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.
Posicor is prescribed to treat hypertension and chronic stable angina (chest pain).
Posicor was approved by the FDA in 1997 for the treatment of high blood pressure and chest pain.
Side effects associated with Posicor include dizziness, headache, leg swelling, abdominal pain, nausea, unusual fatigue and nasal congestion.
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.
Posicor is contraindicated in patients who use astemizole, terfenadine and cisapride due to life-threatening complications.
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.
Can I file a lawsuit if I have suffered damages from taking Posicor?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Posicor, you should contact your doctor immediately. You may also wish to contact an experienced Posicor lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.