- Egypt rights center raided, 2 Mubaraks acquitted
- New Mexico Supreme Court rules same-sex marriage constitutional
- Blame Bush: 5 years later, that’s still the mantra, pollsters find
- Dutch prostitutes demand same retirement benefits as soccer stars
- John McCain to Harry Reid: I’ll ‘kick the crap’ out of you
- Dogs that talk: Researchers seek $10K for ‘No More Woof’ technology
- 1,000 firefighters called to battle stubborn Big Sur wildfire
- Black Friday brouhaha: Millions of Target shoppers hit by credit card theft
- Britain orders airplane to rescue citizens from violent South Sudan
- Mega Millions winner emerges as Georgia mom, in ‘disbelief’
Panel urges ADHD drug warning
Question of the Day
Ritalin and other stimulant drugs for attention-deficit (hyperactivity) disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisers said yesterday.
The Food and Drug Administration (FDA) advisory panel voted in favor of the “black box” warning after hearing about the deaths of 25 persons, including 19 children, who had taken the drugs. The vote was 8-7, with one abstention.
One committee member, Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be “inappropriate, unethical behavior” not to disclose that there was uncertainty about the safety of the drugs.
The FDA is not required to follow the recommendations of its advisory committees, but it typically does.
Doctors prescribe the drugs to about 2 million children and 1 million adults a month.
Drugs that would have to carry the warning labels are methylphenidates, which are sold as Ritalin, Concerta, Methylin and Metadate. The labels for Adderall and Adderall XR, both amphetamines, have included the warnings since 2004.
The Drug Safety and Risk Management advisory committee also recommended that the drugs include a medication guide for patients and parents. That vote was 15-0, with one abstention.
Adderall is made by Shire Pharmaceuticals; Ritalin by Novartis Pharmaceuticals Corp.; Concerta by Johnson & Johnson; Methylin by Mallinckrodt Pharmaceuticals; and Metadate by UCB. Various other companies make generic versions of Ritalin.
Novartis said Ritalin, approved by the FDA in 1955, is safe and effective. A company review of more than 50 years of records shows no apparent increase in cardiovascular problems associated with the drug’s use, said Novartis’ medical safety director, Dr. Todd Gruber.
He told the committee that the drug’s label advises caution in patients with certain pre-existing heart conditions.
The FDA had asked the advisers to consider ways of studying the drugs because agency data suggested that the drugs were linked to an increased risk of sudden death and serious cardiovascular problems, including heart attacks.
The committee, however, quickly began debating whether it should consider new warnings for the drugs rather than the need for more studies.
Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at the Cleveland Clinic, told fellow committee members that they should recommended the black box warning.
By Andrew P. Napolitano
Fourth Amendment says Obama is not at liberty to collect metadata
- Calling sentence disparities unfair, Obama pardons 8 crack offenders
- Homeland Security helps smuggle illegal immigrant children into the U.S.
- Gov't wasted $30 billion on 'pillownauts,' crystal goblets -- buying human urine!
- Bill Gates: The Secret Santa disguised as a 'friendly fellow' on Reddit
- Armed response, not restrictive gun laws, brought swift end to school shooting
- Obamacare 'pajamas boy' gets roundly mocked
- BOLTON: Nero in the White House
- Duck Dynasty Phil Robertson suspended indefinitely for gay quip
- U.S. Army mulls wiping out memory of Robert E. Lee, 'Stonewall' Jackson
- Outrage over Phil Robertson suspension, 'malignant' political correctness
Independent voices from the The Washington Times Communities
The world impacts us. What happens in our towns, cities, states, country and on this planet makes a difference to us.
Brazen, leading-edge, “call it like it is” columns and reporting from Ohio native, radio host and writer, Sara Marie Brenner.
Crystal Wright is a black conservative woman living in Washington, D.C.
Wall Street news for retail investors who want to know what's going on.
Top 10 handguns in the U.S.
Extraordinary day at Redskins Park
White House pets gone wild!
Let it snow