Daily Archives: June 27, 2014

Chantix

A recent article written in a Canadian medical journal revealed the results of a study done regarding the dangerous health risks associated with Chantix, an industry leader in products that help people quit smoking. The study determined that patients taking Chantix can heighten their risk of heart problems. These problems could lead to heart attacks. Dr. Sonal Singh, who is an assistant professor of general internal medicine working at John Hopkins University School of Medicine found that the drug can increase the chance of patients being diagnosed with irregular heartbeats. These new findings are among a host of other medical concerns that have surfaced through reports by patients, suits filed in court, and other medical studies since the product was released and hit the market in 2006.

In addition to heart problems, side effects associated with Chantix include hostility, depression, changes in mood and behavior and thoughts of suicide. Warnings are listed on the product label as well as a “boxed warning” from the Federal Drug Administration. A “boxed warning” is a label that has the highest safety restrictions issued by the FDA. This is due to the elevated risk of patients suffering from psychological conditions and episodes.

Another side effect that can be caused by Chantix is blackouts and loss of consciousness. This caused the Federal Aviation Administration to prohibit the use of Chantix for its pilots as well as air-traffic controllers. Anyone operating a public transportation vehicle and truck drivers are also banned from using the drug.

The Canadian medical study analyzed data results from clinical trials of more than 8,000 people with no medical conditions and in good health. Members of the study were either given a placebo or they were given the actual drug, Chantix. The findings published state that using Chantix was linked to a greater risk of patients suffering from serious heart conditions. This occurred in 52 out of 4,908 people who took the drug. With the placebo, an increase in heart problems was reported by only 27 out of 3,308 people.

Researchers agree that the risk is as high as 72%. This figure was reached through a statistical method used when reviewing more than one study. Dr. Singh and his associates analyzed and reviewed data from 14 studies that were conducted previously.

In the article, Dr. Singh explained that Chantix actually increased the baseline risk of smoker’s suffering from heart problems including congestive heart failure, heart attacks, and other heart related medical conditions. This contradicts the intent of smokers who want to quit and lower their risk of heart problems.

Pfizer, the company that makes and distributes Chantix, sticks by its product, stating that the drug has been used by over 7 million Americans. Pfizer did not agree with the findings of the study and professes that the actual number of heart-related issues was so low it was insignificant. The companies figures are as low as one quarter of one percent. In addition, Pfizer is working in conjunction with the FDA to review the current research and re-evaluate the safety of the drug.

Mirena

Mirena_200Today there are so many drug companies and doctors introducing women of child bearing age to the many forms of birth control. Often times women are encouraged to have an Intra-uterine device (IUD) or otherwise known as IUC (intra-uterine contraceptive) directly placed within the uterus to avert pregnancy. This is a T-shaped device implanted directly into the uterus by a trained medical professional. This type of contraceptive is a hassle free, no need to remember oral contraceptive preventing pregnancy for up to 5 years.

There are many types of IUCs in the industry today. Although, many women can have the implant and do just fine with them some experience serious, long lasting side effects. Not all medical devices are created equal which leads to manufacture warnings and risks that are associated with certain medical devices that are implanted.

Many women feel like they have been left in the dark when it comes to the possible side effect contraceptives such as Mirena. Mirena is an intra-uterine device that is placed within the uterus. Bayer is manufacturer that produces Mirena. Bayer claims that Mirena is long acting and a successful option that can be reversed for women of child bearing age. It offers a 99% success rate at preventing pregnancy.

Mirena is made up of levonorgestrel (generation synthetic progesterone) which is found in all birth control medications whether it is oral medication, injected medication, or implanted contraceptive devices. The IUD releases the hormone so that the cervical mucus becomes thicker and preventing a clear pathway for sperm to reach its destination. It begins to release the synthetic hormone as soon as it inserted in the correct location. This form of contraceptive claims to last at least 5 years and can be removed at any time although, like all contraceptives is not 100% guaranteed to prevent pregnancy from occurring.

It is not the device itself that can cause serious side effects; it is the levonorgestrel that is released from the device. It is not uncommon and quite normal in the first 90 days to 6 months to have light spotting or bleeding and irregular menstrual cycles. Eventually over 20% of the patients will have little to no bleeding over the course of the first year.

However, there are side effects that a woman may not put in direct correlation with Mirena. As with any intra-uterine devices there is always a risk of developing PID (Pelvic Inflammatory Disease) which can cause a woman to have an ectopic pregnancy. This is a risk that comes with Mirena and needs to be discussed with a healthcare professional. Patients wanting to use Mirena should have no history of ectopic pregnancies.

The light bleeding or spotting is common but what is NOT common is having lower back pain, weight gain, headaches, depression, stuffy nose, and abnormal pap smear which are all the negative side effects associated with Mirena. Most patients do not correlate these symptoms as related to Mirena.

Other side effects from using Mirena are the following but not limited to:

  1. Nervousness
  2. Breast pain
  3. Acne
  4. Decreased sex drive
  5. Skin disorder
  6. Hypertension
  7. Inflamed vagina (Vaginitis)
  8. Painful periods and or cramps
  9. Possible ectopic pregnancy (can cause infertility)
  10. Ovarian cysts
  11. Infertility due to PID (Pelvic Inflammation Disease)
  12. Perforation of the cervix or uterus
  13. Nausea
  14. Breast cancer
  15. Harm to breast feeding infants

Mirena is also marketed to mothers who have just given birth, some literature has encouraged getting Mirena inserted when having a c-section, but nowhere does it state the harmful effects it could have on a breast feeding baby. In fact, it has been reported that the newborns have had a higher incidence of respiratory infections and neurological disorders when mothers have elected to insert Mirena.

Often times after an IUD is placed there is no follow up, it is important to pay close attention to the body’s reaction when a device has been implanted. As with any drug or medication it is important to seek professional help and discuss all warnings and risks associated with the procedure.