferred to the university hospital for liver transplantation.

In January 2011 it was announced that Sanofi-Aventis was sending a "Dear Doctor" letter warning that Multaq had been associated with liver failure.

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Now, in August 2011 Sanofi sent another Multaq "Dear Doctor" letter; this one was about cardiovascular side effects. 

In more detail, the subject of this August letter was the PALLAS (Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) phase IIIb clinical trial and why it was terminated early by the drug company, now known as just Sanofi.

The cardiovascular side effects -- cardiovascular death, stroke, and cardiovascular hospitalization, primarily heart failure hospitalizations -- which resulted in the PALLAS study being discontinued first got the attention of drug safety regulators in July 2011.

We will continue to monitor the safety profile of Multaq, both the liver injury and the various heart-related problems, going forward.

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Reports Of Male Breast Cancer Associated With The Use Of Propecia And Proscar

Recent Label Change For These Drugs Made In Canada But Not In U.S., Yet

(Posted by Tom Lamb at DrugInjuryWatch.com)

On August 4, 2011 Health Canada issued this Information Update, "Finasteride (Propecia, Proscar): Potential rare risk of breast cancer in men", which let us know about a possible new drug safety issue.

As background, Propecia, which is a one-milligram dose of finasteride (the active ingredient), is used to treat male-pattern hair loss.  Proscar, a five-milligram finasteride pill, is prescribed for benign prostatic hyperplasia or BPH, which is a non-cancerous enlargement of the prostate.  Both Propecia and Proscar are made by the drug company Merck. Generic versions of both medications are also available in the U.S. and Canada.

From this Health Canada item we learned:

• Most of these reports of male breast cancer have been in association with the Proscar 5mg pill.
• Patients taking Proscar, Propecia, or any generic finasteride drug should report any changes in their breasts to their doctor. Changes might include breast enlargement, lumps, tenderness, pain or nipple discharge.
• The package insert, or label, for Propecia, Proscar, and several of the generic finasteride products has already been updated in Canada to include information on the potential risk of male breast cancer.  Similar label changes to the remaining generic drugs will follow in Canada.

This August 4, 2011 report from CBC News, "Male breast cancer alert for baldness drug", provided this additional bit of information:

Up to March 31, Health Canada received two reports of male breast cancer involving the five-milligram dose and no reports involving the one-milligram dose, the department said in an email.

As of August 12, 2011, however, there had been no announcement by the FDA or Merck about any label revision in the U.S. to add a warning about male breast cancer.

We will continue to monitor this emerging drug safety issue and, in particular, watch to see if there is a corresponding label change for Proscar and Propecia here in the U.S.

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Increased Risk Of Bladder Cancer Warning Added To Actos Label By Takeda Announced In August 2011

European Drug Regulator EMA Recommended New Actos Contra-Indications And Warnings In July 2011

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "European Medicines Agency clarifies opinion on pioglitazone and the risk of bladder cancer"  (10/21/11, EMA Press Release)

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On August 4, 2011 we learned that Takeda Pharmaceuticals America, Inc. had revised the prescribing information -- also called the package insert or label -- for its diabetes drug Actos (pioglitazone) and other anti-diabetic pioglitazone-containing medicines by means of this item, "FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines":

The U.S. Food and Drug Administration (FDA) is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. FDA previously communicated these labeling changes to the public on June 15, 2011.  [See:  "Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder"]....

A couple of weeks earlier, on July 21, 2011, the European Medicines Agency (EMA) had recommended that Takeda put new warnings on the Actos label about possible links to bladder cancer in Europe. 

As for the action taken by the drug company Takeda and the FDA here in the U.S., the Actos label revised in July 2011 after FDA approval adds this new part to Section 5, "WARNINGS AND PRECAUTIONS":

5.5 Urinary Bladder Tumors

Tumors were observed in the urinary bladder of male rats in the two-year carcinogenicity study [see Nonclinical Toxicology (13.1)]. In two 3-year trials in which ACTOS was compared to placebo or glyburide, there were 16/3656 (0.44%) reports of bladder cancer in patients taking ACTOS compared to 5/3679 (0.14%) in patients not taking ACTOS. After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were six (0.16%) cases on ACTOS and two (0.05%) cases on placebo.

A five-year interim report of an ongoing 10-year observational cohort study found a nonsignificant increase in the risk for bladder cancer in subjects ever exposed to ACTOS, compared to subjects never exposed to ACTOS (HR 1.2 [95% CI 0.9 – 1.5]). Compared to never exposure, a duration of ACTOS therapy longer than 12 months was associated with an increase in risk (HR 1.4 [95% CI 0.9 – 2.1]), which reached statistical significance after more than 24 months of ACTOS use (HR 1.4 [95% CI 1.03 – 2.0]). Interim results from this study suggested that taking ACTOS longer than 12 months increased the relative risk of developing bladder cancer in any given year by 40% which equates to an absolute increase of 3 cases in 10,000 (from approximately 7 in 10,000 [without ACTOS] to approximately 10 in 10,000 [with ACTOS]).

There are insufficient data to determine whether pioglitazone is a tumor promoter for urinary bladder tumors. Consequently, ACTOS should not be used in patients with active bladder cancer and the benefits of glycemic control versus unknown risks for cancer recurrence with ACTOS should be considered in patients with a prior history of bladder cancer.

For background about the association between Actos and bladder cancer we refer you to our earlier article, "Actos-Related Bladder Cancer: June 2011 Review Of Regulatory Actions And Safety Warnings", concerning this emerging drug safety issue.

We remind patients using Actos that the FDA advises you should not stop taking any prescription medication, including Actos, before talking to your doctor.

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