The FDA's Newest Spin on Darvon
Here’s how Merriam Webster’s Learning Dictionary defines the cliché, spin your wheels: to stay in the same condition or position without making progress. Here’s how I define spin your wheels: Food and Drug Administration. I’ve been blogging about the FDA’s incompetence for quite awhile now. Here’s just one more case in point – the prescription painkiller Darvon and its sister drug, Darvocet. Darvon has been on the market since 1957, and was developed by Eli Lilly & Co. Darvocet is a a combination of Darvon’s active ingredient, propooxyphene and acetaminophen, the active ingredient in Tylenol. Both drugs are now marketed by generic drug manufacturers.
Decades after the advocacy group Public Citizen began questioning the safety and effectiveness of these drugs, the FDA finally decided to take a closer look. Public Citizen’s research implicates propoxyphene in 5.6% drug-related deaths and 2,110 accidental deaths from 1981 to 1999. The FDA also cited reports of suicides, overdoses and heart attacks from the use of propoxyphene.
So last week, an FDA panel of advisors voted 14-to-12 that the drug's benefits didn't outweigh its risks. They’re also asking for the removal of Darvon and Darvocet from the U.S. market. Wow, I wonder how they came to the conclusion that these drugs may not be safe? But wait, there’s more! The final decision is up to the FDA, which doesn’t always take its panel’s recommendations, especially with such a close vote.
Those wheels just keep spinning faster and faster. For more information, read the January 31, 2009 Wall Street Journal article below:
Panel Urges Darvon Ban
WASHINGTON -- A Food and Drug Administration panel recommended banning the painkiller Darvon and a related drug, following a decades-long effort by critics who charged that the drugs' users often intentionally or unintentionally overdose on them.
Darvon has been on the market since 1957, and Saturday marks the 30th anniversary of the first congressional hearing on its safety. Nonethless, it still enjoys wide use in treating mild to moderate pain. More than 20 million prescriptions were written in 2007 for products containing propoxyphene, the active ingredient in Darvon, according to the FDA.
The panel voted 14-to-12 that the drug's benefits didn't outweigh its risks, and called for removal from the U.S. market. The final decision is up to the FDA, which usually adopts panel recommendations but not always, especially when the vote is so close.
Darvon's defenders argue it is safe and effective when used as directed. The label warns against taking it in combination with alcohol or certain other drugs.
Darvon was developed by Eli Lilly & Co., which later combined propoxyphene with acetaminophen, the active ingredient in Tylenol, and sold that pill as Darvocet. Today the drugs are marketed by generic-drug makers.
Sidney Wolfe, a doctor at the advocacy group Public Citizen, has been fighting Darvon since the late 1970s, and triggered Friday's panel meeting with a petition and a lawsuit that sought to force the FDA to ban the drug.
In its petition, Public Citizen cited data from the Drug Abuse Warning Network implicating propoxyphene in 5.6% of drug-related deaths from 1981 to 1999. Public Citizen also said the network reported 2,110 accidental deaths related to propoxyphene over the same period.
The FDA also cited reports of serious events such as suicides, intentional and unintentional overdoses and heart attacks. But the agency's analysts said the evidence wasn't conclusive enough to ban Darvon.
In an interview about Darvon before Friday's meeting, Dr. Wolfe said, "Claims of its efficacy have been seriously undercut by the FDA's own analysis." He noted that the agency said Darvon "possesses weak analgesic effects."
In his presentation Friday, Dr. Wolfe presented updated data showing 503 deaths in 2007 in which propoxyphene was listed as a contributing factor. "All drugs have risks," Dr. Wolfe said. "If they don't have benefits they need to come off the market."
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com and Alicia Mundy at alicia.mundy@wsj.com
©2009 Angel Reyes
www.ReyesLaw.com
Subscribe to this feed