ADD Drug Strattera, Already Under FDA Scrutiny, Raising New Safety Concerns in UK as Well

Although pharmaceutical giant Eli Lilly (Lilly) continues to maintain that its attention deficit drug, <"">Strattera, is safe, the company’s actions as well as those of the FDA would seem to indicate quite the opposite.

On September 28, 2005 for example, Lilly declared it was adding a black-box warning to Strattera. That warning advises that the drug may increase suicidal thoughts among youths.

FDA officials said Eli Lilly must also create a medication guide for patients and healthcare providers pertaining to the new black box warning. Black box warnings are the most prominent and serious of medication warnings.

The FDA said Lilly submitted results from a Strattera clinical trial of 1,357 youths taking the medication that found five of them had increased suicidal thoughts, while none of 851 youths taking a placebo showed such changes. Lilly said one youth attempted suicide during its Strattera trials, but that researchers saw no signs of increased suicidal thoughts among adults.

Strattera has also been linked to liver problems. In 2004, Lilly warned doctors to stop prescribing Strattera in patients with jaundice or who show signs of liver damage.

Lilly warned that Strattera can cause severe drug related liver injury that can progress to acute liver failure resulting in death or the need for a liver transplant. In December 2004 the FDA updated Strattera’s label to include the serious liver side effects.

In December of last year, Dr. Thomas Laughren, director of the FDA’s division of psychiatry products, said the federal government requested Lilly to assess 13 clinical trials conducted on children to measure a suicide risk.

“The risk for any individual patient taking this drug is quite low, but from a public health standpoint, four (case) per thousand is a fairly big signal, given there are tens of thousands of patients taking this drug,” Laughren said.

In June 2005, the FDA announced it will be investigating all attention deficit hyperactivity disorder drugs including Strattera, Ritalin, Concerta, and <"">Adderall in response to reports of serious psychiatric side effects in patients taking <"">Concerta and Ritalin. Some <"">ADHD drugs are also associated with cardiovascular side effects.

In what many experts are viewing as an unusual turn of events, an FDA advisory panel, in January of this year, voted (8-7-1) to recommend that the agency order the inclusion of the most serious “black box” warning on all stimulant ADHD medications due to evidence of a potential risk of heart attacks, strokes, and sudden death. The drugs include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin, and Metadate.

The panel also voted 15-0-1 to recommend that the FDA require that the drugs include a medication guide for patients and parents.

This new controversy was prompted by data that showed that widely prescribed ADHD drugs like Ritalin may be lined to as many as 25 deaths that occurred between 1999 and 2003. Of these deaths, 19 involved children.

In addition, the FDA was advised of 54 cases involving serious cardiovascular problems like heart attacks, strokes, hypertension, heart palpitations and arrhythmias in both adults and children taking these medications.

There is also the open issue of another 26 deaths between 1969 and 2003 in medicated ADHD patients involving suicide, intentional overdose, drowning, heat stroke, and underlying diseases.

The panel’s vote also caught the FDA off guard because the committee was convened to advise the agency on how to design studies to assess possible risks associated with stimulant ADHD medications. (Adderall is the only non-stimulant ADD drug).

During the meeting, however, talk soon turned to the over-prescribing of these drugs and the public as well as many doctors were unaware of these serious potential risks. The panel then agreed to consider the enhanced-warning issue that was outside of its planned agenda.

The FDA has attempted to back off from the unexpected action by the panel by issuing a statement that it would be reluctant to require a black box warning based on a “theoretical risk.”

Such warnings could unreasonably deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA’s Center for Drug Evaluation and Research. He stated: “The absence of bona fide problems in your hand pushes against the box. We will also, frankly, worry about the possibility that overstatement can do active harm.”

Thus, Temple indicated the full FDA would wait for the recommendation of a pediatric advisory committee scheduled for March before reaching any decision with respect to new warnings. That panel, which is made up of pediatricians and psychiatrists, is considered more likely to look favorably on the benefits of ADHD drug treatment as outweighing the potential risks.

Now comes word that Strattera is faring no better in the UK in light of these safety concerns well as the possibility that the drug is also associated with seizures and a potentially dangerous lengthening of the interval between heartbeats.

According to, the Tacoma (Washington) News Tribune, and Reuters, the “warnings are based on an internal report by the British Medicine and Healthcare Products Regulatory Agency…The report, which has not been made readily available to the public, was obtained by The News Tribune after a Swedish court ordered it released in that country.

“Though the number of seizures and heart-rhythm problems is small, the British agency said problems could be under-reported, and it warned doctors and consumers that the drug should be used with caution in people prone to such problems.

“In particular, they warned about potential heart problems when Strattera is combined with antidepressants like Paxil and Prozac.”

Although British authorities still believe the drug’s benefits outweigh its risks, they are updating the drug’s label in that country to warn of the possible problems. Presently, no warnings regarding the seizure risk are contained in the U.S. labeling. The heart problem risk, however, was inserted in the 25-page U.S. label in January at the request of the FDA.

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