History of Depo Provera | Complete Timeline 1954 to Present

Initial FDA Approval Depo Provera (1960s-1992)

The FDA approval journey of medroxyprogesterone acetate DMPA, marketed under the brand name Depo Provera, represents one of the most contentious medical regulatory battles in U.S. history, spanning from the 1960s to 1992.

While initially approved by the FDA in 1959 for treating conditions like irregular uterine bleeding, its path to contraceptive approval involved three major FDA rejections in 1974, 1978, and 1983, with concerns ranging from potential cancer risks to ethical questions about clinical trials conducted primarily on vulnerable populations in developing countries without proper informed consent.

Controversial Clinical Trials and Initial FDA Rejections

Testing of Depo Provera as a contraceptive began in the mid-1960s when Upjohn Company initiated human clinical trials that quickly drew criticism for targeting vulnerable populations, including low-income women, women in developing countries, and those with limited access to alternative family planning methods.

These trials raised serious ethical concerns as researchers often failed to obtain proper informed consent, with reports of inadequate record-keeping, lost patient files, and failure to track serious side effects, making meaningful follow-up studies nearly impossible.

The three major rejections reflecting the FDA’s safety concerns include:

• 1974 Rejection: Cited potential cancer risks and questions about long-term safety
• 1978 Rejection: Followed disturbing results from a beagle study where animals developed malignant tumors
• 1983 Rejection: Came after an unusual “Public Board of Inquiry” where gender and power dynamics played central roles

Throughout this process, advocacy groups like the National Women’s Health Network strongly opposed approval based on concerns about study objectivity and potential health impacts on women.

FDA Approval of Depo Provera as a Contraceptive Injection

Despite persistent opposition from women’s health advocates, the FDA finally approved Depo Provera as a contraceptive in October 1992, expanding the range of available hormonal contraceptives in the United States while acknowledging potential side effects like bone mineral density loss and menstrual irregularities.

The approval came after the World Health Organization presented a review to the FDA involving the drug’s use in four developing countries, though critics noted the WHO had already been distributing the drug internationally for years, raising questions about conflicts of interest in the approval process.

The Depo Provera story didn’t end with the 1992 approval, as subsequent innovations led to the development and 2004 FDA approval of Depo subQ Provera, a formulation using a smaller needle and lower dose (104 mg compared to 150 mg) administered subcutaneously rather than intramuscularly.

While these injections remain among the most effective reversible contraceptive options, with failure rates of only about 0.3% when administered on schedule, ongoing concerns about long-term health impacts have led to recommendations limiting continuous use to no more than two years unless other contraceptive methods are inadequate.

Global Expansion of Depo Provera Birth Control (1990s)

The 1990s marked a significant period in the global adoption of Depo Provera as a contraceptive option.

After decades of controversy, Depo-medroxyprogesterone acetate (DMPA) gained wider acceptance internationally.

Women in various countries turned to this quarterly injection as it eliminated the need to track their menstrual cycle, offering convenience that daily contraceptive pills couldn’t match.

Healthcare providers promoted it particularly in regions with limited healthcare infrastructure, as its long-lasting effects required minimal follow-up care.

International Use of DMPA Injection Before US Approval

While the United States delayed FDA approval until 1992, many developing nations had already implemented widespread Depo Provera programs.

International aid organizations distributed the injection across countries in Africa, Asia, and Latin America throughout the 1980s.

Some women’s health advocates raised concerns about potential weight gain associated with the injection, especially in regions with food insecurity.

Nonetheless, the World Health Organization backed the method for its effectiveness and practicality in areas where consistent access to healthcare was limited.

Marketing Strategies for Depo Provera Contraceptive Options

When Upjohn (later acquired by Pfizer) finally received approval to market Depo Provera in the United States, they employed carefully crafted promotional campaigns.

Their materials positioned the product as distinct from hormone replacement therapy, emphasizing its contraceptive benefits rather than any effect on menopausal symptoms.

Advertisements targeted women seeking long-term birth control without daily maintenance, showcasing freedom and convenience.

Healthcare providers received extensive educational materials highlighting patient satisfaction rates while downplaying potential side effects.

Health Concerns and Increased Risk Discoveries (2000s)

The early 2000s marked a turning point in understanding Depo Provera’s long-term health implications.

In 2004, the U.S. Food and Drug Administration (FDA) added a “black box” warning to DMPA labeling about the potential loss of bone mineral density (BMD) that changed how the medication was prescribed.

This type of warning is the strongest the FDA can issue.

Black Box Warnings About Bone Density and Other Side Effects

The FDA-mandated black box warning was a watershed moment for Depo Provera users.

The black box warning stated that prolonged use of the drug “may result in significant loss of bone density” and that “the loss is greater the longer the drug is used.”

This led to the FDA recommendation that Depo Provera not be used for longer than two years unless other birth control methods were inadequate.

Healthcare organizations had to adjust their practices, advising women on the medication to take calcium supplements and engage in weight-bearing exercise to mitigate potential bone loss.

The warning particularly highlighted concerns for young women who were still developing peak bone mass.

Increasing Litigation and Patient Awareness (2020s)

The medical evidence connecting Depo Provera to serious health conditions has led to legal consequences for its manufacturer.

Recent studies published in 2024 have prompted lawsuits against Pfizer, with plaintiffs alleging that the company failed to adequately warn users about the increased risk of cerebral meningiomas associated with prolonged Depo-Provera use.

Studies Linking Depo Provera Injections to Brain Tumors

More recently, further health concerns have emerged regarding Depo Provera use.

A national case-control study published in 2024 found that prolonged use of medroxyprogesterone acetate was associated with an increased risk of intracranial meningioma, with injectable forms showing a 5.55-fold increased risk compared to non-users.

These findings built upon earlier evidence connecting synthetic progestins to tumor growth.

While meningiomas are typically benign, their location near the brain can cause serious health problems, including headaches, vision changes, and other neurological symptoms.

The study showed risk was highest among women who had used the injectable form for more than one year.

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, pain and suffering, and other damages resulting from your Depo Provera injuries.

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 experienced bone density loss, osteoporosis, fractures, or other health complications 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 women nationwide after discovering the increased risk of developing brain tumors and other health complications after receiving the contraceptive injection for a prolonged period.

TruLaw is currently accepting clients for the Depo Provera lawsuit.

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

• If We Don’t Win, You Don’t Pay: The Depo Provera lawyers 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 lawsuit.
• 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 suffered bone density loss, fractures, or other 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.