food and drug administration Archives

Editor’s note: This story was originally published Aug. 18, 1992, in The Dallas Morning News.

Graveside services for Ronald Woodroof, founder of the Dallas Buyer’s Club, an underground supplier of experimental AIDS medications, were held Monday at Restland Memorial Park in Dallas. Memorial services will be announced later.

Mr. Woodroof died of AIDS Saturday at his Dallas home. He was 42.

The Dallas native attended South Garland High School, then studied photography for a few years and later electronics at various Dallas-area schools.

He was a licensed electrical contractor until 1986, when he doctors told him that he had been infected with the AIDS virus and had six weeks to live, said his girlfriend, Deb McGregor of Fort Worth. She said he then decided against mainstream medicine and began searching for alternative therapies.

Mr. Woodroof began trying medications that had not been approved by the U.S. Food and Drug Administration because he had heard they were helping others live longer, said his mother, Billie Hughes Woodroof.

The FDA considers many of the experimental drugs unproven and even dangerous, although many people who use them feel they have little to lose and believe the drugs can extend their lives.

“When he set a goal, he met it,’ said Mrs. Woodroof. “When he first told me (that he had AIDS), I asked him, “What are you going to do about this?’ and he told me, “I’m not going to just sit down and die.’ “

A few months later, Mrs. Woodroof said, she lent her son a thousand dollars to go to Mexico to buy drugs.

She said he thought the drugs helped him, and he wanted to help others.

Mr. Woodroof made more trips, gathering more medications, and started the Dallas Buyer’s Club. It smuggles experimental AIDS medications that have not been approved by the FDA and sells them to about 4,000 people across the country.

Mr. Woodroof was responsible for finding medication sources, smuggling the drugs and finding laboratories to test them for purity. His search for medication often took him to Mexico, Japan and Denmark.

“He was a maverick, an inspiration and offered hope to thousands of people and worked hard for what he believed in,’ said Miss McGregor. “With his belief and self-will, he was able to live as long as he did.’

Other survivors include his daughter, Yvette Sweden of Odessa; a sister and brother-in-law, Sharon and Eugene Braden of Red Oak; and an uncle and aunt, Mr. and Mrs. Fred Schulz of Richardson.

Mr. Woodroof’s father, Garland Woodroof, died in 1983.

Memorials may be made to the AIDS Resource Center, the AIDS Foundation or V.N.A. Hospice.

FDA Approves Extended-Release Hydrocodone

The FDA has approved the first single-entity hydrocodone product (Zohydro ER, Zogenix) for management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved product containing the opioid analgesic hydrocodone not combined with another nonopioid analgesic such as acetaminophen, as well the first extended-release (ER) hydrocodone product.
   Zohydro ER is in the class of ER/long-acting (LA) opioid analgesics, which carry with them the risk for addiction, abuse and misuse, even at recommended doses. The FDA recently revised mandatory labeling for these agents. Labels now must state that these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or otherwise would be inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.
   The approved labeling for Zohydro ER makes it the first drug in its class to conform to the updated labeling requirements for all ER/LA opioid analgesics, which were announced by the FDA on Sept. 10, 2013.The new class labeling and stronger warnings more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications.
   Schedule II drugs can only be dispensed through a physician’s written prescription and no refills are allowed. There are also stringent recordkeeping, reporting and physical security requirements for Schedule II controlled substances.
The FDA is requiring postmarketing studies of Zohydro ER to assess the known serious risks associated with long-term opioid use. These studies also will be required for other ER/LA opioid analgesics.
   The safety of Zohydro ER is based on clinical studies of more than 1,100 individuals living with chronic pain. The efficacy of Zohydro ER is based on a clinical study that enrolled more than 500 patients with chronic low back pain who showed significant improvement with Zohydro ER compared with placebo.
   Zohydro ER will be part of the ER/LA opioid analgesics Risk Evaluation and Mitigation Strategy (REMS). Originally approved in 2012, the REMS for ER/LA opioid analgesics requires companies to make educational programs on how to safely prescribe ER/LA opioid analgesics available to health care professionals and to provide medication guides and patient counseling documents containing information on the safe use, storage and disposal of these agents.
   The most common side effects of Zohydro ER are constipation, nausea, drowsiness (somnolence), fatigue, headache, dizziness, dry mouth, vomiting and itching (pruritus).
     For more information, including full prescribing information, go to www.zogenix.com

Based on a press release from the FDA.