Posicor (mibefradil)

Posicor (mibefradil) is a calcium channel blocker medication that relaxes and widens the blood vessels and is used to treat high blood pressure and chest pain. Posicor reduces the activity of certain liver enzymes that are important in helping the body eliminate many other drugs. Inhibiting these enzymes can cause some of these other drugs to accumulate in the body to dangerous levels.

Why Prescribed

Posicor is prescribed to treat hypertension and chronic stable angina (chest pain).

FDA Approved Uses

Posicor was approved by the FDA in 1997 for the treatment of high blood pressure and chest pain.

Side Effects

Side effects associated with Posicor include dizziness, headache, leg swelling, abdominal pain, nausea, unusual fatigue and nasal congestion.

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Warnings and Alerts

In 1998, Roche Laboratories, the makers of Posicor, announced they were withdrawing the drug from the market. When Posicor is combined with certain medications, it increases the risk of serious side effects. There were at least 143 deaths reported as a result of individuals taking Posicor, with the majority of deaths due to heart arrhythmias.

Drug Contraindications

Posicor is contraindicated in patients who use astemizole, terfenadine and cisapride due to life-threatening complications.

FAQ's

Despite Posicor's dangers, did the drug offer significant benefits that are not found in other, safer medications?

According to the FDA, the drug did not offer any significant benefits that are not currently found in safer medications.

Did the product labeling of Posicor discuss any drug interactions?

Yes, the product labeling warned patients not to use Posicor if they were currently taking certain allergy pills, tranquilizers, or sleeping pills. These medications included, but were not limited to: Cordarone, Hismanal, Vesture, Vesture, Neoral, Sandimmune, Cytoxan, Norpramin, Erythrocin, Ilosone, VePesid, Tambocor, Eulexin, Halfan, Ifex, Tofranil, Mevacor, Mexitil, Orap, Rythmol, Cardioquin, Quinaglute, Quinidex, Zocor, Prograf, Tamoxifen, Seldane, Mellaril, Velban, and Oncovin.

If there were concerns regarding Posicor's safety, why did the FDA grant approval?

Despite the fact that the FDA was aware of cases of heart arrhythmia and death associated with Posicor, it was unable to confirm these reports because Roche Laboratories did not make such reports public. Instead of delaying the approval for up to a year, the FDA approved the drug despite its concerns.

Should I contact an attorney if I have experienced severe side effects from using Posicor?

It may be important for you to contact an attorney who can help you protect your legal rights. Only a licensed attorney can evaluate whether you have a case that is worth pursuing. Keep in mind however that there may be time limits, known as statute of limitations, which impact on your ability to sue and receive financial compensation for your injuries.