Generic, Brand-Name Heart Drugs Seem to Have Same Effect on Thyroid (HealthDay)

WEDNESDAY, July 13 (HealthDay News) -- For patients taking the heart rhythm drug amiodarone (Cordarone), generic versions of the drug do not cause more incidents of thyroid dysfunction than the brand-name medication, researchers report.

When it comes to thyroid disease, there is no difference between the two drugs, according to the report released online July 11 in CMAJ (Canadian Medical Association Journal).

Amiodarone, a drug used to control arrhythmia -- a type of irregular heartbeat -- is known to cause hypothroidism and hyperthyroidism. These conditions affect the body's metabolism by altering the amount of hormone produced by the thyroid gland. Not enough thyroid hormone causes the body to slow down, resulting in weight gain, thinning hair and muscle pain. On the flip side, too much thyroid hormone results in nervousness, weight loss, rapid heart rate and diarrhea.

In conducting the study, researchers compared 2,804 atrial fibrillation patients aged 66 or older taking brand-name amiodarone (Cordarone) with 6,278 patients taking the generic form of the drug. The study revealed the two groups were equally affected by thyroid dysfunction.

"The incidence rate for thyroid dysfunction was estimated at 14.1 per 100 person-years, similar for both formulations," study author Dr. Louise Pilote, of the McGill University Health Center, and colleagues said in a journal news release. "The incidence rates for hypothyroidism and hyperthyroidism per 100 person-years were comparable between brand-name and generic formulations, with hypothyroidism occurring more commonly than hyperthyroidism."

The study authors pointed out that the findings should provide doctors and policy makers with critical information regarding the use of brand-name vs. generic drugs.

The researchers also noted that patients taking amidarone should be aware of the drug's possible side effects so they can recognize and report any symptoms.

More information

The U.S. National Library of Medicine provides more information on thyroid diseases.

Supreme Court rejects generic drug labeling suits (Reuters)

WASHINGTON (Reuters) – The Supreme Court ruled on Thursday that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects.

By a 5-4 vote, the justices gave a victory to Israel's Teva Pharmaceutical Industries Ltd, Mylan Inc's UDL Laboratories and Iceland-based Actavis Inc by overturning U.S. appeals court rulings that allowed such lawsuits.

The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration (FDA). Federal law requires generic drugs to have the same labels as their brand name equivalents.

Justice Clarence Thomas in the court's majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.

The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc's Wyeth unit and its antinausea drug Phenergan.

But in the generic drug cases, the justices reversed separate U.S. appeals court rulings that the lawsuits against the companies could go forward.

The high court agreed with the arguments of the generic drug makers that they had no choice but to use the same drug labels as the brand manufacturer.

Teva, Actavis and the Generic Pharmaceutical Association hailed the ruling.

COURT 'HIT NAIL ON THE HEAD'

Attorney Jay Lefkowitz, who represented Teva, said, "The Supreme Court hit the nail on the head today by making clear that federal law does not permit states to hold generic drug manufacturers liable for using the very warnings federal law required them to use."

Actavis CEO Doug Boothe called the ruling "an important and necessary step by the Supreme Court to clarify the proper interpretation of regulations governing pharmaceutical labeling."

Bob Billings, the trade group's executive director, said assessing liability would have placed "the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use but prevented by law from changing."

One case involved Julie Demahy, who sued Actavis and said it should have warned her of the risks of developing a neurological movement disorder from metoclopramide, a generic drug for heartburn, nausea and vomiting.

The drug's brand name equivalent is Reglan.

In another case, Gladys Mensing sued the three generic drug makers in federal court in Minnesota after allegedly developing the same disorder after taking generic versions of Reglan.

When the women first took the drug, the approved labeling said that "therapy longer than 12 weeks has not been evaluated and cannot be recommended."

That warning was changed in 2004 to say simply that therapy should not exceed 12 weeks and in 2009 the FDA ordered that specific warnings about the movement disorder be added to Reglan and metoclopramide.

The Obama administration supported the two women. It said the companies could have sought changes to the drug's label.

Generic drugs account for more than 70 percent of all prescriptions filled in the United States.

Liberal Justices Sonia Sotomayor, Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan dissented.

The Supreme Court cases are Pliva v. Mensing, No. 09-993, Actavis v. Mensing, No. 09-1039 and Actavis v. Demahy, No. 09-1501.

(Reporting by James Vicini, Editing by Gerald E. McCormick, Dave Zimmerman and Matthew Lewis)

No state lawsuits on generic drugs: US Supreme Court (AFP)

WASHINGTON (AFP) – The US Supreme Court narrowly ruled on Thursday that people may not sue generic drug makers under state laws if they believe a generic drug label failed to adequately warn of side effects.

The 5-4 ruling handed a victory to drug makers Teva Pharmaceutical Industries Ltd of Israel, the US company Mylan Inc and Actavis Inc of Iceland by blocking three consolidated lawsuits against them.

Plaintiffs had argued that they suffered a neurological disorder called tardive dyskinesia after taking the generic anti-heartburn drug metoclopramide (Reglan, Metozolv), which they said did not contain adequate warning labels.

The plaintiffs were prescribed the generic drug for Reglan in 2001 and 2002.

As early as 1985, evidence began to surface that long-term use of the drug could have serious side effects, but strong warnings were not added to the brand name drug labels by federal regulators until 2004 and 2009.

In 2009, the Food and Drug Administration ordered its strongest black box label warning that "metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible... treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases."

Even though the plaintiffs were prescribed the generic drugs before the stronger labels were federally ordered, they argued that the state should have done more to protect them by changing the generic drug labels because there was evidence to suggest long-term use could be harmful.

They sued the generic manufacturers under state tort laws that said the companies should have taken steps to protect consumers.

However the US high court said that federal laws require generic drugs to have the same labels as the brand names they copy, so courts could not demand they meet a different state standard at the same time.

"State tort law places a duty directly on all drug manufacturers to adequately and safely label their products," said the decision read by Justice Clarence Thomas.

"If the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law.

"Thus, it was impossible for the manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same."

The four liberal justices -- Sonia Sotomayor, Ruth Bader Ginsburg, Elena Kagan and Stephen Breyer -- dissented.

"As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug," said Sotomayor.

The decision affects 75 percent of all prescription drugs dispensed in the United States, the court said. When a generic is available to substitute for a brand name drug, the generic version is given out 90 percent of the time.