Anavar (Oxandrolone): Medical History, FDA Withdrawal and Risks

Anavar is a brand name for oxandrolone, a steroid pill. It was a real medicine in the United States for decades. But in 2023 the FDA withdrew it, ruling that it was pulled from sale for reasons of safety or effectiveness.

Key facts: Oxandrolone is a steroid pill. It was approved as Oxandrin to help patients regain weight after surgery, infection or trauma. In 2023, the FDA withdrew its approval and the approval of all generic versions. It is a Schedule III controlled substance.

What oxandrolone is

Oxandrolone is a lab-made steroid based on testosterone. Like other steroid pills, it is 17α-alkylated. This chemical change lets it survive the liver when swallowed. The Endocrine Connections review notes that the same change makes steroid pills toxic to the liver.

Medical history

In the United States, it was sold as Oxandrin and as generic tablets. According to its FDA-approved label, it was used:

• to help patients regain weight after extensive surgery, chronic infections or severe trauma
• to offset the protein loss caused by long-term corticosteroid treatment
• to relieve the bone pain that often comes with osteoporosis

Why the FDA withdrew it

In June 2023, the FDA withdrew approval of Oxandrin and four generic versions, at the makers' request. In September 2023, the agency ruled that Oxandrin "was withdrawn from sale for reasons of safety or effectiveness." So the FDA will not approve new generic copies.

How it is misused

The review lists oxandrolone among the steroid pills that are still widely misused. In a Dutch study of 100 steroid users, 23% reported using it during a cycle.

Health risks

Its own label carried strong warnings, printed in capital letters. It warned that peliosis hepatis had been reported with anabolic steroids. In this condition, blood-filled cysts replace liver tissue. The cysts are often not found until the liver fails or bleeds, which can be deadly. The label also warned of liver tumors, some of them fatal cancers.

The FDA label for testosterone enanthate lists the serious problems reported in people who misuse steroids. They include heart attack, heart failure, stroke, liver damage and serious mental health problems such as major depression, mania, paranoia and aggression. Men can get shrunken testicles and become infertile. Women can get a deeper voice, more facial and body hair, male-pattern baldness and changes to their periods. In teens, bones can stop growing too early.

Large studies back this up. In a Danish study, men who tested positive for steroids had three times the death rate of similar men. A heart study found weaker heart muscle and more plaque in the arteries of long-term users.

Illicit products carry another risk. When Dutch researchers tested steroids used by 100 people, only about half held the drug named on the label, according to a review in Endocrine Connections. Some held no active drug at all.

Legal status

In the United States, oxandrolone is a Schedule III controlled substance. It is named in the federal list of anabolic steroids, 21 CFR 1308.13. It is a federal crime to have or sell it without a valid prescription.

In sport, it is banned at all times, in and out of competition, by the World Anti-Doping Agency.

Frequently asked questions

Is Anavar still available as a medicine?

No. The FDA withdrew approval of Oxandrin and its generic versions in 2023 and determined that it was withdrawn for reasons of safety or effectiveness.

Is Anavar a mild steroid?

Its label warned of blood-filled liver cysts and liver tumors, including fatal cancers. The FDA withdrew it for reasons of safety or effectiveness. "Mild" is not a description supported by its regulatory history.

Is Anavar legal?

No. Oxandrolone is a Schedule III controlled substance, and no approved product exists in the United States.

What was Anavar used for medically?

It was used to help patients regain weight after surgery, chronic infection or trauma, to offset protein loss from corticosteroids, and to relieve bone pain from osteoporosis.

Sources

• National Library of Medicine, DailyMed: Oxandrin (oxandrolone) label
• Federal Register: withdrawal of approval of Oxandrin and generic oxandrolone (June 2023)
• Federal Register: determination that Oxandrin was withdrawn for reasons of safety or effectiveness (September 2023)
• FDA-approved label: testosterone enanthate injection (Drug Abuse and Dependence)
• de Ronde W, Smit DL. Anabolic androgenic steroid abuse in young males. Endocr Connect. 2020
• Horwitz H, et al. Health consequences of androgenic anabolic steroid use. J Intern Med. 2019
• Baggish AL, et al. Cardiovascular toxicity of illicit anabolic-androgenic steroid use. Circulation. 2017
• U.S. Code of Federal Regulations: 21 CFR 1308.13, Schedule III
• World Anti-Doping Agency: Prohibited List