Research shows that the antiviral drug pegylated interferon alfa-2b—sold under the brand name PegIntron—might cause life-threatening side effects and birth defects. If you’ve taken PegIntron, which is often administered in the form of an injection, and you believe it caused you or your child harm, you need a sympathetic advocate who will represent only your interests—and who will make the process of helping you to recover for your injuries as painless as possible.
The Rottenstein Law Group compassionately advocates for those who have suffered from the harmful side effects of potentially dangerous drugs. If you believe PegIntron harmed you or your child, contact RLG for a free, confidential legal consultation. We will evaluate your case and remain on the lookout for PegIntron recalls and PegIntron class action lawsuits. We might be the PegIntron law firm you are looking for.
What Is PegIntron and What Is Prescribed For?
PegIntron is the brand name for the drug pegylated interferon alfa-2b. Made and sold by Schering-Plough before it merged into Merck and Co., this prescription medication is used to treat chronic hepatitis C. The U.S. Food and Drug Administration (the FDA) approved it in January 2001, and Merck received FDA approval to sell it as a melanoma treatment in 2011, under the name Sylatron. Merck sells PegIntron as a subcutaneous injection in 1.5 mcg/kg/week doses for adults. PegIntron is frequently combined with Rebetol (ribavirin).
An interferon is a protein that cells release when pathogens such as viruses attack them. Its presence triggers a response by the immune system. Interferons also disrupt viruses’ replication processes. Injecting them into patients with serious viral infections helps speed up their recovery, though they aren’t as effective at destroying viruses as antibiotics are to bacteria. PEGylation is a process in which proteins are coated with an ethylene glycol polymer chains to prevent their destruction by natural processes. By PEGylating interferon alfa-2b, Merck found a way to ensure the interferon lasts longer in the body and helps fight hepatitis C.
PegIntron Might Cause Birth Defects and Life-Threatening Side Effects
When combined with Rebetol, PegIntron can cause severe birth defects, including fetal death. So dangerous is the combination that the FDA placed it in its Pregnancy Category X, the agency’s most serious category, and it placed its highest alert, a black box warning, on the PegIntron drug label. The FDA based its pregnancy categorization on animal tests that produced “significant teratogenic and embryocidal effects.” PegIntron’s label recommends that women should not start taking PegIntron with Rebetol until they receive a negative pregnancy test. It also advises PegIntron and Rebetol users to use two forms of contraception and take monthly pregnancy tests. The FDA even discourages women whose male partners are using the drugs from becoming pregnant.
The FDA placed PegIntron itself in its Pregnancy Category C because the drug has proven to cause spontaneous abortions when tested on rhesus monkeys. Although no studies on humans exist, the agency assumes that, taken on its own, PegIntron might have the same effect on humans.
Other Life-Threatening Side Effects
PegIntron’s drug label warns of several other severe life-threatening side effects, some of which appear in a second black box warning. According to that warning, PegIntron can cause or aggravate:
- Neuropsychiatric events (suicidal and homicidal ideation and behaviors, relapse of drug addictions and overdose, psychoses, hallucinations, and bipolar disorder);
- Cardiovascular events (hypotenstion, arrhythmia, tachycardia, cardiomyopathy, angina pectoris, myocardial infarction);
- Endocrine disorders (hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus);
- Ophthalmologic disorders (decrease or loss of vision, retinopathy, macular edema, retinal artery or vein thrombosis, retinal hemorrhages, cotton wool spots, optic neuritis, papilledema);
- Cerebrovascular disorders (stroke);
- Bone marrow toxicity;
- Autoimmune disorders (thyroiditis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, rheumatoid arthritis, interstitial nephritis, systemic lupus erythematosus, and psoriasis);
- Colitis (ulcerative or hemorrhagic/ischemic);
- Pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, and sarcoidosis); and
- Hepatic failure.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that getting satisfaction shouldn’t be just more hardship. That’s why we do everything we can to streamline the process of helping victims get the compensation they deserve.
If you have taken PegIntron alone or in combination with Rebetol or some other drug, and you believe it caused you or your child to suffer harmful side effects, contact RLG today. We will file a PegIntron lawsuit on your behalf if necessary. RLG will also keep you up to date on any PegIntron class action lawsuits, FDA PegIntron warnings, and PegIntron FDA recall announcements.