Healthy Skepticism Library item: 214

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Publication type: news

Mandal , V .
Women ponder class-action suit
The Leader-Post 2004 Feb 26

Full text:

Debilitating side-effects from the contraceptive Depo-Provera have hundreds of Canadian women considering a class-action lawsuit against the maker Pharmacia Upjohn.

About 10,000 women from Canada and the U.S. have posted their stories on several Web sites. Three separate U.S. lawsuits have been launched.

From Jan. 1, 2003 to Nov. 30, 2003 Health Canada received more than 200 reports of women suffering severe reactions to the drug. The reports were submitted by health professionals or by the women.

Their symptoms include severe depression and suicide attempts, to muscle weakness, weight gain, prolonged vaginal bleeding and hemorrhage, sleep disorders, breathing difficulties, slurred speech, pulmonary embolism, chest pain, confusion, decreased or no libido, convulsions, multiple fractures and pregnancy.

In the majority of cases, the use of Depo-Provera was the “suspected” cause of their problems.

Tina Cross is painfully aware of many of those symptoms. Cross, from Montreal, attempted to join a U.S. lawsuit, but was advised to start one in Canada. She now has a group of 250 women who have suffered adverse reactions.

“After my second child was born I was told I couldn’t take estrogen because of a blood disorder and latex allergy, and was told Depo-Provera would be safe to use while breastfeeding,” said Cross.

“Taking it made me depressed. I had emotional outbursts, chronic fatigue, diarrhea, food sensitivity, painful intercourse, loss of libido, sebaceous cysts under my arms and my daughter developed lumps in her breast.” Going off the shots gave her a “major depression, daily migraines, severe hair loss, vomiting and diarrhea, nightsweats and nightmares.”

Rose Ledrew, from Kitchener, Ont., suffered “terrifying” symptoms.

“The heart palpitations were frightening and I thought I was going to die from a heart attack. It’s poison, and because you take one shot every three months you have to wait for the effects to wear off,” said Ledrew.

“After only one shot on May 16, 2003, I didn’t stop bleeding until the end of September. My iron level went from 120 to 90. The doctor told me the only side-effects would be a slight weight gain and maybe some headaches.

Well, I gained over 20 pounds in two months.”

She also experienced severe depression, trouble breathing and numbness in both legs. She spent almost $4,000 on acupuncture treatments which, she said, stopped the bleeding.

Dr. Andre Marie Leroux, an obstetrician-gynecologist and acting division head of reproduction and urology in the therapeutics product branch at Health Canada, agrees Depo-Provera causes many women to suffer.

“I personally don’t like using that product. It’s not one of my favourites and I really try to consider alternatives,” said Leroux. He also said women younger than 35 who take the drug have twice the risk of developing breast cancer. However, if they don’t develop the cancer within the first four years on the drug, the risk of breast cancer is lower than in women of a similar age not on the drug.

A 1996 study in the U.S. showed that after two years on Depo-Provera, teenage girls had lost 3.1 per cent of their bone density. A 1994 British study suggested some women regain some bone density after discontinuing the drug, but not in the femoral neck — the area most prone to osteoporosis.

Depo-Provera is made by drug manufacturer Pharmacia, now owned by Pfizer.

It is made from oxyprogesterone, a synthetic form of the natural hormone progesterone, and acts on several levels of tissues, said Leroux.

The contraceptive is taken by injection once every three months, which makes it attractive for women who don’t want to take a pill every day.

Wayne Saray, Pfizer’s manager of corporate communications, said the drug’s product information label clearly outlines all serious side-effects of the drug.

“There are no plans to change the current monograph which was revised in September 2003, or communicate any warnings to physicians,” said Saray. “I suspect this is more of an issue to do with patient-physician communication.”

Health Canada approved Depo-Provera in 1997, after refusing it in 1992, because of a groundswell of protest from women across Canada.

“Because of that, an advisory panel was created to look at all the data, and the panel did recommend it should be approved in Canada although the side-effects are there,” said Leroux.

“It’s not the first option but for women who are intolerant of other contraceptives or can’t use an IUD (intra-uterine device), it may be an option to avoid unwanted pregnancy and end up with a therapeutic abortion. You have to be selective.”

Leroux said women should also be told that it can take many months, even years before they can conceive after taking Depo-Provera. Many women have no problem taking the drug, and Pharmacia does include a significant list of adverse reactions in information sent to doctors. Women should have access to that list, said Leroux, agreeing there is a lack of communication between doctors and patients.

“I’m convinced this is a key issue and it’s unfortunate, considering what may be the impact on the quality of life of a patient, but that’s often what’s missing in the day to day practice of medicine,” said Leroux.

“You never know before you write a prescription if the lady in front of you will be among the ones to experience the more serious side-effects.

Dr. Richard Bourke, a Windsor, Ont., obstetrician-gynecologist, agrees Depo-Provera should not be a first line contraceptive option. He said he wouldn’t encourage patients with pre-existing medical problems, hypertension or those who are obese to be on Depo-Provera.