FAQ: Why Was Depo Provera Banned in 1978?

The FDA Decision: Why Was Depo Provera Banned?

The FDA’s repeated rejection of Depo Provera for contraceptive use between 1967 and 1983 represents one of the most contentious regulatory battles in pharmaceutical history.

Despite being available for non-contraceptive purposes in the United States since 1959 and approved as a contraceptive in numerous other countries by the 1970s, the FDA maintained its prohibition on Depo Provera shot use for birth control based on alarming safety data.

This decade-spanning prohibition occurred while the drug’s manufacturer, Upjohn Company, simultaneously conducted widespread testing on vulnerable populations internationally, creating a troubling dichotomy where Depo Provera patients in developing nations were exposed to a drug deemed too dangerous for American women by U.S. regulators according to findings from studies published in the Journal of the American Medical Association.

How Depo Provera Caused Cancer in Laboratory Animals

The pivotal evidence against Depo Provera came from laboratory studies where animals exposed to medroxyprogesterone acetate developed significant cancer risks.

When the drug was tested in 1973, FDA scientists noted that beagles receiving the drug demonstrated escalated risks of breast cancer, though they initially argued that the drug had such a “small patient population, that limited clinical trials with informed patient consent” would be permitted.

This hesitant stance hardened following more comprehensive results from the seven-year beagle study completed in 1975, which proved decisive in the 1978 rejection.

Additional animal studies revealed serious health risks associated with Depo Provera:

• A 10-year study involving 52 rhesus monkeys initiated in 1968 showed that monkeys receiving high doses of Depo Provera developed endometrial cancer.
• These animal studies provided the scientific foundation for the FDA’s rejection decisions.
• Critics of the ban argued that beagles were poor models for human carcinogenicity studies due to their naturally high risk of mammary tumors.
• This data, combined with concerns about potential birth defects from fetal exposure and ethical issues surrounding clinical trials, kept the drug off the American contraceptive market until 1992.

The eventual approval of Depo Provera in 1992 and the later development of Depo SubQ Provera (approved in 2004) followed decades of international use and further research that reconsidered the cancer risk data.

Safety concerns never fully dissipated, with the FDA requiring black box warnings about bone density loss for both formulations and recommendations against long-term use exceeding two years.

These persistent safety questions have fueled ongoing debate about whether regulators struck the appropriate balance between making effective contraceptive options available while adequately protecting Depo Provera patients from potential long-term health risks.

Failed Clinical Trials and Emerging Safety Concerns

The first application for Depo Provera’s approval as a contraceptive came in 1967, but by 1974, the FDA issued its initial rejection based on preliminary safety data.

This decision was solidified in 1978 following concerning results from a seven-year study involving 36 beagle dogs, where two animals developed malignant breast tumors after receiving the hormone injection.

The beagle studies were particularly significant because the breed had become the FDA’s standard animal model for testing drug safety following the thalidomide tragedy, making these findings difficult to dismiss.

The regulatory saga continued with a rare “Public Board of Inquiry” convened by the FDA in 1983, where gender and power dynamics played central roles in negotiations between scientists, physicians, patients, and advocacy groups.

Throughout this process, the National Women’s Health Network emerged as a formidable opponent to approval, raising pointed questions about both the drug’s safety profile and the ethics of testing practices that disproportionately targeted vulnerable populations.

Their objections highlighted fundamental concerns about informed consent and coercion in the clinical trials, particularly those conducted on poor women, rural women, and third-world women who often lacked access to alternative contraceptive options or complete information about potential risks.

If you or a loved one has suffered health problems after receiving Depo Provera injections, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify for the Depo Provera Lawsuit today.

Depo Provera Linked to Increased Health Risks for Women

The controversial history of Depo Provera reveals a pharmaceutical intervention that received multiple FDA rejections between 1967 and 1992 before finally gaining approval as a contraceptive option in the United States.

Initially approved only for cancer treatment, the injectable containing medroxyprogesterone acetate faced significant regulatory hurdles due to safety concerns, including cancer risks in animal studies, which delayed its contraceptive approval for 25 years despite widespread international use.

Recent scientific research published by the National Library of Medicine has uncovered additional serious health concerns for Depo Provera users.

Why Was Depo Provera Banned Then Later Approved?

The initial FDA rejections of Depo Provera stemmed from alarming laboratory studies showing significant cancer risks in animals exposed to the drug.

When Upjohn Company first sought FDA approval in 1967 for the drug Depo Provera as a contraceptive, researchers discovered beagles receiving the drug developed an elevated risk of breast cancer, leading to FDA rejections in 1978 and 1983 despite its availability in other countries.

Many experts disagreed with the FDA rulings, arguing that the evidence of increased breast cancer came from studies conducted on beagle dogs, not humans, and that the FDA’s own advisory committees had recommended approval.

Legal developments in the Depo Provera regulation include, but are not limited to:

• Initial FDA approval for cancer treatment only in 1978, restricting contraceptive use
• Clinical trials conducted internationally before U.S. approval, raising ethical concerns about testing on vulnerable populations
• Approval was finally granted in 1992 despite objections from women’s health organizations
• Subsequent safety warnings were added, including a 2004 black box warning about bone density loss
• Recommended usage limited to no more than two years unless other contraceptive methods are inadequate

Birth Control Shot Linked to Increased Brain Tumor Risk

The 2024 emergence of research linking the birth control shot to brain tumors has created new concerns about the long-term safety of this contraceptive method.

A March 2024 study published in the BMJ found that prolonged use of Depo Provera for more than one year was associated with a 5.6-fold increased risk of intracranial meningioma requiring surgery.

The relationship between hormonal contraceptives and brain tumors continues to undergo scientific scrutiny as researchers seek to understand the mechanisms behind these findings.

The implications extend beyond contraception since the hormone is also used for treating endometriosis and other conditions, highlighting the broader relevance of these safety concerns across multiple treatment contexts where synthetic progestins are employed.

How Can A Depo Provera Attorney from TruLaw Help You?

Our Depo Provera attorney at TruLaw is dedicated to supporting clients through the process of filing a Depo Provera lawsuit.

With extensive experience in dangerous drugs cases, Jessica Paluch-Hoerman and our partner law firms work with litigation leaders and medical experts to prove how Depo Provera injections caused you harm.

TruLaw focuses on securing compensation for medical expenses, meningioma treatment costs, pain and suffering, and other damages resulting from your Depo Provera-related meningioma.

We understand the physical and emotional toll that Depo Provera complications have on your life and provide the personalized guidance you need when seeking justice.

Meet the Lead Depo Provera Attorney at TruLaw

Meet our lead Depo Provera attorney:

• Jessica Paluch-Hoerman: As founder and managing attorney of TruLaw, Jessica brings her experience in product liability and personal injury to her client-centered approach by prioritizing open communication and personalized attention with her clients. Through TruLaw and partner law firms, Jessica has helped collect over $3 billion on behalf of injured individuals across all 50 states through verdicts and negotiated settlements.

How much does hiring a Depo Provera lawyer from TruLaw cost?

At TruLaw, we believe financial concerns should never stand in the way of justice.

That’s why we operate on a contingency fee basis—with this approach, you only pay legal fees after you’ve been awarded compensation for your injuries.

If you or a loved one developed meningioma after receiving Depo Provera injections, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a Depo Provera lawsuit today.

TruLaw: Accepting Clients for the Depo Provera Lawsuit

Depo Provera lawsuits are being filed by individuals across the country who developed meningioma and other significant health complications after receiving the contraceptive injection.

TruLaw is currently accepting clients for the Depo Provera lawsuit.

A few reasons to choose Depo Provera lawsuit lawyers at TruLaw for your case include:

• If We Don’t Win, You Don’t Pay: The attorneys handling Depo Provera lawsuits at TruLaw and our partner firms operate on a contingency fee basis, meaning we only get paid if you win.
• Expertise: We have decades of experience handling dangerous drugs cases similar to the Depo Provera lawsuits.
• Successful Track Record: TruLaw and our partner law firms have helped our clients recover billions of dollars in compensation through verdicts and negotiated settlements.

If you or a loved one has experienced health problems after receiving Depo Provera injections, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify to join others in filing a Depo Provera lawsuit today.